Indoco Remedies CRO AnaCipher gets Establishment Inspection Report from USFDA

New Delhi: Drug firm Indoco Remedies Ltd. recently announced 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 (a 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.

Commenting on the same, Aditi Kare Panandikar, Managing Director, Indoco Remedies stated, “We strictly adhere to regulatory guidelines and maintain the highest standards in delivering quality services to our clients. This has resulted in zero 483s in the last five successive USFDA inspections.”

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).

Also Read: Indoco Remedies gets USFDA ANDA nod for Glycopyrrolate Injection

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.

The company has 9 domestic marketing divisions with a 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.

Also Read: Indoco Remedies successfully clears USFDA inspection of CRO facility AnaCipher