High Potent Active Pharmaceutical Ingredients(HPAPI) Manufacturing

Soluções API

Dr. Reddy's API business supplies high-quality, affordable APIs to leading generic formulations manufacturers and is the preferred API partner for pharma companies in more than 100 countries.

R&D

Dr. Reddy’s supplies generic APIs to 80+ countries, excelling in R\&D across niche molecules and key therapies, with capabilities from lab to production in contained/non-contained APIs and advanced chemical processes.

Livro Branco

Dr. Reddy’s offers insightful whitepapers sharing expertise on APIs, formulations, regulatory trends, and industry innovations, helping global pharma partners gain knowledge, solve challenges, and drive faster, compliant product development.

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:

Evaluating the hazard of exposure to a compound and calculating the OEL levels

Selecting the appropriate containment strategy for development and manufacturing based on scale

Choosing proper engineering controls such as ventilation, chemical contaminants, etc.

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

Selecting the appropriate equipment and procedures, including PPE Sampling & weighing, blending, and drying

Define Packaging needs to meet the requirements Capsule/Blistering Injectables

Estamos aqui para ajudar, se tiver algum requisito específico do seu país.

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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FAQs

What is the minimum OEL that Dr. Reddy's can handle?

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.

What experience does Dr. Reddy's have in producing HPAPIs?

With over decades of experience, Dr. Reddy's specializes in developing and manufacturing High Potent Active Pharmaceutical Ingredients (HPAPI).

What are our Quality Control (QC) capabilities for HPAPIs Manufacturing?

Our manufacturing sites are complemented by our analytical cGMP labs for QC and QA.

How do FDA or regulatory authorities inspect our HPAPIs?

Manufacturing plants are regularly inspected/audited by international regulatory authorities and numerous customers.

What factors are involved in the safety scale-up synthesis of an HPAPI drug substance in Dr. Reddy's?

We enable the best safety and healthy environmental practices through Occupational Exposure Band (OEB) and Occupational Exposure Limit (OEL) based controls for workers, material, machines, and environment.

What is the containment strategy performed for HPAPIs in Dr. Reddy's?

Top-class safety practices and containment control strategy in place.
1. HVAC system with zone classification to avoid cross-contamination
2. Choosing proper engineering controls such as ventilation, chemical contaminants, etc

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Soluções API

R&D

Livro Branco

High Potent Active Pharmaceutical Ingredients(HPAPI) Manufacturing

Dr. Reddy’s Approach in Handling HPAPIs

Estamos aqui para ajudar, se tiver algum requisito específico do seu país.

Facilities for handling HPAPIs

Contact Us

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