USFDA19 Sept 2025, 02:37 pm
USFDA Completes Inspection at Indoco's API Manufacturing Facility with Zero Observations
AI Summary
Indoco Remedies Ltd. announced that the USFDA successfully completed inspection of its API manufacturing facility at Patalganga, Navi Mumbai with zero form 483 observations. This reflects the company's commitment to the highest standards of quality, regulatory compliance, and operational excellence. Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence and a turnover of USD 180 million. It has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, and generates over 106 million prescriptions annually.
Key Highlights
- USFDA successfully completes inspection at Indoco’s API manufacturing facility at Patalganga with zero observations
- Indoco Remedies Limited demonstrates commitment to highest standards of quality, regulatory compliance, and operational excellence
- Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence and a turnover of USD 180 million
- Indoco has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, and generates over 106 million prescriptions annually
- Indoco facilities have been approved by most of the Regulatory Authorities including USFDA and UK-MHRA