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
国別の要件がある場合は、お手伝いいたします。
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.
Related Products
Lenvatinib Mesylate(Form-C)
Anti-Cancer/ Oncology
Pazopanib
Anti-Cancer/ Oncology
Venetoclax
Anti-Cancer/ Oncology
Azacitidine
Anti-Cancer/ Oncology
Azacitidine
Anti-Cancer/ Oncology
FAQs
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.
-
With over decades of experience, Dr. Reddy's specializes in developing and manufacturing High Potent Active Pharmaceutical Ingredients (HPAPI).
-
Our manufacturing sites are complemented by our analytical cGMP labs for QC and QA.
-
Manufacturing plants are regularly inspected/audited by international regulatory authorities and numerous customers.
-
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.
-
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
免責事項
このウェブサイト上のいかなる情報も、製品またはサービスへの言及を含め、販売の申し出を構成するものではなく、販売の申し出を表すものと解釈されるものでもありません。有効な特許により保護されている製品は、商用目的で提供または提供されるものではありません。ただし、特定のケースでは、Dr. Reddy の独自の裁量により、現地の法的要件に従って、そのような製品の研究用数量が、規制免除が存在する場所に、インド特許法第 107A 条 (Bolar 免除) に基づく規制提出の目的で提供される場合があります。購入者は、それぞれの市場における特許シナリオを含む製品またはサービスについて独自の評価を行う必要があり、すべての特許関連法的責任を負うことになります。Dr. Reddy は、商品性、特定目的への適合性、および非侵害の保証を含むがこれらに限定されない、明示または黙示を問わずすべての保証を否認します。