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Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics, and Proprietary Products – Dr. Reddy’s is an active pharma API manufacturing company and pharmaceutical ingredient supplier for foremost formulators and offers a portfolio of products and services, including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.
Our API pharma business caters to leading innovator and generic companies across the US, Europe, Latin America, Japan, Korea, and other emerging markets. We consistently deliver high-quality APIs with deep technical strengths in developing complex APIs such as steroids, peptides, complex long-chain synthesis, and oncology.
As a pharmaceutical API manufacturer, our major therapeutic areas focus on gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy’s operates in global markets and is one of the top API manufacturers in the USA. As a pharma API supplier our major markets include – the USA, Europe, India, Russia, and other CIS countries.
About Dr. Reddy's API Business
250+ APIs
1980+ Drug master files across the global markets (1638 active DMFs)
State-of-the-art R&D centers in India, U.K., U.S. & Netherlands
8 API manufacturing sites - 6 in India & 1 in the UK & Mexico)
50+ Pipeline molecules (Filed + under development)
2000+ research scientists working on various projects
Our Achievements
Jul 10, 2025
CDP Recognition
Jun 24, 2025
Dr. Reddys API team at CPHI China 2025
Apr 9, 2025
Dr. Reddys API team at CPHI Japan 2025
Mar 17, 2025
Dr. Reddys API team at DCAT 2025
Nov 29, 2024
Dr. Reddy's API team at CPHI India 2024
Oct 13, 2024
Dr. Reddy's API team at CPHI Milan 2024
Apr 22, 2024
Dr. Reddy’s API at CPHI Japan 2024
Nov 30, 2023
Dr. Reddy’s at CPHI India 2023
Nov 11, 2023
Asia-Pacific Climate Leader Award
Oct 28, 2023
Dr. Reddy’s API at CPHI Worldwide 2023
Aug 20, 2023
Dr. Reddys at G20 Summit 2023
Jun 25, 2023
Dr. Reddy’s API at CPHI China 2023
Jan 5, 2023
Dr. Reddy's API calendar 2023
Nov 6, 2022
Addressing NDMAs in Pharmaceuticals
Sep 25, 2022
Dr. Reddys attended ACHEMA 2022 Conference
Apr 14, 2020
Dr. Reddy’s statement on the COVID-19 pandemic
Mar 1, 2020
US DMF for Apalutamide - Now available
Mar 1, 2020
Dr. Reddy's Sustainability Report 2018-19
Resources
New Product Alert – Ruxolitinib Phosphate
Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.This inhibition disrupts cytokine and growth factor signalling pathways, leading to a decrease in proinflammatory cytokines and chemokines, usually elevated in myelofibrosis and other inflammatory conditions. Furthermore, JAK1 regulates interleukin 2 and 6 and TNF alpha, while JAK2 involves many cellular functions, including proliferation and differentiation.Dr. Reddy's is an early mover in API development and planning to file the DMFs in key markets such as the US, China, Japan, Brazil, Europe, and Korea. We offer the anhydrous crystalline form (Innovator form).Our manufacturing process has been designed to address customized particle size distribution (PSD) requirements through size reduction and crystallization techniques to meet the most desired PSDs on a commercial scale consistently. Our API is developed at cGMP API manufacturing facilities and successfully inspected by international regulatory authorities. In addition, we have adequate capacity to meet global demands.To learn more about our API offerings, please read the product alert on Ruxolitinib Phosphate by filling in the contact form below.
Product Alert - Rimegepant
Rimegepant is a calcitonin gene-related peptide receptor antagonistOur Offerings*:Offers Crystalline Form (Innovator form 1.5 Hydrate)Alternate salt will provide 2 Years & 4 months advantage in Brazil & RussiaPlanning adequate capacity with a short lead time of 90 days.Lab samples and ATR availableParticle size distribution (PSD) - We can offer lower particle or customized sizes based on customer requirements.To learn more about our API offerings, please read the Product alert on Rimegepant by filling out the contact form below.
Product Alert – Mavacamten
CAS No. 1642288-47-8Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. Mavacamten shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with Mavacamten reduces dynamic LVOT obstruction and improves cardiac filling pressures.Dr. Reddy's API Offering*:Potential NCE-1 filing opportunity.Crystalline Form A (Validated).USDMF filed and DMF's planned for all other major marketsPlanning adequate capacity with a short lead time of 90 days.Regulatory compliance and quality ensure our API is genotoxic and nitrosamine-free, adhering to ICH M7 guidelines.Reliable suppliers for KSMs to ensure timely deliveries and strict adherence to specifications.To learn more about our API offerings, please read the tech sheet on Mavacamten API by filling out the contact form below.
New Product Alert - Ripretinib
Ripretinib works by binding to two key regions of the kinase (the switch pocket and activation loop), locking it in an inactive state. This prevents the kinase from promoting abnormal cell growth, effectively inhibiting a wide range of mutations in KIT and PDGFRA kinases.Our Offerings*:Offers stable crystalline Form 1.US & Brazil DMFs filed.Our current batch size is 8 Kg (Crystalline) and planning adequate capacity with a short lead time of 90 days.Regulatory compliance and quality ensure our API is genotoxic and nitrosamine-free, adhering to ICH M7 guidelines.We offer immediate samples with CoA and impurity profiles, allowing you to evaluate our API's quality and suitability.To learn more about our API offerings, please read the Product alert on Ripretinib by filling out the contact form below.
Product Alert - Lumateperone Tosylate
Lumateperone is a serotonin 5HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM), and a serotonin transporter (SERT) inhibitor. Unlike existing schizophrenia treatments, Lumateperone is a first-in-class molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate—three neurotransmitter pathways implicated in severe mental illness.Our Offerings*:We offer the crystalline form-A*Early mover in API development and filed USDMF. Planning to file the DMF in key markets such as China, Japan, Brazil, Europe, and Korea.Current batch size of 10-15 kg. Adequate capacity available to supply development quantity in a short lead time of 90-120 days.cGMP API manufacturing facilities, successfully inspected by international regulatory authorities.To learn more about our API offerings, please read the Product alert on Lumateperone by filling out the contact form below.
New Product Alert - Ribociclib
is a cancer medication that works by inhibiting the activity of specific enzymes called cyclin-dependent kinases (CDKs) 4 and 6. These enzymes play a critical role in the regulation of cell division, and their overactivity is commonly associated with the development of certain types of cancer, particularly breast cancerBy blocking the activity of CDK4/6, Ribociclib slows down the uncontrolled cell division that drives the growth of cancer cells. This helps to reduce the size of tumors and slows down the progression of the diseaseOur Offerings*:We provide Novel Form X and Innovator Form A, with non-GMP API available at kg scale and a short lead time of 90 days.As an early mover in Ribociclib API development, we plan to submit the USDMF for Form X by June 2025 and for Form A by September 2025.Our commitment to regulatory compliance and quality ensures our API is genotoxic and nitrosamine-free, adhering to ICH M7 guidelines.We offer immediate samples with CoA and impurity profiles, allowing you to evaluate our API's quality and suitability.To learn more about our API offerings, please read the Product alert on Ribociclib by filling out the contact form below.
New Product Alert - Ruxolitinib & Salts
Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.This inhibition disrupts cytokine and growth factor signalling pathways, leading to a decrease in proinflammatory cytokines and chemokines, usually elevated in myelofibrosis and other inflammatory conditions. Furthermore, JAK1 regulates interleukin 2 and 6 and TNF alpha, while JAK2 involves many cellular functions, including proliferation and differentiation.Dr. Reddy's is an early mover in API development and planning to file the DMFs in key markets such as the US, China, Japan, Brazil, Europe, and Korea. We offer the anhydrous crystalline form (Innovator form).Our manufacturing process has been designed to address customized particle size distribution (PSD) requirements through size reduction and crystallization techniques to meet the most desired PSDs on a commercial scale consistently. Our API is developed at cGMP API manufacturing facilities and successfully inspected by international regulatory authorities. In addition, we have adequate capacity to meet global demands.To learn more about our API offerings, please read the product alert on Ruxolitinib Phosphate by filling in the contact form below.
Tech Sheet On Nilotinib Hydrochloride
Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, Nilotinib inhibited BCR-ABL-mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ chronic myelogenous Leukemia (CML).Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Nilotinib HCL API (filed on July 08, 2022), and we are planning to file the EUDMF by March 2022 and we offer monohydrate from-B (Innovator form).Our manufacturing process has been designed to address customized particle size distribution (PSD) requirements through size reduction and crystallization techniques to consistently meet the most desired PSDs on a commercial scale. With an adequate capacity to meet global demand, we manufacture Nilotinib HCL at our cGMP API manufacturing facility, successfully inspected by international regulatory authorities. In addition, we have de-risked our supply chain as the key starting materials (KSM) of our Nilotinib Hydrochloride API are backward integrated today.To know more about our API offerings, please read the Tech sheet on Nilotinib Hydrochloride by filling in the contact form below.
Tech Sheet – Mirabegron API
CAS no. 223673-61-8Mirabegron is a ß-3 adrenergic receptor agonist and a widely prescribed oral drug for treating overactive bladder (OAB). The drug improves symptoms associated with OAB, such as urinary urgency or urgency incontinence.Mirabegron was approved under the trade names Myrbetriq (US, 2012), Betmiga (Europe, 2012), and Betanis (Japan, 2011). As of July 2023, Mirabegron is approved in 60 countries worldwide for OAB indications.Dr. Reddy's API OfferingWe manufacture Mirabegron at our cGMP API manufacturing facility (CTO-6, Vizag), which is successfully inspected by international regulatory authorities such as the USFDA, EMEA, ANVISA, PMDA and Health Canada.We offer Alpha Form-1 (same as the originator).API quality complies with most Stringent European Pharmacopoeia 11.2 monograph specifications.Employing a Quality by Design approach for efficient processes and high-quality output.Developing an atom-efficient process to minimise process waste.Effective control strategy for avoiding potential genotoxic and carcinogenic impurities.Assured process safety and scalability.To learn more about our API offerings, please read the tech sheet on Mirabegron API by filling out the contact form below.
Tech sheet – Apremilast
Dr. Reddy's API Offerings*:Dr. Reddy's is among the earliest generic API manufacturers globally for Apremilast API and filed the USDMF in September 2016 (Form-B) and June 2017 (Amorphous). Besides this, we have DMF filings in Canada and Brazil.Offers the same form as the innovator drug, facilitating successful bioequivalence studies.Manufacturing and Capacity:We manufacture Apremilast at our cGMP API manufacturing facility in Vizag (CTO-SEZ), which is successfully inspected by global regulatory authorities, including the US FDA, and is EU GMP certified too. We have sufficient capacity to supply the commercial quantities in a short lead time.To learn more, download the techsheet on Apremilast API HERE.Should you have any specific queries? I would be happy to schedule a meeting at your earliest convenience.*Note: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
Addressing the presence of mutagenic Azido impurities in Sartan APIs
In continuation to our efforts to understand the Azido impurities, we are evaluating the possibility of formation of two additional Azido impurities - Chloro methyl azido impurity and 4-Chloro azido methyl tetrazole impurity in Losartan potassium. Based on detailed synthetic landscape, it is found that these impurities are not potentially formed in our manufacturing process. The detailed assessment report for the same would be available in the coming few weeks.Dr. Reddy’s has continued to manufacture and deliver Sartan APIs in accordance with global regulations as a result of the processes and the analytical methods developed by our experts to avoid the presence of Nitrosamine and Azido impurities. We stay committed to ensure that we continue to provide high quality APIs to our partners.I will be happy to connect with you for any queries or further details on our assessment on Azido impurities in Sartan APIs. You can also log onto XCEED, our customer engagement platform, to raise any sample or technical queries on the topic.
Product Alert - Relugolix API
CAS No: 737789-87-6As an early mover in API development, we are committed to regulatory compliance, have DMFs filling in the US and Brazil, and plan to file the DMFs in significant markets. Our API is available in an anhydrous crystalline form (the innovator form), which can be provided in customized sizes based on your requirements. We also offer a finished dosage form of Relugolix in selected markets.Our synthetic process ensures consistent polymorph and amorphous forms for optimal in-vivo performance. Additionally, our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities.To learn more about our API offerings, please read the product alert on Relugolix API by filling out the contact form below.
