Dr. Reddy's API Manufacturing Capabilities:
Dr. Reddy’s manufactures 250+ APIs across India, Mexico, and the UK, with eight USFDA-inspected cGMP facilities—six in India, one in Mexico, and one in the UK. All facilities comply with ICH Q7 guidelines and are regularly audited by global regulatory authorities including USFDA, EMA, ANVISA, PMDA, Health Canada, and others.
With 40+ years of technical leadership, we specialize in complex APIs such as steroids, peptides, long-chain molecules, and HPAPIs. Our R&D teams develop robust, scalable processes and support customers through dossier filings and commercialization worldwide.
Dr. Reddy’s API division is strategically working towards becoming the number one API company in the world by focusing on strong innovation, global footprint, and exceptional customer service. As one of the top API manufacturers in USA driven by consistency and the increasing need for good health, we are committed to improving access to our APIs across the United States.
Reliable, Sustainable Supply Chain
- Multi-sourced KSMs for supply resilience
- Stringent quality specifications and timely deliveries
- Capacity expansion to meet global demand for essential APIs
Dr. Reddy’s combines deep scientific expertise, global compliance, and sustainable manufacturing to be your trusted API partner.
40+ years of expertise
Leading supplier of APIs for more than 40 years Leading supplier of APIs for more than 40 years Leading supplier of APIs for more than 40 years.
Eight manufacturing facilities
We have eight commercial USFDA inspected API pharma plants/production units, of which six are in India and one in Mexico and the UK.
In-depth knowledge in handling complex peptides & high potent molecules
Our experienced technical and cross-functional team can quickly scale up and synthesize various peptides ranging from few grams to multi-kilogram levels. Dr. Reddy's can support your high potent APIs (HPAPI) development and manufacturing needs.
Safety and Compliance
All our plants are operated in accordance with cGMP (ICH Q7a) and are regularly inspected/audited by international authorities and agencies.
Manufacturing Locations
- Mirfield, UK
- Cuernavaca, Mexico
- CTO VI Vizag & CTO-SEZ Vizag
- CTO - I, II, III, Hyderabad
- CTO - V (Miryalaguda, Nalgonda)
Estamos aqui para ajudar, se tiver algum requisito específico do seu país.
Manufacturing Capabilities
- 250+ APIsss
- 4,100+ KL of reactor volumes.
- 1250+ Reactors including ~100+ reactors with containment across 4 sites (HPAI /Oncology/ steroids/prostaglandins).
- 5,000+ MT of Intermediates manufactured.
- 90% of our API pipeline is forward integrated to generic formulations.
- 100+ Commercial Molecules
- 50+ Pipeline molecules (Filed + under development).
- 2,100+ MT of APIs manufactured.
- Deep expertise in handing complex peptide molecules.
- Can handle molecules of OEL up to 0.1 µg/m3 by protecting environment, people & product.
Quality Control
Quality Control Policies
A key component in quality control in pharmaceutical industry is helping customers by providing a quality product. We achieve this by ensuring that all our facilities operate efficiently and to the latest quality, safety, and productivity standards.
At Dr. Reddy’s, quality control is central to our commitment to delivering safe, high-quality APIs. Our facilities operate under cGMP (ICH Q7) standards, ensuring global regulatory compliance and consistent product performance.
Advanced Analytical & Process Excellence
- Scalable manufacturing for consistent quality
- Robust analytical methods to eliminate nitrosamine and azido impurities
- Comprehensive impurity profiling, characterization, and control
- Use of advanced techniques to define chemical and physical attributes
- Efficient operations aligned with the latest quality, safety, and productivity standards
Quality Assurance
The pharmaceutical quality assurance (QA) team at Dr. Reddy’s continually monitors various facets of the quality management system. We are committed to maintaining highest quality standards in cGMP manufacturing through periodic reviews and continuous improvement of quality management system. All our manufacturing units have undergone multiple cGMP audits by various regulatory authorities, and numerous quality audits by various customers. As a result, our high-quality APIs meets all the formulation needs for various global markets.
Review Meetings for Quality Control
Dr. Reddy’s maintains a robust quality system through continuous monitoring, cross-functional audits, and harmonized procedures across all API manufacturing units. Every facility operates under cGMP (ICH Q7) and is regularly inspected by global regulatory authorities.
Recognized for our strong compliance record, we support customers with:
- DMF, CMC, IND, and NDA filings
- Deep experience with USFDA, EMA, WHO GMP, PMDA, KFDA, ANVISA, Health Canada, and more
Related Pages
R & D
Customer Service
Regulatory
Aviso legal
Nenhuma informação neste site, incluindo qualquer referência a qualquer produto ou serviço, constitui uma oferta de venda ou pode ser interpretada como representando uma oferta de venda. Produtos protegidos por patentes válidas não são oferecidos ou fornecidos para uso comercial. No entanto, em certos casos, a critério exclusivo do Dr. Reddy e sujeito a requisitos legais locais, as quantidades de pesquisa de tais produtos podem ser oferecidas para fins de submissões regulatórias sob a Seção 107A da Lei de Patentes da Índia (isenção Bolar), onde quer que tais isenções regulatórias existam. Os compradores devem fazer sua avaliação independente do produto ou serviço, incluindo o cenário de patentes em seus respectivos mercados e serão responsáveis por todas as responsabilidades relacionadas a patentes. O Dr. Reddy se isenta de todas as garantias, expressas ou implícitas, incluindo, entre outras, garantias de comercialização, adequação a uma finalidade específica e não violação.