Indoco's CRO, AnaCipher receives EIR from US FDA

Our Bureau, Mumbai

Tuesday, November 26, 2019, 15:45 Hrs [IST]

Indoco Remedies Ltd has received Establishment Inspection Report (EIR) from United States Food and Drug Administration for its clinical research organisation (CRO), AnaCipher, located at Hyderabad.

The company added that the inspection carried out by the US FDA (division of New Drug Bioequivalence Evaluation) from 5th to 9th August, 2019

"The inspection was successfully conducted without any observations and stands closed now," the company said in a filing.

"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 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).