Indoco Remedies successfully concludes USFDA inspection of CRO Anacipher in Hyderabad
This inspection was conducted by the Division of New Drug Study Integrity, Office of Study Integrity and Surveillance of USFDA.
New Delhi: Indoco Remedies has recently announced the successful conclusion of the US Food and Drug Administration (USFDA) inspection at Indoco's Clinical Research Organization - AnaCipher.
The inspection was conducted between 11th - 15th July, 2022.
"During the remote record review, the agency did not identify any objectionable conditions and thus, did not have any observations," the company stated in its recent BSE filing.
This inspection was conducted by the Division of New Drug Study Integrity, Office of Study Integrity and Surveillance of USFDA. The scope of the inspection included Bioanalytical phase of multiple studies, of which one was "First to File".
Read also: Indoco Remedies bags USFDA nod for Lacosamide Injection
Indoco Remedies Ltd. had earlier announced the receipt of GCP & GLP accreditation from the UK-MHRA (Medicines and Healthcare Products Regulatory Agency) for its Clinical Research Organisation - AnaCipher, located at Hyderabad.
Read also: Indoco Remedies clinical research organisation AnaCipher gets UK MHRA accreditation
AnaCipher Clinical Research Organization, a division of Indoco Remedies Ltd. is a Contract Research Organization specialized in bioequivalence and analytical studies. The state-of-the-art facility is spread over an area of 30,000 sq. ft. at Hyderabad, India, with capabilities to conduct bioavailability and bioequivalence studies, bioanalytical method development and validation, sample processing and analysis, statistical analysis and reporting.
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.
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.
Read also: Indoco Remedies clinical research organisation AnaCipher gets UK MHRA accreditation
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