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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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Access to our dedicated infrastructure for HPAPI development
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Industry-leading safety practices and containment control strategy in place
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cGMP manufacturing sites (OEL 0.1µg/m³) cover an extensive range of HPAPIs
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Manufacturing plants are regularly inspected/audited by international regulatory authorities and numerous customers
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Expertise in manufacturing complex APIs of various quantities (from gram to multi-kilogram)
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Our regulatory team can support you in all aspects of your global filings
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Our manufacturing sites are complemented by our analytical cGMP labs for QC and QA
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Experienced technical and cross-functional team in both discovery, development, and analytical research departments
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Extensive expertise in developing hundreds of complex pharmaceutical products
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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
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