Meet with our product experts in one-on-one virtual sessions
Set Up a Meeting
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
Contact Us
Please fill out the following form. We will get back to you shortly.
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
Renuncia
Ninguna información en este catálogo, incluida cualquier referencia a cualquier producto o servicio, constituye una oferta de venta, ni debe interpretarse como representación de una oferta de venta. Los productos protegidos por patentes válidas no se ofrecen ni se suministran para uso comercial. Sin embargo, las cantidades de investigación de dichos productos pueden ofrecerse con el fin de presentaciones reglamentarias, siempre que existan dichas exenciones reglamentarias. Los compradores deben realizar una evaluación independiente del escenario de la patente para sus respectivos mercados y serán responsables de todas las responsabilidades relacionadas con la patente. Los productos protegidos por patentes válidas en la India no están disponibles para uso comercial, pero estarían disponibles para los fines de la Sección 107A.
Have you booked your
CPHI Japan meeting slot yet?
Join us at booth: 5N-12
17th-19th April 2024
East Halls 4, 5 & 6, Tokyo Big Sight, Tokyo, Japan