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Dr. Reddy’s API Research and Development Capabilities
As an industry-leading active pharma ingredient manufacturer and an active pharmaceutical ingredient supplier of generic APIs, Dr. Reddy’s is a partner for pharma companies in more than 80 countries. Our strong R&D 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. Furthermore, our pharma research and development expertise has enabled us to develop a strong portfolio in key therapy areas, including oncology, cardiovascular, central nervous system, gastrointestinal system, etc.
Our capabilities include contained (Highly potent APIs) and non-contained APIs at laboratory, pilot, and production scales. In addition, we have the expertise to perform standard chemical reactions, route scouting, pharmaceutical development and technology, optimization, QbD implementation, solid-state characterization, polymorph screening, chiral chemistry, biocatalysis, and chemo-catalysis.
Dedicated R&D Centers
Our API commercial production facilities are equipped with state-of-the-art equipment, incorporating years of process optimization, and are supported by multi-purpose plants for key starting materials and intermediates, with stringent quality control systems and extensive experience in regulatory procedures established marketing and distribution infrastructure.
Our exemplary R&D and regulatory compliance record of accomplishment is testimony to the fact that all our facilities are USFDA approved and major regulatory bodies such as WHO GMP, MHRA, EMA, TGA, ANVISA, PMDA, COFEPRIS, etc.
We have dedicated R&D centers for high potent APIs, complex APIs, prostaglandins, steroids, and synthetic and semi-synthetic products. Our R&D capabilities of innovative process development, cost-effective technology development, and stronghold on complex chemistry have helped us to become the partner of choice for global players in the industry.
R&D Operations Guided by Sustainability Framework
Since 2010, Dr. Reddy’s Laboratories Ltd has been committed to the UN Global Compact corporate responsibility initiative and its principles in the environment, Sustainability, and green chemistry. As an active pharmaceutical ingredient supplier our primary goal is to develop products that will provide a reliable supply of products of superior quality for the pharmaceutical industry. Also, we ensure that our APIs are produced using eco-friendly processes so that our customers can sustainably access our APIs.
Our R&D Capabilities - Complex API’s and Services Supporting Early Market Entries
Our R&D Centres are Equipped With:
- cGMP compliant isolator systems for high potent raw materials, intermediates charging, filtration and drying, dispensing, and packaging
- Protecting the environment, people, and product - Dr. Reddy’s can handle molecules of OEL up to 0.1 µg/m3.
- Our Team of R&D experts developed processes and analytical methods to avoid the presence of nitrosamine impurities, which are already suitable to confirm future requirements of the EMA (NDEA or NDMA limits of < 0.03 ppm).
- Our experienced team of API and formulation experts supports you beyond API supply, ensuring successful formulation.
- Quality by design (QbD) based development skills in chromatography.
- Effective API pharma manufacturing process development with high-quality standards to meet regulatory requirements.
- Different purification approaches impurity profiling and characterization to meet the standards of the RLD.
- Process optimization and robust process in pharmaceutical development and technology.
- Deep knowledge in downstream purification and isolation.
- Applications of PAT (Gradient with NIR based) during development for chromatography and lyophilization.
Going Beyond APIs with Generic Formulation Offerings to Complement Your Capabilities
Models of Collaboration:
To know more about our products or order a sample, meet with our product experts in one-on-one virtual sessions here. For details on the offer ability of products for your market of interest, please reach out to us at api@drreddys.com.
- Our capabilities include contained (Highly potent APIs) and non-contained APIs at laboratory, pilot and production scales. We have the expertise to perform standard chemical reactions, route scouting, process development and optimization, QbD implementation, solid state characterization, polymorph screening, chiral chemistry, biocatalysis and chemocatalysis.
- Complemented by a fully integrated expertise across key starting materials, intermediates, and APIs, we are able to accelerate the time to market for our customers.
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As an integrated HPAPI supplier, we have the best in class infrastructure and practices for R&D and cGMP manufacturing. We enable best safety, health and environmental practices through Occupational Exposure Band (OEB) and Occupational Exposure Limit (OEL) based controls for workers, material, machines and environment.
- We have expertise in complex multi-step carbohydrates involving linear and convergent synthesis.
- We also have the downstream capability to purify and isolate carbohydrates involving water soluble intermediates.
With a dedicated facility for human and veterinary steroids, we have expertise in multi-step reactions, multiple module manufacturing, availability of stainless steel, glass-lined and Hastelloy C® reactors.
