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vijaya.nuty@gvkbio.com
We offer 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:
A. Technology/Process development and technology transfer to customer (Contract development model)
B. Technology absorption from customer, validations, DMF filing support and Commercial manufacturing (Contract manufacturing model)
C. Technology development and validations, DMF filing support commercial manufacturing (Contract development and manufacturing model)
We have a diverse scientific team with expertise to meet API and advanced intermediate needs centered 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 optimization, process validations and stability program. We can optimize and develop robust and cost efficient processes for large scale manufacturing using environment friendly routes under GMP conditions with globally acceptable regulatory guidelines.
We have also commissioned new high potent R&D lab and manufacturing facility at our Hyderabad facility to manufacture highly potent materials (high-potency advance Intermediates & APIs );
• HP API facility is part of approved GMP location (USFDA,UGMP, kFDA and PMDA approved) it is having facilities to manufacture 0.1 kg to 5 kg scale production.
We have dedicated R&D labs for developing HP molecules.
• Use our standalone Analytical facility (GLP facility) for API`s and Formulations Analytical support
Our manufacturing facility has approvals from worldwide regulatory authorities like below and these accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners.
a) In rare instance a joint
bruce@senovatech.com
kindly send your requirements to my email below and we will submit our quote.
bruce@senovatech.com
