Indoco Remedies receives warning letter from USFDA for Goa facility
Mumbai: Indoco Remedies has received a warning letter from the US Food and Drug Administration (USFDA) for the company's Plant II & Plant III facility located at L 32, 33 - 34 Verna Industrial Estate Area, Verna, Goa, India (“Facility”).
The facility had previously been designated with an Official Action Indicated (OAI) status by the USFDA on October 11, 2024. This classification followed an inspection conducted at the site between July 16, 2024, and July 26, 2024.
Indoco is a fully integrated, research-oriented pharmaceutical company with presence in 55 countries. The Company’s turnover is US$ 200 million. The Company has 9 manufacturing facilities, 6 for FDFs and 3 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 107 million prescriptions annually from over 2,30,000 doctors belonging to various specialties. Indoco has 9 domestic marketing divisions with a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynecology, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, SensodentKF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM 69, Methycal, Homide, Cal-Aid, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.
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