Indoco Remedies’ Clinical Research Organisation, AnaCipher, located at Hyderabad, has completed its 5-day comprehensive U.S. Food and Drug Administration (USFDA) inspection. The on-site inspection was conducted from March 3, 2025 to March 7, 2025, by investigators from Bioresearch Monitoring Program (BIMO) and Office of Study Integrity & Surveillance (OSIS) of USFDA.
The inspection covered both clinical and bioanalytical phases of three Bioavailability and Bioequivalence (BA/BE) studies submitted by clients, to the USFDA. The facility received 1 Form 483 at the end of the inspection, which will be responded within timeframe.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.