Indoco Remedies successfully clears USFDA inspection of CRO facility AnaCipher

Commenting on this development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited said, “This achievement is for the fifth time in a row and confirms the capabilities of our team at the CRO for maintaining highest quality standards and excellence in servicing our clients”.

Mumbai: Indoco Remedies Ltd. recently cleared the US health regulator's inspection of its Clinical Research Organisation, AnaCipher, located at Hyderabad without any observations.

The CRO - AnaCipher conducts Bio-Equivalence and Bio Availability (BA/BE) studies at its facility in Hyderabad and is spread over an area of 30,000 sq. ft. with 98 beds.

The inspection for the facility was held from October 14th to October 18th 2019.

"Indoco Remedies successfully cleared the United States Food and Drug Administration (USFDA) inspection with zero 483s.," Indoco says in a filing.

Commenting on this development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited said, “This achievement is for the fifth time in a row and confirms the capabilities of our team at the CRO for maintaining highest quality standards and excellence in servicing our clients”.

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Headquartered in Mumbai, Indoco has 9 manufacturing facilities, 6 of which are 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 USFDA, UK-MHRA, TGA-Australia, PMDA-Japan, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets.

The company has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Respiratory, Anti-Infective, Dental Care, Pain Management, Gastro-intestinal, Ophthalmic, Cardiovascular, Anti-Diabetics, Anti-Obesity, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent-KF, Karvol Plus, Glychek, Kidodent, Carmicide, Bactogard, etc. On the international front, Indoco has tie-ups with large generic companies like Watson (Actavis) – the USA and ASPEN-South Africa.

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