Indoco Remedies clears USFDA inspection at Patalganga API facility with zero observations
Noor Mohmmed
19/Sep/2025

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Indoco Remedies’ Patalganga API manufacturing facility cleared USFDA inspection with zero form 483 observations, reflecting strong quality systems
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The inspection underscores Indoco’s commitment to regulatory compliance, operational excellence, and safe medicines for global markets
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Indoco’s 11 facilities, robust R&D, and strong brand portfolio support its global presence and continued growth in domestic and international markets
Indoco Remedies Limited, a fully integrated research-oriented pharmaceutical company, announced the successful completion of the United States Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredients (API) manufacturing facility in Patalganga, Navi Mumbai. The inspection concluded with zero form 483 observations, highlighting the company’s dedication to quality, regulatory compliance, and operational excellence.
The Managing Director of Indoco Remedies, Ms. Aditi Panandikar, stated that the successful inspection demonstrates the company’s strong quality culture embedded in every process and product. The company continues to strengthen its systems to ensure the delivery of safe and efficacious medicines across domestic and international markets.
Indoco Remedies has a turnover of US$ 180 million and employs over 6,000 professionals, including more than 400 skilled scientists and field staff. Its manufacturing infrastructure comprises 11 facilities, with 7 for Finished Dosage Forms (FDFs) and 4 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. These facilities have been approved by leading regulatory authorities, including USFDA and UK-MHRA, ensuring compliance with stringent global standards.
The company manufactures a wide range of pharmaceutical products, catering to multiple therapeutic segments such as Gastro-intestinal, Respiratory, Anti-Infectives, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, and Gynaecology. Its strong brand portfolio, including names such as Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Aloja, Glychek, Kidodent, Subitral, Rexidin, MCBM 69, Methycal, Dropizin, Noxa, Homide, Cal-Aid, Ninaf, CitalUti, and Otorex, contributes to over 106 million prescriptions annually from more than 2,40,000 doctors across India.
Indoco’s global collaborations with leading generic pharmaceutical companies strengthen its international footprint, enhancing its ability to deliver high-quality medicines worldwide. The USFDA inspection success reinforces the company’s commitment to excellence, safety, and compliance, positioning it for continued growth in both domestic and international markets.
For further information on Indoco Remedies Limited, visit www.indoco.com. The company remains fully committed to transparency, regulatory compliance, and the highest standards of pharmaceutical manufacturing.
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