Indoco Remedies gets 4 USFDA observations for Goa facility
Mumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has concluded the pre-approval inspection with four observations at the Company’s Solid Oral Formulation facility (Plant I) located at Goa (“Facility”). The inspection was conducted for two drug product applications (ANDAs) filed from this facility.The inspection was held from October 12,...
Mumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has concluded the pre-approval inspection with four observations at the Company’s Solid Oral Formulation facility (Plant I) located at Goa (“Facility”). The inspection was conducted for two drug product applications (ANDAs) filed from this facility.
The inspection was held from October 12, 2023 to October 18, 2023.
"The USFDA has issued ‘four observations’ in Form 483 at the end of the preapproval inspection. The Company is committed to address the observations comprehensively and within the stipulated time," Indoco stated in a BSE filing.
Medical Dialogues team had earlier reported that the Company had received EU GMP certification from the Competent Health Authority of Germany for its manufacturing site situated at L-32/33/34 Verna Industrial Estate, Goa. The EU GMP certification issued by the German Health Authority (LAGeSo) confirms that the site complies with the Good Manufacturing Practice requirements as referred to in the EC Directive.
Read also: Indoco Remedies gets EU GMP certification from German Health Authority for Goa facility (Plant III)
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 brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gyneacology etc. Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, 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.
Read also: Indoco Remedies Baddi facility gets GMP certification from EU Health Authority
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