Tech Sheet on Enzalutamide Premix
Chemical Name:4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N- methylbenzamide.Dr. Reddy's API Offerings*:Innovator has filed an Enzalutamide premix amorphous form manufactured through spray drying, which uses API and HPMCAS as excipients. We offer an Enzalutamide premix amorphous form with a non- infringing process and composition.Dr. Reddy's has a dedicated new manufacturing facility that offers Enzalutamide premix.Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Enzalutamide API.Besides USDMF, country-specific regulatory filings are necessary for global market expansion, so we have diversified our filling to all the major regulated markets.To learn more, download the Tech sheet on Enzalutamide Premix API HERE.Should you have any specific queries? I would be happy to schedule a meeting at your earliest convenience.*Note: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
Product Alert – Mirogabalin Besylate
Dr. Reddy's Offerings*:Planning USDMF by January 2025Offers crystalline Form-1Non-GMP API and COA are available.Quality Assurance through cGMP API ManufacturingManufacturing facilities have successfully undergone inspections by international regulatory authorities.Partnerships with reliable key starting materials (KSM) suppliers for timely deliveries and strict adherence to specifications.To learn more, download the product alert on Mirogabalin API HERE.Should you have any specific queries? I would be happy to schedule a meeting at your earliest convenience.*Note: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
Product Alert – Vonoprazan Fumarate
Dr. Reddy's Offerings:USDMF filed in februray 2024Offers crystalline innovator form.Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities. We have also employed a robust process to achieve the consistent polymorph (innovator form) and morphology to ensure the desired in-vivo performance.Our cGMP API manufacturing facility has undergone a thorough inspection by international regulatory authorities, and we have reliable suppliers for key starting materials to ensure timely deliveries and adherence to strict specifications. Moreover, we are equipped to provide sufficient capacity to supply development quantities within a short lead time of 90-120 days.To learn more about our API offerings, please read the product alert on Vonoprazan API by filling out the contact form below.
Tech Sheet - Cabozantinib (S)-malate API
Cabozantinib S-malate is an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity.Dr. Reddy's API Offering*We offer Cabozantinib S-malate – Crystalline form N2 (Innovator form).Cabozantinib HCl is an alternate salt providing 505(b)(2) opportunities in the US and early launch opportunities in Europe, Brazil, Turkey, Mexico, and South Korea.Dr. Reddy’s proposed synthetic process is IP-compliant.We employ a quality-by-design (QbD) approach for efficient processes and high-quality output.Effective control strategy for avoiding potential genotoxic and carcinogenic impuritiesAssured process safety and scalability.A short lead time of 120-180 days from the purchase order date (PO).To learn more about our API offerings, please read the Tech sheet on Cabozantinib API by filling out the contact form below.Note: *Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
Product Alert – Deucravacitinib API
CAS no. 1609392-27-9Dr. Reddy's API OfferingWe are targeting crystalline Form and working on other amorphous solid dispersions (ASDs) as well. Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities. We have also employed a robust process to achieve the consistent polymorph (innovator form) and morphology to ensure the desired in-vivo performance.Our cGMP API manufacturing facility has undergone a thorough inspection by international regulatory authorities, and we have reliable suppliers for key starting materials to ensure timely deliveries and adherence to strict specifications. Moreover, we are equipped to provideTo learn more about our API offerings, please read the product alert on Deucravacitinib API by filling out the contact form below.
Substantially Pure Carfilzomib Amorphous for Generic Launch
Kyprolis (carfilzomib) is a proteasome inhibitor that irreversibly binds to the N-terminal threonine-containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome. Carfilzomib had antiproliferative and proapoptotic activities in vitro in solid and hematologic tumour cells. In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumour growth.Dr. Reddy's API OfferingDr. Reddy’s Carfilzomib API is a notable example of the technical capabilities of product development. It offers our customers access to a generic API that shows distinct features of having optimal consumption co-efficient in line with the green chemistry concept and superlative quality resulting from a robust process at scale.We manufacture Carfilzomib amorphous API at our cGMP API manufacturing facility, successfully inspected by international regulatory authorities - USFDA, KFDA, WHO- GMP, Russian Federation, and ANVISA (document-based inspection completed and certificate is available).To achieve high supply assurance, our key starting materials (KSM) are sourced domestically, and one is from China.Continuous improvement is in place to achieve quality and supply excellence.The current batch size is about 1.5 kg (Per customer requirement, discrete lots can be supplied).To learn more about our API offerings, please read the product alert Carfilzomib API by filling out the contact form below.
Product Alert – Mavacamten API
CAS no. 1642288-47-8Mavacamten (Camzyos®) is the pioneering and singularly authorised cardiac myosin inhibitor designed to address hypertrophic cardiomyopathy (HCM) at its root cause. This unique compound acts as an allosteric and reversible inhibitor with a specific focus on cardiac myosin, allowing for the controlled adjustment of the myosin heads' activity, thus decreasing the formation of myosin-actin cross-bridges.Dr. Reddy's API OfferingWe are developing Innovator Crystalline Form A - Labs samples; COA is available.Alternate polymorph/ novel form will provide 4 to 6 years of advantage.Our cGMP API manufacturing facility has undergone a thorough inspection by international regulatory authorities, and we have reliable suppliers for key starting materials to ensure timely deliveries and adherence to strict specifications. Moreover, we are equipped to provide sufficient capacity to supply development quantities within a short lead time of 90-120 days.To learn more about our API offerings, please read the product alert on Mavacamten API by filling out the contact form below.
White Paper on Sugammadex API
Sugammadex is a medication used to reverse the effects of certain muscle-relaxing drugs (rocuronium and vecuronium) during anaesthesia. It works by forming a complex with these drugs, neutralizing their effects, and restoring muscle function, allowing for a rapid reversal of muscle relaxation. Sugammadex works by forming a complex with muscle-relaxing drugs (rocuronium and vecuronium), neutralizing their effects. This complex helps rapidly reverse muscle relaxation, restoring muscle function.Sugammadex sodium is one of the key molecules in Dr. Reddy’s API portfolio and an ideal use case on how a thorough understanding of the interaction between API and formulation can significantly improve the robustness of the formulation process considering the drug substance’s proneness to degradation in the formulation process.Our development approach:We adopted QbD (Quality by Design) and an integrated drug developmental approach, looking not only at the API but also studying the formulation. The QTPP (Quality Target Product Prole) of the API was determined considering the drug substance’s proneness to degradation in the formulation process, especially during the terminal sterilisation (TS) process for intravenous injection.To know more about our API offerings, please read the White paper on Sugammadex Sodium API by filling the contact form below.
