Indoco Remedies AnaCipher CRO clears USFDA inspection with Zero observation
Mumbai: Indoco Remedies Ltd. announced today that its Clinical Research Organisation, AnaCipher, located in Hyderabad, was inspected by the United States Food and Drug Administration from September 12 to September 16, 2022.
The clinical phase of inspection covered three BA/BE studies submitted by clients to the USFDA and was successfully concluded with zero 483s.
"This is the seventh successive USFDA inspection with ZERO 483s for AnaCipher CRO. We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients.", said Ms. Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.
AnaCipher CRO, based in Hyderabad, is a USFDA inspected clinical research facility and is spread over 40,000 sq. ft area. The CRO has successfully completed more than 500 studies in multiple therapeutic areas such as, cardiovascular, diabetes, oncology, anti-retrovirals and antacids.
Read also: Indoco Remedies successfully concludes USFDA inspection of CRO Anacipher in Hyderabad
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. The Company has 9 manufacturing facilities, 6 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 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.
It generates more than 70 million prescriptions annually from over 3,00,000 doctors belonging to various specialties. lndoco has 9 domestic marketing divisions with a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gyneacology etc. Top lndoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM 69, Methycal, Homide, Cal-Aid, etc. On the international front, lndoco has tie-ups with large generic companies across the globe.
