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About Megafine Pharma (P) Ltd. in Sethna, 4th Floor, 55 Maharshi Karve Road, Marine Lines,, Mumbai
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 Intermediates but also Contract manufactures for Innovators and several Global Pharma companies.Our focus is on niche products with a presence in more than 40 countries. 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.
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