Indoco Remedies gets 7 USFDA observations for Goa facilities
Mumbai: Through a recent BSE filing, Indoco Remedies has informed that the Company has received seven observations in Form 483 from the United States Food and Drug Administration (USFDA) after the inspection at manufacturing facilities at Plant II (Sterile) and Plant III located at Goa (“Facility”).
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
USFDA inspected the Company’s manufacturing facilities from July 16, 2024 to July 26, 2024.
"We are addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe," the Company stated.
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The Company’s turnover is US$ 212 million. 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 2,35,000 doctors belonging to various specialties. Indoco has 8 domestic marketing divisions a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, 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, Dropizine, Noxa, Homide, Cal-Aid, etc.
