FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations
Drug Approval

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations

  • By IPP Bureau | September 19, 2025

Indoco Remedies Limited announced today that the United States Food and Drug Administration (USFDA) successfully completed inspection of its Active Pharmaceutical Ingredients (API) manufacturing facility at Patalganga, Navi Mumbai.

The inspection concluded with zero form 483 observations, reflecting the company's commitment to the highest standards of quality, regulatory compliance and operational excellence.

“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,” said Aditi Panandikar, Managing Director, Indoco Remedies Limited.  

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