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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
Oct 7, 2021
2021年美国制造业最佳印度公司的获胜者
Oct 6, 2021
舒更葡糖钠原料药 - 巴西卫生监督局批准的原料药档案适当性函
May 27, 2021
迪帕克•萨普拉谈到了印度国防研究与发展组织的抗新冠病毒药物2DG
Jan 21, 2021
2021年度制药行业最佳供应链团队
Oct 13, 2020
世界医药原料展制药节圆桌会议： 解决亚硝胺污染问题
Oct 5, 2020
瑞迪博士的实验室加入了科学基础目标计划（SBTi），制定了2030年的温室气体排放目标
Apr 14, 2020
瑞迪博士关于新冠病毒病大流行的报告
Mar 1, 2020
阿帕鲁胺的美国药物主文件 - 现已可用
Mar 1, 2020
瑞迪博士2018-19年可持续发展报告
Dec 1, 2019
瑞迪博士的原料药团队搬进其在中国的新办公室
Nov 1, 2019
瑞迪博士的实验室在2019年全球仿制药和生物仿制药奖上获得“年度原料药供应商”奖
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 [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.
瑞德西韦（Remdesivir）系由瑞迪博士（Dr.Reddy’s）在吉利德（Gilead）许可下研发：
瑞德西韦是美国食品和药物管理局（FDA）批准的首种治疗新冠病毒病（COVID-19）的药物，用于需要住院治疗的成人和儿童患者（12岁或以上，体重至少40公斤）。它是新冠病毒RNA依赖的RNA聚合酶（RdRp）的抑制剂，对病毒的复制至关重要。除了美国食品和药物管理局，瑞德西韦已被多个监管机构授权紧急使用于治疗新冠病毒病，包括EMA（欧洲药品管理局）、MHLW（日本厚生劳动省）、PMDA（日本独立行政法人医药品及医疗器械综合管理机构药品和医疗设备机构）和CDSCO（印度中央药品标准控制组织）。要了解更多关于我们的产品，请填写联系表，阅读关于瑞德西韦 的白皮书
白皮书： 瑞迪博士的2 DG - 一种对住院的新冠病毒病患者来极具前景的治疗方法
2-脱氧- D -葡萄糖（2-DG）是印度国防研究与发展组织（DRDO）核医学与有关科学研究所（INMAS）开发的一种抗病毒和抗炎药物。瑞迪博士与印度国防研究与发展组织合作，对新冠病毒病患者进行了2-DG的临床试验。基于印度的II期和III期研究，2-DG已获得紧急使用授权，可用作医院中度至重度新冠病毒病患者的辅助治疗。瑞迪博士是首家成功为新冠病毒病患者提供2-DG的公司。因此，我们能够让客户提早获得针对特定市场的原料药（API）和成品处方。想知道更多？please fill in the contact details to read the whitepaper on our 2 DG API and finished product offerings.
技术表： 瑞迪博士的乐伐替尼（Lenvatinib）原料药产品
乐伐替尼是一种口服酪氨酸激酶抑制剂，可用于多种适应症，包括分化型甲状腺癌、肾细胞癌、肝细胞癌和子宫内膜癌。我们提供两种多晶型：1)甲磺酸乐伐替尼甲基异丁酮溶剂2)甲磺酸乐伐替尼C型。甲基异丁酮溶剂是一种新晶型，在多个市场上提供了比多晶型专利更早推出的优势。美国食品和药物管理局已经为以下两种晶型提交了申请：* 甲磺酸乐伐替尼甲基异丁酮溶剂，2018年6月。* 无水甲磺酸乐伐替尼C型，2021年6月。我们有能力满足全球对乐伐替尼原料药, 的需求，并能够在有需要时扩大规模以满足商业需求。 想了解更多有关我们原料药产品的信息，请填写下面的联系方式。
罗沙司他（ROXADUSTAT）- 多管齐下的发展战略
在本白皮书中，我们概述了罗沙司他的各种发展战略如何在2020年3月成功填补美国药物主文件（USDMF），以助我们的跨地区合作伙伴为患者提供早期治疗。罗沙司他属首创新药，是小分子口服缺氧诱导因子脯氨酸羟化酶抑制剂（HIF-PHI），可增加内源性促红细胞生成素的产生，从而刺激血红蛋白和红细胞的产生。这种创新的方法在治疗慢性肾脏疾病（CKD）贫血患者方面取得了突破。我们可以通过粒径减小和结晶技术来满足定制的粒径分布要求，以在商业规模上始终如一地满足最理想的粒径分布。想了解更多关于我们产品的信息，请填写下面的联系表，阅读罗沙司他 阅读罗沙司他的技术表。
瑞迪博士的阿普斯特片（Apremilast）原料药和成品配方产品。
Dr. Reddy's is one of the leading API pharma companies supplying Apremilast API globally, and has led the USDMF filing in September (Form-B) and June 2017 (Amorphous).阿普斯特片是一种抗炎药，在银屑病和银屑病关节炎中调节广泛的炎症介质。阿普斯特片适用于活动性银屑病关节炎和中度至重度斑块型银屑病。瑞迪博士的无定形原料药（API）已通过成功的生物等效性研究和随后的档案归档，成功地由多个配方商配制成药品。想了解更多关于我们产品的信息，请填写下面的联系表，阅读阿普斯特片的技术表。
瑞迪博士的福沙吡坦（Fosaprepitant）原料药产品
福沙吡坦用于预防中度或高度致吐性化疗以及其他止吐药物引起的急性和迟发性恶心和呕吐。美国食品及药物管理局和欧洲药品管理局于2008年批准福沙吡坦，而日本独立行政法人医药品及医疗器械综合管理机构药品和医疗设备机构于2011年批准福沙吡坦。截至2020年12月，这相当于原料药每年500公斤的需求量（IQVIA MAT）。我们提供稳定的非晶型原料药，能够满足全球法规的要求和客户的配方需求。To know more about Dr. Reddy’s Fosaprepitant offerings Read the technical sheet on this topic by filling the contact form below.