Tech Sheet on Pregabalin API
Pregabalin's precise mechanism of action is not fully understood, but studies suggest that it binds to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding modulates the release of excitatory neurotransmitters and prevents the trafficking of the alpha2-delta subunit. Although pregabalin is structurally related to GABA, it does not directly bind to GABA or benzodiazepine receptors.Dr. Reddy's API OfferingOffers crystalline form-I i.e., Innovator form.The control strategy for the API impurity profile has been designed through quality-by- design (QbD) based development.Lactam impurity levels are not detected thus able to achieve USP/ EP compliance after milling - opening a possibility for a wide range of delivery systems like dispersible films, oral disintegrating tablets, etc.We manufacture Pregabalin API at our cGMP API manufacturing facility, which was successfully inspected by international regulatory authorities - WHO GMP, KFDA, PMDA, ANVISA, and USFDA.To know more about our API offerings, please read the Tech sheet on Pregabalin API by filling the contact form below.
Product Alert – Niraparib API
Niraparib binds to the PARP enzyme and prevents it from repairing single-strand breaks in DNA. This causes the cancer cell's DNA to become more damaged, leading to cell death. Since cancer cells often have more DNA damage than healthy cells, they are more sensitive to the effects of PARP inhibitors like Niraparib.Dr. Reddy's API OfferingDeveloping innovator Form (Tosylate monohydrate form 1), a gram sample can be offered.Particle size distribution (PSD) - We can offer customized particle sizes based on customer requirements.Reliable KSM suppliers added to ensure timely deliveries and adherence to stringent specifications.Planning adequate capacity to supply development quantity in a short lead time.To learn more about our API offerings, please read the Tech sheet on Niraparib API by filling out the contact form below.
Product Alert – Tucatinib API
Tucatinib is a small molecule tyrosine kinase inhibitor that selectively targets human epidermal growth factor receptor 2 (HER2). HER2 is a transmembrane receptor that is overexpressed in some types of cancer, including breast cancer.Tucatinib binds to the intracellular domain of HER2, which blocks the activation of downstream signalling pathways that promote cell growth and proliferation. Specifically, tucatinib inhibits the phosphorylation of HER2 and downstream proteins such as AKT and ERK.Dr. Reddy's API OfferingImproved route of synthesis (ROS) and process, cost-effective convergent synthesis (Dr. Reddy's filed provisional patent application).We plan to offer Form B Hemithanolate solvate and Amorphous form (Lab samples for the same are available).Reliable KSM suppliers added to ensure timely deliveries and adherence to stringent specifications.Planning adequate capacity to supply development quantity in a short lead time.To know more about our API offerings, please read the Tech sheet on Tucatinib API by filling the contact form below.
Product Alert – Pazopanib API
Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-α and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Tck), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (cFms) [2].In vitro - Pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR- beta receptors.In vivo - Pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in a mouse model, and the growth of some human tumor xenografts in mice.Dr. Reddy's API OfferingWe offer crystalline polymorph form.An early mover in API development and filled the USDMF in March 2021. In addition, we are planning to file the DMFs in China, Japan, Brazil, Europe, and Korea.Particle size distribution (PSD) - D (90) < 50 µ, based on customer requirements, we can offer lower particle or customized sizes.To know more about our API offerings, please read the Tech sheet on Pazopanib API by filling the contact form below.
Tech Sheet on Midostaurin API
Midostaurin is a small molecule that inhibits multiple receptor tyrosine kinases. In vitro biochemical or cellular assays have shown that Midostaurin or its major human active metabolites CGP62221 and CGP52421 inhibit the activity of wild type FLT3, FLT3 mutant kinases (ITD and TKD), KIT (wild type and D816V mutant), PDGFRα/β, as well as members of the serine/threonine kinase PKC (protein kinase C) family.Midostaurin has global sales of 188 million USD with a 74% year-over-year (YoY) growth and 58 Kg growth at 67% YoY. It is expected to become around 200 Kg market by 2025. The global Midostaurin market is projected to grow at a CAGR of 4.6% between 2022 and 2030.The growth is primarily driven by Europe, China, and the rest of the world (ROW) markets. In addition, more approvals for novel therapies and ongoing trials for all form of Acute myeloid leukemia (AML) would further propel the market during the forecast period (2021-2030).Dr. Reddy's API OfferingCrystalline form II (same as innovator form) and amorphous form.Dr. Reddy's is among the earliest generic API manufacturers globally to file the US DMF for Midostaurin API for both polymorph forms.Quality by design (QbD) based API development for a consistent quality profile.To know more about our API offerings, please read the Tech sheet on Midostaurin API by filling the contact form below.
Tech Sheet on Tofacitinib Citrate
Tofacitinib Citrate (Xeljanz) is an oral, small molecule drug used to treat adults with moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis, and moderate to severe ulcerative colitis. Tofacitinib works by blocking the body’s production of enzymes called Janus kinases (JAKs). Tofacitinib citrate is the first oral JAK inhibitor approved for use in chronic ulcerative colitisThe global drug sales of Tofacitinib (Xeljanz®) stood at 2.6 billion USD in 2022 and recorded a historical growth (CAGR) of 22% between 2017 to 2022. In addition, before losing patent protection in 2026, it is expected that Tofacitinib will witness peak sales at $2.8 billion in 2025.Dr. Reddy's API OfferingCrystalline polymorphic formCustomized particle size distribution (PSD), which plays a vital role in the formulation development.Our process involves efficient chemical transformations that offer a distinctive advantage concerning quality and manufacturability.We manufacture Tofacitinib citrate API at our cGMP API manufacturing facility, successfully inspected by international regulatory authorities - USFDA, KFDA, WHO-GMP, Russian federation, and ANVISA (document-based inspection completed and certificate is available).To know more about our API offerings, please read the Tech sheet on Tofacitinib citrate API by filling the contact form below.
