Drug firm Indoco Remedies on Tuesday said it has received establishment inspection report from the US health regulator for its clinical research organisation AnaCipher in Hyderabad.
The inspection was successfully conducted without any observations and stands closed now, the drug firm said in a BSE filing.
Indoco Remedies got "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 August 5 to August 9, 2019," the filing said.
AnaCipher conducts bio-equivalence and bio-availability studies at its facility in Hyderabad.
"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," Indoco Remedies Managing Director Aditi Kare Panandikar said.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
It notifies the company's management of objectionable conditions.
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