Indoco Remedies Receives USFDA EIR for Patalganga API Facility

Indoco Remedies Ltd announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredients (API) manufacturing facility located at Patalganga. The inspection of the facility was conducted from September 15 to September 19, 2025. This development follows the company’s previous communication regarding the successful completion of the USFDA inspection.

The receipt of the EIR indicates that the Patalganga facility complies with the USFDA’s regulatory requirements. This is a significant step for Indoco Remedies in maintaining its operational standards and regulatory compliance for its API manufacturing processes.

Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The company operates 11 manufacturing facilities, including 7 for Finished Dosage Forms (FDFs) and 4 for APIs. These facilities are supported by a state-of-the-art Research and Development (R&D) Centre and a Contract Research Organization (CRO) facility. The company’s facilities have received approvals from various regulatory authorities, including the USFDA and UK-MHRA.

Indoco Remedies develops and manufactures a wide range of pharmaceutical products for both Indian and international markets. The company generates over 106 million prescriptions annually from more than 240,000 doctors across various specialties. Indoco has 10 domestic marketing divisions and a strong brand portfolio in therapeutic segments such as Gastro-intestinal, Respiratory, Anti-Infectives, and others.

For more information on Indoco Remedies and its operations, visit the company’s official website.