Tech Sheet on Dutasteride
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the prostate gland's initial development and subsequent enlargement. Testosterone is converted to DHT by the enzyme 5-alpha-reductase, which exists as 2- isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver [1].Dutasteride is indicated for treating symptomatic benign prostatic hyperplasia (BPH). When combined with the alpha-adrenergic antagonist, tamsulosin is indicated for treating symptomatic BPH in men with an enlarged prostate [1]. Furthermore, Dutasteride is also approved for treating male androgenic alopecia in South Korea and Japan at a dose of 0.5mg/ day [2].Dr. Reddy's API OfferingWe offer polymorphic crystalline form 2.A novel synthetic process developed for crystalline form 2.Quality by design (QBD) based API development for a consistent quality profile.We manufacture Dutasteride API at our cGMP manufacturing facility, which was successfully inspected by international regulatory authorities - USFDA, WHO GMP, KFDA, PMDA, Health Canada, and ANVISA. We have reliable KSM suppliers to ensure timely deliveries and adhere to stringent specifications.To know more about our API offerings, please read the Tech sheet on Dutasteride API by filling the contact form below.
Tech Sheet on Linagliptin
Linagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4), an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis.We are among the earliest generic API manufacturers globally to file the USDMF for Linagliptin API. The DMF for Korea is also filled. We offer country-specific regulatory filings for global market expansion, so we are diversifying our filing to all the major regulated markets.Our API offerings:We offer a mixture of crystalline Form A and Form B - a prior art formA process which is improved and disclosed in the product patent and designed around the innovator's process IP.Quality by design (QbD) based API development for a consistent quality profileOur process has been designed to address customized PSD requirements through size reduction and crystallization techniques to consistently meet the most desired PSDs at a commercial scale.To know more about our API offerings, please read the Tech sheet on Linagliptin by filling the contact form below.
Tech Sheet on Voriconazole
Voriconazole (Vfend®) is an azole antifungal indicated for invasive aspergillosis candidemia (non- neutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds, and esophageal candidiasis. Furthermore, it is used to treat serious infections caused by scedosporium apiospermum and fusarium species, including fusarium solani, in patient’s intolerant of, or refractory to other therapy.Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Voriconazole API. Besides the USDMF, we have regulatory filings available for Canada, CEP, China, and Israel. We manufacture Voriconazole at our cGMP API manufacturing facility, which was successfully inspected by international regulatory authorities including WHO GMP, KDMF, PMDA, COFEPRIS, and MHRA.Our process has been designed to address customized PSD requirements through size reduction and crystallization techniques to consistently meet the most desired PSDs at a commercial scale.To know more about our API offerings, please read the Tech sheet on Voriconazole by filling the contact form below.
Co-Crystal and Customized Particle Size for Early Launch Opportunity of Siponimod API
Siponimod is an oral, second-generation sphingosine-1-phosphate (S1P) receptor modulator. S1P receptor modulators can inhibit the egress and recirculation of lymphocytes from lymph nodes, a therapeutic strategy for treating certain autoimmune diseases.Siponimod is the first and only treatment for patients with active secondary progressive multiple sclerosis (SPMS). The drug is expected to address the critical unmet need of multiple sclerosis patients in various disease categories [1].Dr. Reddy’s Siponimod API is another example of the technical capabilities of our product development team. We can provide our partners with a Siponimod Hemifumarate API, which is thoroughly characterized by its structure using techniques like MicroED, single crystal PXRD, DSC, Raman, FT-IR, and NMR (solid-state and solution). Siponimod Hemifumarate was confirmed as a co- crystal, and it exists as a 2:1 co-crystal of Siponimod and fumaric acid rather than fumarate salt.To know more about our API offerings, please read the White Paper on Siponimod by filling the contact from below.
New Product Alert – Lumateperone Tosylate API
Lumateperone is a serotonin 5HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM), and a serotonin transporter (SERT) inhibitor. Unlike existing schizophrenia treatments, Lumateperone is a first-in-class molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate—three neurotransmitter pathways implicated in severe mental illness.Market Overview:The worldwide prevalence of schizophrenia is approximately 0.5 to 1%. It is one of the leading causes of disability worldwide, with a life expectancy of around 15 years less than individuals without schizophrenia.Approximately 50% of individuals with schizophrenia experience a relapse/exacerbation in psychotic symptoms within one year after their last episode; most relapses occur in medication non-adherence.According to global data, the bipolar disorder market is expected to grow from $4.1 billion in 2020 to $4.9 billion by 2030 at a compound annual growth rate (CAGR) of 1.7%. Furthermore, as the number of cases remains relatively stable over the forecast period (10 years), Lumateperone Tosylate is expected to become a top-three anti-psychotic drug and hit $1.2 billion in global sales across various indications by the financial year 2030-31.To know more about our API offerings, please read the new product alert on Lumateperone Tosylate by filling the contact from below.
Tech sheet: Dr. Reddy's Bempedoic Acid API Offerings
Bempedoic acid (Brand: Nexletol, Innovator: Esperion) is an essentially new, oral treatment option approved for patients needing further LDL-C lowering beyond maximally tolerated statin therapy. Bempedoic acid is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients.Bempedoic acid acts by inhibiting ATP citrate lyase. It is a prodrug activated only in the liver, thus preventing the muscle related adverse events seen with statins.Esperion’s product was approved in the US in February 2020 and Europe in April 2020. It has also inked a commercialization deal with Otsuka in Japan and entered into an exclusive licensing agreement with Daiichi Sankyo for South Korea, Brazil, Taiwan, Hong Kong, Macao, Thailand, Vietnam, Myanmar, and Cambodia.Bempedoic acid is available in two approved formulations:180 mg tablet of bempedoic acidFixed-dose combination of 180 mg bempedoic acid and 10 mg ezetimibe.Dr. Reddy’s is well-positioned to meet the global demand for bempedoic acid. We have established solid strategic sourcing, logistics partnerships and work closely with our customers to successfully manage the capacities of our manufacturing units ahead of launches.Are you interested in adding bempedoic acid to your portfolio? Please get in touch with us at api@drreddys.com. To know more about our offering and pipeline products, Log in to our customer service portal XCEED (https://api.drreddys.com/customer_portal/login).
Tech sheet: Dr. Reddy's Olaparib API Offerings
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostases, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib is indicated:As monotherapy in patients with deleterious or suspected deleterious germline.BRCA (breast cancer gene) mutated (as detected by an FDA-approved test) or advanced ovarian cancer after three or more prior lines of chemotherapy.Lynparza® is the leading PARP (poly (ADP-ribose) polymerase inhibitor approved in over 64 countries to treat ovarian cancer and in 40 countries for breast cancer. Below are the timelines of FDA approvals of Olaparib across indications.Dr. Reddy’s is among the earliest generic API manufacturers globally to file the USDMF for Olaparib API. In addition to the USDMF, considering the requirement of country-specific regulatory filings, we plan to diversify our drug master files (DMFs) with regulatory filling across various countriesTo know more about our API offerings, please read the technical sheet on Olaparib by filling the contact from below.
