Meet with our product experts in one-on-one virtual sessions and get a deep insight into our API Pharma product offerings
Our experts will answer your questions, provide advice, and help you understand our product better.
Set up a meeting
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
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 – 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.
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.
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 [email protected]. 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.
Relatório Branco: A formulação de Remdesivir desenvolvida no Dr. Reddy’s sob a licença de Gilead:
Remdesivir é o primeiro tratamento aprovado pela FDA americana para o tratamento de COVID-19 em pacientes adultos e pediátricos (12 anos ou mais, e pesando ao menos 40 kg) que requerem hospitalização. É um inibidor da RNA polimerase RNA-dependente do SARS-CoV-2, essencial para a replicação viral. Adicionalmente à FDA americana, Remdesivir foi autorizado para uso de emergência para o tratamento de COVID-19 por várias agências regulatórias, incluindo EMA (Agência de Medicamentos Europeia), MHLW (Ministério da Saúde, Trabalho e Bem-estar), PMDA (Agência Farmacêutica e de Dispositivos Médicos, Japão), e CDSCO (Organização Central de Controle de Padrão de Drogas, Índia).Para saber mais sobre nossos oferecimentos por favor leia o relatório branco sobre Remdesivir preenchendo o formulário de contato.
Relatório branco : Dr. Reddy’s 2 DG – Um tratamento promissor em pacientes hospitalizados por COVID-19
2-Deoxi-D-Glucose (2-DG) é uma droga antiviral e anti-inflamatória desenvolvida pelo Instituto de Medicina Nuclear e Ciências Aliadas (INMAS) da Organização de Pesquisa de Defesa e Desenvolvimento (DRDO). Dr. Reddy’s colaborou com DRDO para conduzir ensaios clínicos para 2-DG em pacientes com COVID-19. Baseado em estudos fase 2 e 3 na Índia, 2-DG recebeu uma autorização de uso de emergência como terapia adjunta para moderar pacientes com COVID-19 severa no contexto hospitalar.Dr. Reddy’s é a primeira empresa a fornecer com sucesso acesso a 2-DG para pacientes com COVID-19. Como resultado, nós podemos oferecer aos nossos clientes acesso precoce a API e às formulações finais para mercados específicos. Quer saber mais? Favor preencher os detalhes de contato para ler o relatório branco sobre nosso API 2-DG e ofertas de produto final.
Folha técnica: Ofertas de API Lenvatinib do Dr. Reddy
Lenvima é um inibidor de tirosina quinase oral aprovado em múltiplas indicações, incluindo câncer de tiroide diferenciado, carcinoma de células renais, carcinoma hepatocelular, e carcinoma endometrial.Nós oferecemos duas formas polimórficas:1) Mesilato de Lenvatinib solvato MIBK2) Mesilato de Lenvatinib Forma-C.Um solvato MIBK é uma nova forma que oferece em vários mercados a vantagem de um lançamento precoce sobre a patente polimórfica.O DMF americano foi preenchido para ambos os formulários:* Mesilato de Lenvatinib solvato MIBK em junho de 2018.* Mesilato de Lenvatinib forma-C anidra em junho de 2021.Nós estamos bem-posicionados para encontrar a demanda global de Lenvatinib API, com a habilidade de aumentar para suprir requerimentos comerciais quando necessário Se quiser saber mais sobre nossas ofertas de API, favor preencher os dados de contato abaixo.
ROXADUSTAT – uma estratégia de desenvolvimento com várias pontas
Nesse relatório branco, nós delineamos como várias estratégias para o desenvolvimento de Roxadustat resultaram em um preenchimento correto da USDMF em março de 2020 para ajudar nossos parceiros através de geografias a fornecer a pacientes acesso precoce ao tratamento.Roxadustat é umamolécula oral primeira-na-classe de fator hipóxia-induzível inibidor de prolil hidroxilase (HIF-PHI) e aumenta a produção endógena de eritropoetina, que estimula a produção de hemoglobina e células vermelhas. Essa abordagem inovadora causou um avanço no tratamento de pacientes com anemia em doença renal crônica (CKD).Nós podemos endereçar os requerimentos de distribuição de partículas de tamanho customizado através da redução de tamanho e de técnicas de cristalização para encontrar as distribuições de tamanho de partícula mais desejadas consistentemente a uma escala comercial.Para saber mais sobre nossas ofertas, favor ler a ficha técnica do Roxadustat ao preencher o formulário de contato abaixo.
Dr. Reddy’s Apremilast API e ofertas de formulações finalizadas.
Dr. Reddy’s é uma das indústrias farmacêuticas de API líderes em fornecer API de Apremilast globalmente, e levou o preenchimento USDMF em setembro 2016 (Forma-B) e junho de 2017 (Amorfo).Apremilast é um agente anti-inflamatório modulando uma ampla gama de mediadores inflamatórios em psoríase e artrite psoriásica. Apremilast é indicado para o tratamento de artrite psoriásica ativa e psoríase em placas moderada a severa.O API amorfo do Dr. Reddy’s foi com sucesso formulado em produtos de drogas por vários formuladores com estudos de bioequivalência de sucesso e subsequente preenchimento de dossiê.Para saber mais sobre nossos oferecimentos, favor ler a ficha técnica sobre Apremilast ao preencher o formulário de contato abaixo.
