Indoco's CRO, AnaCipher clears US FDA inspection with zero 483

Our Bureau, Mumbai

Monday, August 12, 2019, 17:30 Hrs [IST]

Indoco Remedies Ltd. announced that its clinical research organisation, AnaCipher, located at Hyderabad had undergone a walk-in surveillance inspection by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from 5th August to 9th August, 2019. The inspection successfully concluded without any observations and no form 483 is issued.

This is the fourth successive US FDA inspection with ZERO 483 for our CRO AnaCipher. We are committed to strict adherence to regulatory guidance and maintaining highest standards in delivering quality services to our clients., stated Aditi Kare Panandikar, managing director, Indoco Remedies Limited.

The CRO, AnaCipher conducts bio-equivalence and bio-availability (BA/BE) studies at its facility spread over an area of 30,000 sq. ft. with 98 beds. CRO also has expertise in bio-analytical work for new chemical entities (phase I-III studies).

Indoco Remedies Ltd is a research-oriented pharma Company with presence in 55 countries. Indoco, a US$ 140 million company, employs over 6,000 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.