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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
We are here to help, if you have any country specific requirements.
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.
Facilities for handling HPAPIs
Dr. Reddy’s can handle molecules of OEL up to 0.1 µg/m3 at the following facilities:
- cGMP compliant isolator systems (OEL 0.1µg/m³) for high potent raw materials, intermediates charging, filtration and drying, dispensing and packaging
- Reaction mass transfer through closed loop lines
- Rapid transfer ports for solid material transfer
- HVAC system with zone classification to avoid cross-contamination
- EPA filtered air
- Multiple utilities (cooling tower water, hot water, chilled brine, nitrogen, compressed air & steam
- Differential pressure system with temperature and humidity control
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Top-class safety practices and containment control strategy in place.
- HVAC system with zone classification to avoid cross-contamination
- Choosing proper engineering controls such as ventilation, chemical contaminants, etc
Disclaimer
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.