Tech sheet: Dr. Reddy's Enzalutamide API Offerings
Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signalling pathway. Enzalutamide has been shown to inhibit androgen binding to androgen receptors competitively and consequently inhibits nuclear translocation of androgen receptors and their interaction with DNA.Enzalutamide is presently one of the most promising therapy in the prostate cancer space. It is already an off-patent product in some markets and will be a generic in the United States and Europe by 2028. In 2021, the global market for Enzalutamide is 5.6 metric ton ($4.6 billion).To know more about our API offerings, please read the technical sheet on Enzalutamide by filling the contact from below.
Tech Sheet - Dr. Reddy’s Eribulin Mesylate API offerings
Eribulin Mesylate (Halaven®) is a microtubule inhibitor indicated to treat patients with:Metastatic breast cancer who have previously received at least two chemotherapeutic regimens to treat metastatic disease.Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.As per global data analytics, global annual sales volumes of Eribulin Mesylate were at $392 million, including $153 million from the US, $126 million from Europe, and $112 million from the rest of the world. As of February 2022, Eribulin Mesylate (Halaven®) is approved in 39 countries worldwide.To know more about our API offerings, please read the technical sheet on Eribulin Mesylate by filling the contact from below.
Tech Sheet – Dr. Reddy’s Fexofenadine API offerings
Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine Hydrochloride is indicated for:The relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age.To treat uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age.Dr. Reddy's is among the earliest generic API manufacturers globally to file the US DMF for Fexofenadine Hydrochloride API. In addition to the US DMF, considering the requirement of country-specific regulatory filings, we have diversified our DMFs with regulatory filling in countries such as Europe, Japan, Brazil, Australia, and New Zealand.To know more about our API offerings, please read the technical sheet on Fexofenadine Hydrochloride by filling the contact from below.
Tech Sheet - Dr. Reddy’s Azacitidine API offerings
Azacitidine is a nucleoside metabolic inhibitor indicated to continue treating adult patients with acute myeloid leukemia. In addition, it is indicated for use in adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy.FDA approved the original dosage form, i.e., Vidaza (Injectable), to treat myelodysplastic syndrome (MDS) and new oral dosage form, i.e., Onureg® (Azacitidine tablets) as a continued treatment for adults in the first remission with acute myeloid leukemia [3].The annual sales of the innovator oral formulation for the four quarters ending September 2021 is ~ $ 51 million [4], almost entirely from sales in the US. Analyst reports estimate peak sales forecasts for Onureg® at ~ $730 million to $1.5 billion after the US approval.To know more about our API offerings, please read the technical sheet on Azacitidine by filling the contact from below.
Tech Sheet - Dr. Reddy’s Ramipril API offerings
Ramipril is an angiotensin-converting enzyme (ACE) inhibitor indicated for treating hypertension to lower blood pressure. ACE inhibitors inhibit the angiotensin-converting enzyme (ACE) actions, thereby reducing the production of angiotensin II and decreasing the breakdown of bradykinin. The decrease in angiotensin II results in relaxation of arteriole smooth muscle leading to a reduction in total peripheral resistance, reducing blood pressure as the blood is pumped through widened vessels.Ramipril works by lowering blood pressure and reducing the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. In addition, Ramipril, in combination with thiazide diuretics, is used to treat hypertension.Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Ramipril API. On October 4, 2000, the FDA approved the original dosage form, i.e., Altace® capsules, to reduce the risk of myocardial infarction, stroke, and cardiovascular diseases.To know more about our API offerings, please read the technical sheet on Ramipril by filling the contact from below.
Tech Sheet - Dr. Reddy’s Gemcitabine API offerings
Gemcitabine Hydrochloride is an analog of the antimetabolite nucleoside deoxycytidine with antineoplastic activity. Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycytidine di-and triphosphate (dFdCDP and dFdCTP)dFdCDP - Inhibits ribonucleotide reductase, decreasing the deoxynucleotide pool available for DNA synthesis.dFdCTP - Incorporates into the DNA, resulting in DNA strand termination and apoptosis.The timelines of USFDA approval of Gemcitabine Hydrochloride across indications are as follows:U.S. Food and Drug Administration (USFDA) approved Gemcitabine Hydrochloride to treat non-small cell lung cancer in 1998 and for treating metastatic cancer in 2004.The U.S. Food and Drug Administration (USFDA) has approved Gemzar® (Gemcitabine Hydrochloride), in combination with Taxol® (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer in 2004. In addition to the United States, Gemzar has been approved for metastatic breast cancer in 32 countries today.Gemzar is approved in more than 90 countries and is the worldwide standard of care for pancreatic cancer and non-small cell lung, bladder, and breast cancers in many parts of the world.To know more about our API offerings , please read the technical sheet on Gemcitabine HCL by filling the contact from below.
Tech Sheet: Dr. Reddy’s Abiraterone Acetate API offerings
Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 selectively and irreversibly via a covalent binding mechanism. Abiraterone is a CYP17 inhibitor indicated in combination with prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) and Metastatic high-risk castration-sensitive prostate cancer (CSPC).Abiraterone Acetate (Zytiga, Janssen Biotech Inc.) was approved by the Food and Drug Administration (FDA) on April 28, 2011, for Prostate Cancer treatment. In December 2012, FDA expanded Zytiga’s use for late-stage Prostate Cancer. In February 2018, the FDA approved Abiraterone Acetate tablets with prednisone for metastatic high-risk castration sensitive prostate cancer (CSPC).As of February 2008, Abiraterone is approved in various countries worldwide for different indications.Key takeaways of Dr. Reddy’s Abiraterone Acetate API:Enough capacity to cater to current market requirements.Quality – in line with ICH guidelines.Earliest generic API manufacturer of abiraterone globally.Country-specific regulatory filingsGTI & Nitrosamine free.To know more about our offerings , please read the technical sheet on Abiraterone Acetate by filling the contact form below.
