Indoco's Clinical Research Organisation - AnaCipher completes US FDA inspection

Indoco Remedies Limited (Indoco) announced today that its Clinical Research Organisation, AnaCipher, located at Hyderabad, has completed its 5-day comprehensive USFDA inspection. The on-site inspection was conducted from 3rd March, 2025 to 7th March, 2025, by investigators from Bioresearch Monitoring Program (BIMO) and Office of Study Integrity & Surveillance (OSIS) of US FDA.

The inspection covered both clinical and bioanalytical phases of three Bioavailability and Bioequivalence (BA/BE) studies submitted by clients, to the US Food and Drug Administration (FDA). The facility received one Form 483 at the end of the inspection, which will be responded within timeframe.

"This is an exciting step in our journey of excellence and a validation of our adherence to applicable regulations and maintaining the highest standards in delivering quality services to our clients." stated Ms. Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.

Shares of Indoco Remedies Limited was last trading in BSE at Rs. 231.65 as compared to the previous close of Rs. 234.45. The total number of shares traded during the day was 3766 in over 183 trades.

The stock hit an intraday high of Rs. 237.80 and intraday low of 227.35. The net turnover during the day was Rs. 869256.00.

Source : Equity Bulls

Keywords

IndocoRemedies INE873D01024 Pharmaceuticals CRO AnaCipher USFDA Inspection Form483 OneObservation