We have a diverse scientific team with expertise to meet API and advanced intermediate needs centred on the rapid synthesis of supplies. Our project management and technical teams ensure a seamless technology transfer of processes, as projects advance from feasibility to DMF filing through complete process optimisation, process validations and stability program. We can optimise and develop robust and cost efficient processes for large scale manufacturing using environment friendly routes under GMP conditions with globally acceptable regulatory guidelines.
The combination of development experience, manufacturing infrastructure and regulatory expertise makes GVK BIO a preferred strategic partner for reliable, cost effective, long term contract manufacturing partners for APIs/advanced intermediates.
GVK BIO’s manufacturing facility has approvals from worldwide regulatory authorities like USFDA, EDQM, PMDA, MFDS 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