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Indoco Remedies gets USFDA EIR for Patalganga facility

Mumbai: Indoco Remedies Limited has announced that it has received 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.

This follows a successful Inspection of the said facility from 15th September, 2025 to 19th September, 2025.

Aditi Panandikar, Managing Director, Indoco said, “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.”
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The Company’s turnover is US$ 180 million with a human capital of over 6000 employees
The Company has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by most of the Regulatory Authorities including USFDA and UK-MHRA. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 106 million prescriptions annually from over 2,40,000 doctors belonging to various specialties. Indoco has 10 domestic marketing divisions, a strong brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infectives, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynaecology, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Aloja, Glychek, Kidodent, Subitral, Rexidin, MCBM 69, Methycal, Dropizin, Noxa, Homide, Cal-Aid, Ninaf, Cital- Uti, Otorex, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.

Read also: USFDA successfully completes inspection at Indoco Remedies Mumbai API facility

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