Indoco Remedies Receives USFDA Clearance for Patalganga API FacilityIndoco Remedies Receives USFDA Clearance for Patalganga API Facility

Indoco Remedies Limited has successfully received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredients (API) manufacturing site in Patalganga, Maharashtra.

The issuance of the EIR signifies the formal closure of the inspection conducted between September 15 and September 19, 2025. The successful outcome confirms that the facility operates in compliance with Current Good Manufacturing Practices (cGMP), allowing Indoco to continue supplying high-quality raw materials for the U.S. market.

Commitment to Global Quality Standards

With this regulatory milestone, Indoco reinforces its position as a reliable global supplier of pharmaceutical components. The Patalganga site is one of the company’s four specialized API units designed to feed its international formulation business and third-party requirements.

“We are pleased to have received the EIR from the USFDA for our API manufacturing facility located at Patalganga. This further reinforces our commitment to upholding the highest standards of quality and compliance, delivering trusted healthcare solutions to patients worldwide.” — Ms. Aditi Panandikar, Managing Director, Indoco Remedies Ltd.

Manufacturing and Research Prowess

Indoco Remedies maintains a robust infrastructure to support its growing international footprint:

11 Manufacturing Facilities: Comprising 7 Finished Dietary Formulations (FDF) units and 4 API units.
Global Approvals: Facilities are cleared by major regulatory bodies, including the USFDA and UK-MHRA.
Massive Reach: The company generates over 106 million prescriptions annually, supported by a network of over 240,000 doctors globally.

Looking Ahead

This clearance is expected to pave the way for new product filings and ensure a steady supply chain for Indoco’s existing portfolio in the United States. It underscores the company’s “state-of-the-art” approach to R&D and manufacturing excellence.