阿哌沙班（Apixaban）原料药 - 易压缩颗粒和成品剂型
瑞迪博士是全球最早的阿哌沙班原料药仿制药生产商之一，并于2015年9月进行了美国药物主文件备案。我们的客户可以获得定制粒径的高质量原料药，以促进配方开发。阿哌沙班是一种抗凝血药物，于2011年在欧洲以艾乐妥（Eliquis）为商号获得批准，并于2012年在美国获得批准。 它最初经批准用于降低非瓣膜性心房颤动患者中风和全身性栓塞的风险。填写下面的联系表，阅读相关技术表。 探索其他白皮书：了解更多
阿帕鲁胺（Apalutamide）原料药 - 对仿制药公司极具吸引力的NCE-1机遇
根据全球癌症统计报告2020年版（Globocan 2020）发布的估算，前列腺癌占了全球所有癌症病例的7.3%。 据估计，前列腺癌在世界范围内的5年患病率约为500万，使其成为男性中第二常见的癌症。阿帕鲁胺是一种口服二代非甾体雄激素受体抑制剂，并成为美国食品及药物管理局批准的首个用于非转移性去势抵抗性前列腺癌患者的药物。该药物于2019年获得额外批准，用于治疗转移性激素敏感性前列腺癌，目前正处于转移性激素难治性前列腺癌的3期临床试验。我们的API原料药允许配方商选择符合知识产权的市场准入，并满足监管要求。 我们提供的产品主要包括： 如果想继续阅读我们的白皮书，请填写下面的联系表 探索其他白皮书：了解更多
胶体铁络合物（Colloidal Iron Complex）配方 - 认识和发展流程
本白皮书描述了发展 铁碳水化合物 复合体所涉及的挑战, 包括证明物理化学等效性所需的参数，并总结了我们在解决这些问题方面的专业知识。 铁碳水化合物是无机和有机分子的混合物。 分子的关键结构元素是由确定的流程单元操作和流程中使用的材料进行构建/支配的。 流程单元操作中的任何细微变化都能改变铁碳水化合物的结构特征想继续阅读，请填写以下联系表
瑞迪博士的利伐沙班（Rivaroxaban）： 完整的原料药和成品配方产品
雷迪博士是最早的仿制药之一 原料药制造商 全球为 利伐沙班 API 并于 2014 年 3 月提交了 USDMF。 雷迪博士的 过程涉及选择性和有效的化学转化，为质量和可制造性提供独特的优势。该过程消除了过程中形成的潜在杂质，并且可以在商业规模上稳健且安全地运行。在选定的市场，我们还可以提供利伐沙班的制剂产品，并将在从申请到注册的所有监管方面为您提供支持。要了解有关我们的利伐沙班产品的更多信息，请填写下面的联系表，阅读技术表。
瑞迪博士提供的阿尔法型和非晶型（Mirabegron） 原料药
通读我们的技术表 米拉贝隆 API了解我们的多步可扩展合成方法以及有效的分析表征，从而获得高纯度的 API。 Dr. Reddy's 是最早的仿制药之一 全球 API 制造商 并为 Mirabegron API 提交了 USDMF(α-form) 于 2014 年 6 月。我们还开发了 Mirabegron 的无定形形式，已于 2015 年 2 月在美国提交申请。通过填写下面的联系表阅读有关此主题的技术表。
帕博西尼（Palbociclib） - 新流程开发方法如何提供知识产权优势
本白皮书概述了 Reddy 博士的整体开发方法如何帮助我们跨地区的 API 合作伙伴为患者提供早期使用的通用替代方案 帕博西尼 同时获得或保持竞争优势。我们的工艺专家团队利用他们对知识产权、工艺开发（API 和配方）的综合理解，以及 原料药制造 确保通过设计该过程是精益的，没有潜在的遗传毒性杂质和 可扩展以制造早期市场进入。要继续阅读我们最新的白皮书，请填写以下联系表格：您还可以通过单击下面的链接 探索我们的 Palbocicilb API 产品https://api.drreddys.com/zh-hans/product/palbociclib
瑞迪博士的恶拉戈利（Elagolix ）原料药提供了全面的质量源于设计方法
我们的技术产品表 Elagolix API 描述了 质量源于设计 (QbD) Dr. Reddy's R& 采用的方法amp;D 团队开发产品。因此，Dr. Reddy's 是第一个也是少数几个通用 API 世界上的制造商在早期和商业规模上成功地验证了 Elagolix API 工艺。通过填写下面的联系表阅读有关此主题的技术表。您还可以通过单击以下链接探索我们的 Elagolix 产品：https://api.drreddys.com/zh-hans/product/elagolix-sodium
