First Time US Generics (FTUG) develops, tests, manufactures and helps commercialize generic pharmaceutical products, taking projects from formulation through regulatory approval and launch. Unlike a typical contract research or manufacturing organization, FTUG combines product development with US- and EU-focused regulatory consulting and generic-drug patent support. Its 5,000-square-foot testing and development facility in Navi Mumbai extends the company’s work into Asia, while its Philadelphia manufacturing facility operates in an FDA- and EMA-compliant environment.
21 CFR 210 and 211 compliance
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ICH cGMP compliance
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EMA and FDA GMP compliance
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DEA licensed
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