Indoco Remedies CRO AnaCipher gets one Form 483 from USFDA
Mumbai: Indoco Remedies Limited announced that its Clinical Research Organisation, AnaCipher, located at Hyderabad has received one Form 483 from the U.S. Food and Drugs Administration (USFDA) at the end of the 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.
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