Sun’s Key Halol Plant Flunks FDA Inspection Again
The US FDA has flagged more issues at Indian firm Sun Pharma’s largest manufacturing plant in Halol but analysts are hoping the infractions are minor and that the Indian facility will get the regulatory green light soon, ending a blacklist on the factory supplying new products to the US.
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Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Sun Pharma, India's top-ranked drug firm, has three key specialty launches lined up in the US in FY19. Management commentary was generally upbeat about the potential prospects of the three products, but also emphasized that the commercialization plans will entail significant costs.
The latest drug development news and highlights from our US FDA Performance Tracker.