Indoco Remedies gets USFDA EIR for oral dosage facility at Goa plant I
Mumbai: Indoco Remedies Limited has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for the Pre-Approval Inspection (PAI) conducted for the oral dosage form at the manufacturing facility located at Goa Plant-I, L-14 Verna Industrial Area Verna, Goa, 403722, India, in October 2023.
The Company had addressed the observations comprehensively and within the stipulated time. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection. The PAI was conducted for two drug product applications (ANDAs) filed from this facility, for which approvals are expected soon.
Commenting on this development, Ms. Aditi Panandikar, Managing Director, Indoco Remedies said, “We stay committed to enabling affordable access to our high-quality products for patients in the US and around the world. This is a testament to our commitment to global standards of Quality and Compliance.”
Indoco is a fully integrated, research-oriented pharmaceutical 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. 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 109 million prescriptions annually from over 3,00,000 doctors belonging to various specialties. Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gyneacology 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, Dropizine, Noxa, Homide, Cal-Aid, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.
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