GVK BIO’s manufacturing facility has approvals from worldwide regulatory authorities like USFDA, EDQM, PMDA, KFDA and WHO GMP. These accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners.
GVK BIO’s manufacturing team has expertise to handle a wide range of operating conditions with flexible scales. Over the years we have exhibited exemplary process and technology capabilities for NCEs and commercial production of advanced intermediates/APIs. Our process development, technology transfer and commercial execution teams collaborate seamlessly to provide best-in-class concept to commercialisation timelines.
- Driven by the need to design an economic and robust process with defined in-process controls to yield optimum and desired quality
- Provide engineering support from initial stages of product development by identifying process specific facility requirements to deliver a validated process at designated scale
- Observe and assimilate process operations and all critical parameters and systematically execute under guidelines charted by Quality Management Systems
- GMP compliant six manufacturing blocks with varied capacities ranging from 20 L – 6,000 L
- Total reaction volume capacity: 170,000 L
- MOC: All glass, glass lined, SS & Hastelloy reactors
- Hydrogenation capabilities: 50 L to 2,000 L, upto 25 bar and large scale column chromatography
- Class 100,000 cleanroom, kilo labs and powder processing area
- Stability chambers for conducting stability studies at all conditions