White Paper: Redyx: Remdesivir formulation developed at Dr. Reddy’s under the license from Gilead
Remdesivir is the First treatment approved by the US FDA for the treatment of COVID-19 in adult and paediatric patients (12 years or older, and weighing at least 40 kg) that require hospitalization. It is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), essential for viral replication. In addition to the US FDA, Remdesivir has been authorized for emergency use for the treatment of COVID-19 by several regulatory agencies, including EMA (European Medicines Agency), MHLW (Ministry of Health, Labour and Welfare), PMDA (Pharmaceuticals and Medical Devices Agency, Japan), and CDSCO (Central Drugs Standard Control Organisation, India).To know more about our offerings please read the whitepaper on Remdesivir by filling the contact form.
Whitepaper : Dr.Reddy's 2 DG- A promising treatment in hospitalized COVID-19 patients
2-Deoxy-D-Glucose (2-DG) is an anti-viral and anti-inflammatory drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS) of Defense Research and the Development Organization (DRDO). Dr. Reddy's collaborated with DRDO to conduct clinical trials for 2-DG in COVID-19 patients. Based on phase II and the phase III studies in India, 2-DG has received an emergency use authorization as an adjunct therapy in moderate to severe COVID-19 patients in the hospital setting.Dr. Reddy's is the first firm to successfully provide access to 2-DG for COVID-19 patients. As a result, we are able to offer our customers early access to the API and finished formulation for specific markets. Want to know more ? please fill in the contact details to read the whitepaper on our 2 DG API and finished product offerings.
Techsheet: Dr.Reddy's Lenvatinib API offerings
Lenvima is an oral tyrosine kinase inhibitor approved in multiple indications, including differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.We offer two polymorphic forms:1) Lenvatinib Mesylate MIBK solvate2) Lenvatinib Mesylate Form-C.A MIBK solvate is a novel form that offers in several markets an early launch advantage over the polymorph patent.The US DMF has been filed for both forms:* Lenvatinib Mesylate MIBK solvate in June 2018.* Lenvatinib Mesylate Form-C anhydrous in June 2021.We are well-positioned to meet the global demand for Lenvatinib API, with the ability to scale-up to meet commercial requirements whenever needed. Want to know more about our API offerings, please fill in the contact details below.
ROXADUSTAT - a multipronged development strategy
In this whitepaper, we outline how various strategies for the development of Roxadustat resulted in a successful filling of the USDMF in March 2020 to help our partners across geographies provide patients early treatment access.Roxadustat is a first-in-class small molecule oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and increases the endogenous production of erythropoietin, which stimulates the production of haemoglobin and red blood cells. This innovative approach has ordered a breakthrough in treating patients with anaemia in chronic kidney disease (CKD).We can address customized particle size distribution requirements through size reduction and crystallization techniques to meet the most desired particle size distributions consistently at a commercial scale.To know more about our offerings , please read the technical sheet on Roxadustat by filling the contact from below.
Dr.Reddy's Apremilast API and finished formulation offerings.
Dr. Reddy's is one of the leading API pharma companies supplying Apremilast API globally, and has led the USDMF filing in September 2016 (Form-B) and June 2017 (Amorphous).Apremilast, is an anti-inflammatory agent modulating a wide range of inflammatory mediators in psoriasis and psoriatic arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis and moderate to severe plaque psoriasis.Dr. Reddy's amorphous API has been successfully formulated into drug products by various formulators with successful bioequivalence studies and subsequent dossier filing.To know more about our offerings , please read the technical sheet on Apremilast by filling the contact from below.
Dr. Reddy’s Fosaprepitant API offerings
Fosaprepitant is indicated for preventing acute and delayed nausea and vomiting associated with moderately or highly emetogenic chemotherapy combined with other antiemetic agents. The US FDA and EMA approved fosaprepitant in 2008, and the PMDA in 2011. As of December 2020, this corresponds to an API demand of 500 kg per year (IQVIA MAT).We offer stable amorphous API which meets global regulatory requirements and formulation needs of customers. To know more about Dr. Reddy’s Fosaprepitant offerings Read the technical sheet on this topic by filling the contact form below.
Apixaban API – ready-to-compress granules and finished dosage forms
Dr. Reddy's is among the earliest global generic API manufacturers for Apixaban API and filed the USDMF in September 2015. Our customers have access to the high-quality API in customized particle sizes to facilitate formulation development.Apixaban is an anticoagulant medication approved under the trade name Eliquis in Europe in 2011, and in the US in 2012. It was first approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.Read the technical sheet on this topic by filling the contact form below.
Apalutamide API – an attractive NCE-1 opportunity for generic pharma companies
Prostate cancer accounts for 7.3% of all incident cases of cancer globally, as per estimates released by Globocan 2020. The 5-year prevalence of prostate cancer is estimated at ~ 5 million worldwide, making it the second most common cancer among men.Apalutamide is an oral second-generation, nonsteroidal androgen receptor inhibitor and became the first FDA-approved drug for non-metastatic castration-resistant prostate cancer patients. It received additional approval in 2019 for metastatic hormone-sensitive prostate cancer and is in phase 3 trials for metastatic hormone-refractory prostate cancer.Our API allows formulators to choose an IP-compliant market entry that meets the regulatory requirements. The key aspects of our offering are: To continue reading our whitepaper, please fill in the contact form below
Colloidal Iron Complex Formulations – Understanding and Developing the Process
This whitepaper describes the challenges involved in developing iron-carbohydrate complexes, including the parameters required to demonstrate physicochemical equivalence and summarises our expertise in addressing them. Iron carbohydrate complexes are a hybrid of inorganic and organic molecules. The molecule's key structural elements are architected /governed by the defined process unit operations and materials used in the process. Any subtle variation in the process unit operation can alter the structural features of the iron carbohydrate complexTo continue reading, please fill in the contact form below
Rivaroxaban from Dr.Reddy’s: Full basket offerings of API and Finished formulations
Dr. Reddy’s is among the earliest generic API manufacturers globally for Rivaroxaban API and filed the USDMF in March 2014. Dr. Reddy’s process involves a selective and efficient chemical transformations that offer distinctive advantage for quality and manufacturability. The process eliminates the potential impurities formed in the process, and can be robust and safely operated at a commercial scale.In selected markets, we can also provide the formulated drug product of Rivaroxaban and will support you in all regulatory aspects from filing to registration.To know more about our Rivaroxaban offerings, read the tech sheet by filling the contact form below.
