Selexipag

Company Description:
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, both successfully inspected by US-FDA & the Nashik facility is also approved by EMEA, PMDA & KFDA & COFEPRIS. 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.</p>
<p>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.</p>
<p>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.</p>
<p>Megafine has special expertise in Polymorphs and Chiral products.</p>
<p>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.</p>
<p>Our regulatory team is well trained & experienced to comply with US-FDA, EDQM, Japanese PMDA & other regulatory authority requirements. The company has over 250 regulatory filings across the globe for its APIs to its credit with an impressive pipeline.