With over decades of experience, Dr. Reddy's specializes in developing and manufacturing High Potent Active Pharmaceutical Ingredients (HPAPI). We offer HPAPIs manufactured in our FDA inspected cGMP API manufacturing facilities with comprehensive containment processes (up to OEL 0.1µg/m³) and diligent QC/QA.
Reddy’s approach for high-potent APIs involves the following process:
01.Evaluating the hazard of exposure to a compound and calculating the OEL levels
02.Selecting the appropriate containment strategy for development and manufacturing based on scale
03.Choosing proper engineering controls such as ventilation, chemical contaminants, etc.
04.Selecting the appropriate equipment and procedures, including PPE Sampling & weighing, blending, and drying
05.Define Packaging needs to meet the requirements Capsule/Blistering Injectables
From initial stages of development to commercialization, our team of scientists, quality, regulatory, supply chain, and analytical experts work collaboratively to meet our global clients' HPAPI requirements.
As an integrated HPAPI supplier, we have best-in-class cGMP manufacturing facilities for APIs and finished dosage forms. With our integrated R&D capabilities and infrastructure, we are well-positioned to support our customers to bring their products to the market faster. In addition, our rigorous safety, health, and environmental (SHE) practices, together with Occupational Exposure Band (OEB) and Occupational Exposure Limit (OEL) based controls, are established to protect workers, materials, machines, and the environment.
Dr. Reddy’s can handle molecules of OEL up to 0.1 µg/m3 at the following facilities:
Access to our dedicated infrastructure for HPAPI development
Industry-leading safety practices and containment control strategy in place
cGMP manufacturing sites (OEL 0.1µg/m³) cover an extensive range of HPAPIs
Manufacturing plants are regularly inspected/audited by international regulatory authorities and numerous customers
Expertise in manufacturing complex APIs of various quantities (from gram to multi-kilogram)
Our regulatory team can support you in all aspects of your global filings
Our manufacturing sites are complemented by our analytical cGMP labs for QC and QA
Experienced technical and cross-functional team in both discovery, development, and analytical research departments
Extensive expertise in developing hundreds of complex pharmaceutical products
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Top-class safety practices and containment control strategy in place.