Dr. Reddy's Mirabegron API offering in both alpha and amorphous form
Read through our technical sheet on Mirabegron API to get a glimpse of our multi-step scalable synthetic approach with effective analytical characterization resulting in a highly pure API. Dr. Reddy's is among the earliest generic API manufacturers globally and filed the USDMF for Mirabegron API (α-form) in June 2014. We have also developed an amorphous form of Mirabegron, which has been filed in the US in February 2015.Read the technical sheet on this topic by filling the contact form below.
Palbociclib – how a novel process development approach provides IP advantages
This whitepaper outlines how Dr. Reddy's holistic development approach can help our API partners across geographies to provide patients early access to the generic alternative of Palbocicilb while gaining or maintaining competitive advantages.Our team of process experts draw on their integrated understanding of IP, process development (API and formulation), and API manufacturing to ensure that by design the process is lean, free from potential genotoxic impurities and scalable to manufacture for early market entries.To continue on reading our latest whitepaer please fill the contact form below :You can also explore our Palbocicilb API offering by clicking on the link below:https://api.drreddys.com/product/palbociclib
Dr. Reddy's Elagolix API offering leverages a well rounded Quality by Design approach
The technical product sheet on our Elagolix API describes the Quality by Design (QbD) approach taken by Dr. Reddy's R&D team to develop the product. As a result, Dr. Reddy's is one of the first and few generic API manufacturer in the world to successfully validate the Elagolix API process early and at commercial scale.Read the technical sheet on this topic by filling the contact form below.You can also explore our Elagolix offering by clicking on the link below:https://api.drreddys.com/product/elagolix-sodium
Sacubitril/Valsartan (LCZ696) – Bringing yet another advantage through innovative API offerings
Our team of process and analytical experts draw on their integrated understanding in both the development and manufacturing of the API and the formulation. This is of particular importance when it comes to the characterization of a molecular complex which is critical for a successful API and formulation development. This holistic view, also helps to better understand the impact of the formulation process on the molecular integrity and stability of the product. As a result, our development of this supra molecular complex, was able to robustly match the characteristics of the reference listed drug (RLD).Read our latest whitepaper on this topic by filling the contact form below.You can also explore our Sacubitril/Valsartan (LCZ696) offering by clicking on the link below:https://api.drreddys.com/product/sacubitril-valsartan
Dr. Reddy’s Flow Chemistry experts share their perspectives in panel discussion of Chemistry Today
June 2020Dr. Reddy’s Flow Chemistry experts, Srividya Ramakrishnan and Rakeshwar Bandichhor, recently participated in the panel discussion of Chemistry Today, where they shared their perspectives on flow technology and its potential to become a superior manufacturing alternative for complex synthesis of Active Pharmaceutical Ingredients (API).Please fill the contact us form below to read the article on this topic.The complete publication is available on the link below:https://www.teknoscienze.com/tks_article/panel-discussion-on-flow-chemistry-3/
A closer look on how Dr. Reddy's met the stringent regulatory requirement of genotoxic impurities in Ranolazine
Genotoxic impurities (GTIs) have recently challenged the pharmaceutical industry by virtue of their presence at a level of parts per million (ppm) in drug products, especially in high dosage molecules like Ranolazine, which has a prescribed maximum daily dosage (MDD) of 2000 mg.In this whitepaper, we talk about steps taken by Dr. Reddy's during the product development phase to address this challenge by designing the process in such a way that all these PGIs / GTI’s are within the control in the manufacturing approach followed by Dr. Reddy’s for Ranolazine.Read our latest whitepaper on this topic by filling the contact form below.You can also explore our Ranolazine API offering by clicking on the link below:https://api.drreddys.com/product/ranolazine
Famotidine and Nizatidine APIs: NDMA controlled, customized particle distribution, supply chain security
For more than two decades, Dr. Reddy's has been recognized as one of the largest manufacturers of H2 receptor antagonist APIs such as Famotidine and Nizatidine. Our Tidine APIs are used by formulation companies across Europe, US, Japan, Middle-East and Asia Pacific.Manufactured and controlled in accordance with the international guidelines on nitrosamine impurities, these APIs are available in customized particle size distribution to ideally meet your formulation needs.Read the tech sheet on Famotidine and Nizatidine by filling the contact form below.You can also explore our Tidine API offerings by clicking on the links below:Famotidine: https://api.drreddys.com/product/famotidineNizatidine: https://api.drreddys.com/product/nizatidine
Meeting the New Regulatory Requirements in Sartan API Production
Manufacturer of APIs are now required to review their manufacturing processes and prove the absence of nitrosamine impurities. This whitepaper outlines the regulations and a case study on how Dr. Reddy’s Sartan API’s (such as Valsartan) already addresses future requirements.You can review our Sartan portfolio by clicking on the following links:Valsartan - https://api.drreddys.com/product/valsartanLosartan - https://api.drreddys.com/product/losartan-potassiumTelmisartanIrbesartan
API Manufacturing
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Customer Service
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API Manufacturing
With an industry-leading portfolio of generic APIs and a proven track record in drug product development, we are among the earliest pharma API manufacturers with a vast portfolio of APIs and the preferred API partner of choice for pharma companies than 80+ countries. Our API manufacturing facilities are complemented by formulation facilities supplying various dosage forms.
We are multi-sourced on our KSMs for a sustainable supply; we have reliable KSM suppliers to ensure timely deliveries and adhere to stringent specifications. Moreover, with additional capacity enhancement and API manufacturing facilities, we are among the top API manufacturing companies in India. As a result, we are well-positioned to meet the global demands of essential APIs and future supply requirements.
As a top API manufacturer in India, our API manufacturing facilities are operated in accordance with cGMP (ICH Q7) and are regularly inspected/audited by international regulatory authorities. We have eight commercial USFDA-inspected manufacturing units, of which six are in India and one in Mexico and the UK.
Dr. Reddy's API supplies high-quality, affordable APIs to leading generic formulations manufacturers and is the preferred API supplier to pharma companies worldwide. Dr. Reddy's API business thrives on the deep technical strengths proven over the last three decades in developing and manufacturing complex APIs.
The API division is strategically working towards becoming the number one API manufacturing companies in the world by focusing on solid innovation, global footprint, and exceptional customer service.
Selecting a world-class API and active pharmaceutical ingredient manufacturer is one of the most critical decisions a pharmaceutical manufacturer will make. So, choose your API wisely from the largest API manufacturers in India. To know more about the portfolio of our APIs and its services, place a query or contact our team at: api@drreddys.com