Indoco Remedies Ltd. announced today, that its Clinical Research Organisation, AnaCipher, located at Hyderabad successfully cleared the United States Food and Drug Administration (USFDA) inspection with zero 483s. The inspection was held from 14th October to 18th October, 2019.
Commenting on this development, Ms. 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”.
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.
About Indoco Remedies Limited:
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. Indoco, a USD 140 million Company, employs over 6000 people including more than 300 skilled scientists.
The Company 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. It generates more than 70 million prescriptions annually from around 3,10,000 doctors belonging to various specialties. Indoco 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) – USA and ASPEN-South Africa.