USFDA issues EIR for Indoco Remedies Goa facility
Mumbai: Indoco Remedies Ltd. announced today the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for their facility for solid dosages (Plant I) located in Verna, Goa.
The recent inspection held from January 16, 2023, to January 20, 2023, was a surveillance inspection.
"The receipt of the EIR with VAI status also signifies the imminent closeout of the Warning Letter issued by the USFDA in July 2019 for the manufacturing site, situated at L-14, Verna Industrial Road, Goa (Plant I)," the company stated.
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Commenting on this positive development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd., said, "We are happy to receive the EIR in three and a half months’ time from the date of inspection. It is very encouraging that the site has been endorsed with VAI status, from (Official Action Indicated) OAI status, by the US Regulators. We are committed to maintaining strict adherence to the highest quality standards and to ensuring delivery of safe and effective generic medicines to our patients in the U.S. and around the world."
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. 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 in Hyderabad.
The facilities have been approved by various 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 83 million prescriptions annually from over 3,00,000 doctors belonging to various specialties. Indoco has 8 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.
