Indoco Remedies rose 3.53% to Rs 160 after the US drug regulator issued Establishment Inspection Report (EIR) to the company’s clinical research organisation in Hyderabad.
Indoco Remedies 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 (division of New Drug Bioequivalence Evaluation) from 5th to 9th August 2019. The inspection was successfully conducted without any observations and stands closed now.
“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.
The CRO -AnaCipher conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility spread over an area of 30,000 square feet with 98 beds. The CRO also has expertise in Bioanalytical work for new chemical entities (Phase I-III studies). The announcement was made during market hours today, 26 November 2019.