Indoco Remedies' CRO clears USFDA inspection with no observation

New Delhi: Indoco Remedies on Monday said its Hyderabad-based clinical research organisation AnaCipher has successfully undergone inspection by the US health regulator with no observations.

The US Food and Drug Administration (USFDA) inspected AnaCipher from September 12-16, 2022, Indoco Remedies said in a regulatory filing.

"The clinical phase of inspection covered three BA/BE (bioavailability/bioequivalence) studies submitted by clients to the USFDA and was successfully concluded with zero (Form) 483s," it added.

As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Indoco Remedies' Managing Director Aditi Kare Panandikar said this is the seventh successive USFDA inspection with zero Form 483s for AnaCipher clinical research organisation (CRO).

AnaCipher CRO facility is spread over 40,000 square feet area with 98 beds. It conducts BA/BE studies. The CRO has successfully completed more than 500 studies in multiple therapeutic areas such as, cardiovascular, diabetes, oncology, antiretrovirals and antacids, the company said.

The CRO also has expertise in bioanalytical work for new chemical entities (Phase I-III studies) for pharmaceutical companies globally, it added.