GVK BIO offers long term Contract Manufacturing services right from strategic partnerships in development, validations, DMF filing and commercial manufacturing of Active Pharmaceutical Ingredients (APIs)/advanced intermediates to APIs.
We have flexible business models to support various client needs:
- Process optimisation, technology transfer, validations and DMF filing followed by manufacturing upon commercialization
- Technology absorption, validations, DMF filing support and Commercial manufacturing
- Technology absorption and commercial manufacturing
Our manufacturing expertise is designed to handle a wide range of operating conditions with flexible scales. Our commercial manufacturing facility is co-located with our pilot plant, providing end-to-end API solutions from feasibility phase in R&D to commercial launch. Our process development, technology transfer and commercial execution teams collaborate seamlessly to provide concept to commercialization timelines. GVK BIO’s manufacturing facility at Hyderabad has approvals from worldwide regulatory authorities like USFDA, EDQM, PMDA, KFDA and WHO. These accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners.