Indoco Remedies Ltd. announced today, the receipt of Establishment Inspection Report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the inspection carried out by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from 5th August to 9th August, 2019. The inspection was successfully conducted without any observations and stands closed now.
“We strictly adhere to regulatory guidelines and maintain highest standards in delivering quality services to our clients. This has resulted in zero 483s in the last five successive USFDA inspections.” stated Ms. Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.
The CRO – AnaCipher conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility spread over an area of 30,000 sq. ft. with 98 beds. The CRO also has expertise in Bioanalytical work for new chemical entities (Phase I-III studies).
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.