Megafine, established in 1995, is a privately owned and professionally managed enterprise with it’s corporate office in Mumbai, India and two multipurpose manufacturing sites at Vapi & Nashik in India, both successfully inspected by US-FDA. With it’s decades of experience in the Pharmaceutical Industry, Megafine not only manufactures it’s own Active Pharmaceutical Ingredients (APIs) and Advanced I
ntermediates but also Contract manufactures for Innovators and several Global Pharma companies. Our partners are essentially innovators and generic drug companies across the globe for whom we develop a range of new niche products in select therapeutic categories like CNS (Central Nervous System), Anthelmintic and Urinary Incontinence. We supply a wide range of high quality generic and custom manufactured APIs in volumes that range from a few grams to tons. Megafine has a special expertise in Polymorphs and Chiral products. Megafine is also one of the largest manufacturers of Pyrantel Pamoate besides being a leading manufacturer of Piperazine derivatives. Both the plants are successfully US-FDA inspected as well as certified by Japanese PMDA, WHO GMP, ISO 9001:2008, 14001:2004 & OHSAS 18001:2007 and have been audited by several Innovators and leading Generic companies from time to time. A perfect blend of Human talent, R&D Labs, Pilot Plant & cGMP manufacturing facilities backed by our Quality Assurance, Regulatory Affairs and Intellectual Property cell gives Megafine an edge. Our regulatory team is well trained & experienced to comply with US-FDA, EDQM, Japanese PMDA & other regulatory authority requirements. The company has over 40 regulatory filings for it’s APIs to it’s credit with an impressive pipeline.