沙库必曲/缬沙坦（Sacubitril/Valsartan）（LCZ696） - 通过创新的原料药产品带来另一个优势
我们的过程和分析专家团队利用他们对开发和分析的综合理解API的制造 和配方。当涉及到对成功的关键分子复合物的表征时，这一点尤为重要 API 和配方开发。这种整体观点也有助于更好地了解配方过程对产品分子完整性和稳定性的影响。因此，我们开发的这种超分子复合物能够与参考上市药物 (RLD) 的特征相匹配。填写下面的联系表格，阅读我们关于此主题的最新白皮书。您还可以探索我们的 Sacubitril/Valsartan (LCZ696) 产品 通过点击链接 以下：https://api.drreddys.com/zh-hans/product/sacubitril-valsartan
瑞迪博士流动化学专家在《今日化学》（Chemistry Today）小组讨论会上分享了他们的观点
2020 年 6 月Reddy 博士的流动化学专家 Srividya Ramakrishnan 和 Rakeshwar Bandichhor 最近参加了“今日化学”的小组讨论，他们在会上分享了他们对流动技术及其成为复杂合成的卓越制造替代品的潜力的看法 活性药物成分 (API).请填写下面的联系我们表格以阅读有关此主题的文章。完整的出版物可在以下链接中找到：https://www.teknoscienze.com/tks_article/panel-discussion-on-flow-chemistry-3/
进一步了解瑞迪博士如何满足雷诺嗪（Ranolazine）中基因毒性杂质的严格监管要求
基因毒性杂质 (GTI) 最近对制药业提出了挑战，因为它们在药品中的含量达到百万分之几 (ppm)，尤其是在高剂量分子中，如 雷诺嗪，其规定的最大每日剂量 (MDD) 为 2000 毫克。在本白皮书中，我们讨论了由 雷迪博士的 在产品开发阶段应对这一挑战 通过以这样一种方式设计工艺，使所有这些 PGI / GTI 都在制造方法的控制范围内，然后是 Reddy 博士的雷诺嗪。填写下面的联系表格，阅读我们关于此主题的最新白皮书。您还可以通过单击链接探索我们的雷诺嗪 API 产品 以下：https://api.drreddys.com/zh-hans/product/ranolazine
法莫替丁（Famotidine）和尼扎替丁（Nizatidine）原料药： 受控的亚硝基二甲胺（NDMA），定制的颗粒分布，安全的供应链
20多年来，瑞迪博士一直是H2受体拮抗剂原料药（如法莫替丁和尼扎替丁）的最大制造商之一。 欧洲、美国、日本、中东和亚太地区的配方公司都在使用我们的替丁（Tidine）原料药。这些 API 根据亚硝胺杂质的国际指南制造和控制，可提供定制的粒度分布，以理想地满足您的配方需求。阅读技术表法莫替丁 and 尼扎替丁 通过填写下面的联系表格。您还可以通过单击以下链接探索我们的 Tidine API 产品：法莫替丁： https://api.drreddys.com/product/famotidine尼扎替丁： https://api.drreddys.com/product/nizatidine
满足沙坦（Sartan）原料药生产的新法规要求
原料药制造商 现在被要求审查其生产流程，并证明不含亚硝胺杂质。这份白皮书概述了相关法规和瑞迪博士的 Sartan 沙坦原料药（如缬沙坦（Valsartan））如何满足未来需求的案例研究。您可以通过点击以下链接查看我们的沙坦系列产品：:缬沙坦 - https://api.drreddys.com/product/valsartan洛沙坦 - https://api.drreddys.com/product/losartan-potassium替米沙坦厄贝沙坦
API Manufacturing
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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: [email protected]