USFDA successfully completes inspection at Indoco API Kilo Lab facility, IAS division with no observations
Mumbai: Indoco Remedies Limited has announced that the United States Food and Drug Administration (USFDA) successfully completed inspection of its API Kilo Lab manufacturing facility at Rabale, Navi Mumbai and Indoco Analytical Solutions (IAS) division.
The inspection concluded with zero Form 483 observations, reflecting the company's commitment to maintaining the highest standards of quality and compliance.
“We are extremely happy with the outcome of this inspection. This achievement reflects our relentless focus on quality and compliance in everything we do. We remain committed to ensuring the safety and efficacy of our products while maintaining the trust of our customers and stakeholders”, said Aditi Panandikar, Managing Director, Indoco Remedies Limited.
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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.
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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 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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