India Pharma Outlook Team | Monday, 22 September 2025
Indoco Remedies Limited has announced that the US FDA inspected its Active Pharmaceutical Ingredients (API) manufacturing facility at Patalganga, Navi Mumbai and has concluded with zero Form 483 observations.
This is evidence of Indoco's commitment to the highest standards of quality, compliance and operational excellence.
Commenting on the development, Aditi Panandikar, Managing Director of Indoco Remedies, said, “This successful USFDA inspection is a testament to the strong quality culture and compliance in every process and every product. We remain committed to strengthening our systems to deliver safe and efficacious medicines across the globe.”
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In this way Indoco continues to enhance its trustworthiness as a pharmaceutical partner in regulated markets. Indoco is a fully integrated, research based pharmaceutical company with a global presence of $180 million/year, with over 6000 employees and 400 scientists contributing every day to innovation and the growth of Indoco's product offerings through 11 manufacturing facilities, of which 7 are formulations (FDFs) and 4 are API producers including a modern R&D Centre and full CRO facilities, which are all approved by every key regulator globally, including the US-FDA and UK MHRA.
Indoco continues to enhance its domestic presence via 10 marketing divisions and a well-developed and deep product pipeline including portfolios in gastro-intestinal, respiratory, anti-infectives, cardiovascular, pain management and many other therapeutic segments. Indoco's international collaborations with leading global generic companies fortify the reach of our trusted molecules into multiple therapeutic segments.
