Indoco Annonunces EIR Received by CRO – AnaCipher from USFDA
Posted on November 26, 2019
Indoco Remedies Ltd. announced, the receipt of 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 5th August to 9th August, 2019. The inspection was successfully conducted without any observations and stands closed now.
“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.” stated Ms. Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.
The CRO – AnaCipher conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility spread over an area of 30,000 sq. ft. with 98 beds. The CRO also has expertise in Bioanalytical work
for new chemical entities (Phase I-III studies).
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