Megafine Pharma (P) Ltd

Megafine, established in 1995, is a privately owned and professionally managed enterprise with it’s corporate office in Mumbai and two multipurpose manufacturing sites at Vapi & Nashik in India, Vapi facility being successfully inspected by US-FDA i facility being successfully inspected by US-FDA and the Nashik facility is being approved by BGVFHH Germany (EMA EU-GMP), Japan PMDA, Health Canada, TGA Australia, COFEPRIS Mexico & Korea MFDS. Both the plants are also certified by 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. Megafine provides innovative & integrated API solutions with it’s decades of experience and skill in the development of novel chemical processes catering to the global drug discovery and generic companies. Our continuous investment in research and development generates a steady flow of APIs enabling timely introduction of new products in the market. Megafine is committed to respecting third party intellectual property rights, manufacture products which are commercially competitive and meet the most stringent quality standards. Besides manufacturing its own Active Pharmaceutical Ingredients (APIs) & Advanced Intermediates, we also contract manufacture for global drug discovery and generic companies. Our focus is on niche products; with a presence in more than 40 countries. Our partners are essentially drug discovery and generic drug companies across the globe for whom we develop a range of new niche products in select therapeutic categories like Anthelmintic, Cardiology, Urinary Incontinence, CNS (Central Nervous System), & a few others. 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 special expertise in Polymorphs and Chiral products. 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 150 regulatory filings across the globe for its APIs to its credit with an impressive pipeline. To become a valued and preferred partner to the global healthcare industry To be a dependable manufacturer and supplier of APIs and Advance intermediates to the Global Pharma industry, by offering innovative and integrated API solutions, in a timely manner ...view more