Indoco Remedies' Hyderabad unit gets establishment inspection report from USFDA; Shares gain

Updated : November 26, 2019 10:18 AM IST

Shares of Indoco Remedies Ltd. rallied over 6 percent after it announced that its Clinical Research Organisation, AnaCipher, located at Hyderabad received Establishment Inspection Report (EIR) for the inspection carried out by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation).

The inspection was carried from August 5 to 9 and was successfully conducted without any observations and stands closed now, the company said in a regulatory filing.

At 10:15 am, shares of Indoco Remedies traded 3.53 percent higher at Rs 160 on the Bombay Stock Exchange.

“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,” said Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd.

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), the company added.