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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
8 Manufacturing
Sites
More than 1880 drug master files
across global markets
50+ Pipeline molecules
(Filed + under development)
State-of-the-art R&D centers
in India, U.K., U.S. & Netherlands
Over 1300+ research scientists
working on various projects
Our Achievements
11/11/2021
Dr. Reddy's API team is a 2021 winner in - API Supplier of the year at Global generics & Biosimilars awards
11/11/2021
The winner of the Corporate social responsibility (CSR) Initiative of the year at Global generics & Biosimilars Awards
10/11/2021
Dr. Reddy's at CPHI 2021
21/01/2021
Best Supply Chain Team of the Year - Pharma- 2021
03/11/2020
Dr. Reddy’s Laboratories wins “API Supplier of the Year” award at the Global Generics & Biosimilars Awards 2020
19/10/2020
Dr. Reddy's recognized at the CPhI Pharma Awards 2020 as the winner in the category of 'Excellence in Pharma: Sustainability'
Resources
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 pro
CAS no. 223673-61-8 Mirabegron 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, suc
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 Caboz
Dr. Reddy's Offerings: USDMF filed in februray 2024 Offers crystalline innovator form. Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are activel
Dr. Reddy's Offerings*: Planning USDMF by January 2025 Offers crystalline Form-1 Non-GMP API and COA are available. Quality Assurance through cGMP API Manufacturing Manufact
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
CAS No: 737789-87-6 As 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. Ou
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)
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 ulce
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
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 gr
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 typ
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 o
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. Thi
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
CAS no. 1642288-47-8 Mavacamten (Camzyos®) is the pioneering and singularly authorised cardiac myosin inhibitor designed to address hypertrophic cardiomyopathy (HCM) at its root cause. This un
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 pro
CAS no. 1609392-27-9 Dr. Reddy's API Offering We are targeting crystalline Form and working on other amorphous solid dispersions (ASDs) as well. Our API adheres to ICH M7 guidelines for ge
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, thereb
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 leu
Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine Hydrochloride is indicated for:
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
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 c
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 cy
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. Bempe
Lumateperone is a serotonin 5HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM), and a serotonin transporter (SERT) inhibitor. Unlike existing schizophrenia treatments,
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 therap
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 azi
Voriconazole (Vfend®) is an azole antifungal indicated for invasive aspergillosis candidemia (non- neutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds, an
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).
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.
Remdesivir is the First treatment approved by the US FDA for the treatment of COVID-19 in adult and paediatric patients (12 years or older, and weighing at least 40 kg) that require hospitalization.
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. Abir
Gemcitabine Hydrochloride is an analog of the antimetabolite nucleoside deoxycytidine with antineoplastic activity. Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycyti
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.
Research & Development
We have development facilities in Hyderabad, India, and Cambridge, UK, as well as cGMP API manufacturing facilities in India, Mexico, and the UK. Our strong capabilities in synthetic chemistry, analytical chemistry, and process engineering have helped us build a strong portfolio of small molecule APIs across niche areas, including peptides, carbohydrates, prostaglandins, steroids, and highly potent APIs, making us top active pharmaceutical ingredient manufacturers in USA and API suppliers in India. In addition, this expertise has enabled us to develop a strong portfolio and API producers in key therapy areas including oncology, cardiovascular and central nervous system. Our capabilities include complex chemical synthesis, HPAPIs, peptides, carbohydrates, and steroids.
Customer Service
Dr. Reddys provides its customers with a superior service experience with an XCEED platform. XCEED will help manage the whole business process in real time. From ordering samples to submitting and tracking their orders, XCEED provides convenience and transparency by providing a platform to interact with Dr. Reddy's interdisciplinary support team, which helps in the timely delivery of the APIs closely.
Regulatory
Dr. Reddy’s has unmatched global regulatory expertise focused on international markets. Our top-class quality and industry-leading compliance are designed to ensure our products meet stringent requirements globally. As an active pharmaceutical ingredient manufacturer, our regulatory affairs (RA) team is one of the strongest in the industry and top API pharma companies, with a dedicated team of more than 50+ experts in regulatory affairs. Our team of regulatory experts understands the complex issues associated with regulatory agencies and assists in approving each complex API by analyzing the latest regulatory trends and quality requirements through active monitoring and proactive assessment of potential risks and enabling early launch advantages.
Dr. Reddy's API supplies high-quality, affordable APIs to leading generic formulations manufacturers and is the preferred API supplier to pharma companies worldwide. Dr. Reddy's API business thrives on the deep technical strengths proven over the last three decades in developing and manufacturing complex APIs.
The API division is strategically working towards becoming the number one API manufacturing companies in the world by focusing on solid innovation, global footprint, and exceptional customer service.
Selecting a world-class API and active pharmaceutical ingredient manufacturer is one of the most critical decisions a pharmaceutical manufacturer will make. So, choose your API wisely from the largest API manufacturers in India. To know more about the portfolio of our APIs and its services, place a query or contact our team at: api@drreddys.com
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