Dr. Reddy’s Fosaprepitant ofertas de API
Fosaprepitant é indicado para prevenir náusea aguda e tardia e vômitos associados a quimioterapia moderada ou altamente emetogênica combinada com outros agentes emetogênicos. O FDA dos EUA e EMA aprovaram fosaprepitant em 2008, e a PMDA em 2011. Em dezembro de 2020, isso corresponde a uma demanda de API de 500 kg por ano (IQVIA MAT).Nós oferecemos API estáveis e amorfos que preenchem requerimentos regulatóris globais e as necessidades de formulação de clientes. To know more about Dr. Reddy’s Fosaprepitant offerings Read the technical sheet on this topic by filling the contact form below.
Apixaban API – grânulos prontos-para-comprimir e formas finais de dosagem
Dr. Reddy’s está entre os primeiros produtores globais de API genéricos de API para Apixabana e submeteu o USDMF em setembro de 2015. Our customers have access to the high-quality API in customized particle sizes to facilitate formulation development.Apixaban é uma medicação anticoagulante aprovada sob o nome Eliquis na Europa em 2011, e nos EUA em 2012. Foi primeiro aprovada para reduzir o risco de AVC e embolia sistêmica em pacientes com fibrilação atrial não valvular.Leia a ficha técnica desse tópico preenchendo o formulário de contato abaixo.
Apalutamida API – uma atrativa oportunidade NCE-1 para companhias farmacêuticas genéricas
Câncer de próstata representa 7,3% de todos os casos de câncer incidentais diários, conforme estimado pelo Globocan 2020. A prevalência em 5 anos do câncer de próstata é estimada em 5 milhões mundialmente, tornando-o o segundo câncer mais comum em homens.Apalutamide é um inibidor de receptor de androgênico oral, não-esteroidal, de segunda geração que se tornou a primeira droga aprovada pelo FDA para pacientes com câncer de próstata não-metastáticos resistentes à castração. Recebeu aprovação adicional em 2019 para câncer de próstata metastático hormônio-sensitivo e em seus estudos fase 3 para câncer de próstata metastático hormônio-refratário.Nosso APIpermite que formuladores escolham uma entrada de mercado compatível com IP que atenda aos requisitos regulamentares.Os aspectos-chave da nossa oferta são: Para continuar lendo nosso relatório branco, favor preencher o formulário de contato abaixo
Formulações de Complexo de Ferro Coloidal –Entendendo e Desenvolvendo o Processo
Esse relatório branco descreve os desafios envolvidos no desenvolvimento de ferro-carboidrato complexos, incluindo os parâmetros requeridos para demonstrar equivalência físico-química e sumariza nossa experiência em endereçá-los. Complexos de ferro-carboidrato são híbridos de moléculas orgânicas e inorgânicas. Os principais elementos estruturais da molécula são arquitetados/governados pelas definidas unidades de operação de processos e materiais usados no processo. Qualquer variação sutil nas unidades de operação de processo pode alterar as características estruturais dos complexos ferro-carboidratoPara continuar lendo, favor preencher o formulário de contato abaixo.
Rivaroxaban do Dr. Reddy: Ofertas de cesta complete para API e formulações terminadas
Dr. Reddy’s está entre os primeiros genéricos API fabricantes globally para API de Rivaroxabana e submeteu o USDMF em março de 2014. Dr. Reddy’s O processo do Dr. Reddy envolve transformações químicas seletivas e eficientes que oferecem vantagens distintas para qualidade e manufaturabilidade. O processo elimina as potenciais impurezas formadas no processo, e pode ser robusta e seguramente operado em uma escala comercial.Em mercados selecionados, também podemos providenciar o produto de droga formulada de Rivaroxabana e vamos te apoiar em todos os aspectos regulatórios do depósito ao registro.Para saber mais sobre nossas ofertas de Rivaroxabana, leia a ficha técnica preenchendo o formulário de contato abaixo.
Oferta de API Mirabegron do Dr. Reddy nas formas alfa e amorfa
Leia nossa ficha técnica sobre Mirabegron API para ter uma noção de nossa abordagem sintética escalonável em várias etapas com caracterização analítica efetiva resultando em um API altamente puro. Dr. Reddy's está entre os primeiros genéricos API manufacturers globally and filed the USDMF for Mirabegron API (α-form) in June 2014.Também desenvolvemos uma forma amorfa de Mirabegron, que foi protocolada nos EUA em fevereiro de 2015.Leia a ficha técnica desse tópico preenchendo o formulário de contato abaixo.
