High Potent Active Pharmaceutical Ingredients(HPAPI) Manufacturing

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.

Dr. Reddy’s Approach in Handling HPAPIs

Reddy’s approach for high-potent APIs involves the following process:

Dr. Reddy’s
Approach in
Handling
HPAPIs

 

 

 

 

 

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.