Palbociclib – como a abordagem de um novo processo de desenvolvimento providencia vantagens IP
Esse relatório branco delineia como a abordagem de desenvolvimento holística do Dr. Reddy’s pode ajudar nossos parceiros de API em várias geografias a providenciar aos pacientes acesso precoce à alternativa genérica do Palbocicilb enquanto ganha ou mantém vantagens competitivas.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.Para continuar lendo nosso mais recente relatório branco por favor preencha o formulário de contato abaixo: :Você também pode explorar nossas ofertas de Palbocicilb API clicando no link abaixo: below:https://api.drreddys.com/product/pt-pt/palbociclib
API Elagolix do Dr. Reddy oferecendo vantagens a uma abordagem Qualidade por Design bem estruturada
A ficha técnica do produto Elagolix APIdescreve a Qualidade por Design (QbD) abordagem tomada pela equipe R&D do Dr. Reddy para desenvolver o produto.Como resultado, Dr. Reddy’s é um dos primeiros e poucos produtores de API genéricos no mundo a validar com sucesso o processo Elagolix API cedo e em escala comercial.Leia o relatório técnico desse tópico preenchendo o formulário de contato abaixo.Você também pode explorar nossas ofertas de Elagolix clicando no link abaixo:https://api.drreddys.com/pt-pt/product/elagolix-sodium
Sacubitril/Valsartana (LCZ696) – Trazendo mais uma vantagem através de ofertas de API inovadoras
Our team of process and analytical experts draw on their integrated understanding in both the development and manufacturing of the API and the formulation.Isso é de importância particular quando se trata da caracterização de um complexo molecular que é crítico para o desenvolvimento com sucesso de API e formulação. Essa visão holística também ajuda a entender melhor o impacto do processo de formulação na integridade molecular e estabilidade do produto. Como resultado, nosso desenvolvimento desse complexo supra molecular foi capaz de igualar as características da droga listada de referência (RLD).Leia o relatório técnico desse tópico preenchendo o formulário de contato abaixo.Você também pode explorar nossas ofertas de Sacubitril/Valsartana (LCZ696) clicando no link abaixo:https://api.drreddys.com/pt-pt/product/sacubitril-valsartan
Especialistas em Fluxo de Química do Dr. Reddy compartilham suas perspectivas no painel de discussão do Química Hoje
JJunho de 2020Especialistas em Química de Fluxo do Dr. Reddy, Srividya Ramakrishnan e Rakeshwar Bandichhor, recentemente participaram do painel de discussão do Química Hoje, onde eles compartilharam suas perspectivas sobre tecnologia de fluxo e seu potencial para se tornar uma alternativa de manufatura superior para a síntese complexa de Ingredientes Farmacêuticos Ativos (API).Por favor preencha o formulário de contate-nos abaixo para ler o artigo sobre esse tópicoA publicação complete está disponível no link abaixo:https://www.teknoscienze.com/tks_article/panel-discussion-on-flow-chemistry-3/
Um olhar mais próximo em como o Dr. Reddy’s cumpre os requerimentos regulatórios adstringentes de impurezas genotóxicas na Ranolazina
Impurezas genotóxicas (GTIs) têm recentemente desafiado a indústria farmacêutica devido à sua presença em um nível de partes por milhão (ppm) em produtos de drogas, especialmente em moléculas de alta dosagem como Ranolazine, , que tem uma dose diária prescrita máxima (MDD) de 2000 mg.Nesse relatório branco, nós falamos sobre os passos tomados por Dr. Reddy's durante a fase de desenvolvimento do produto para endereçar esse desafio desenhando o processo de tal maneira que esses PGIs / GTIs estão sob controle na abordagem de fabricação seguida pelo Dr. Reddy para Ranolazina..Leia o relatório técnico desse tópico preenchendo o formulário de contato abaixo.Você também pode explorar nossas ofertas de Ranolazina API clicando no link abaixo:https://api.drreddys.com/pt-pt/product/ranolazine
APIs de Famotoidina e Nizatidina: Controlados por NDMA, distribuição de partículas customizada, segurança em cadeia de suprimentos
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.Nossos API Tidina são usados por companhias de formulações na Europa, EUA, Japão, Oriente Médio e Pacífico Asiático.Manufaturados e controlados de acordo com os guidelines internacionais sobre impurezas de nitrosaminas, esses APIs estão disponíveis para distribuição em partículas de tamanho customizado para idealmente atingir suas necessidades de formulação.Leia a ficha técnica de Famotidine and Nizatidinepreenchendo o formulário de contato abaixo:Você também pode explorar nossas ofertas de Tidine API clicando nos links abaixo:Famotidina: https://api.drreddys.com/product/famotidineNizatidina: https://api.drreddys.com/product/nizatidine
Meeting the New Regulatory Requirements in Sartan API Production
Fabricantes de APIs agora são requeridos a revisar seus processos de manufatura e provar a ausência de impurezas de nitrosamina. Esse relatório branco delineia as regulações e um estudo de caso em como os API Sartan do Dr. Reddy (como Valsartana) já se adequam a requerimentos futuros.Você pode revisar nosso portfólio Sartan clicando nos seguintes links::Valsartan - https://api.drreddys.com/product/valsartanLosartan - https://api.drreddys.com/product/losartan-potassiumTelmisartanIrbesartan
API Manufacturing
Research & Development
Customer Service
Regulatory
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: [email protected]