Indoco Remedies Ltd. announced on Monday that it's Clinical Research Organisation, Anacipher, located at Hyderabad had undergone a walk-in surveillance inspection by the United States Food and Drug Administration (a division of New Drug Bioequivalence Evaluation) from August 5 to August 9, 2019. The inspection successfully concluded without any observations and no form 483 is issued.

“This is the fourth successive USFDA inspection with ZERO 483 for our CRO – AnaCipher. We are committed to strict adherence to regulatory guidance and maintaining highest standards in delivering quality services to our clients,” Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited said.

The CRO - AnaCipher conducts Bio-Equivalence and Bio-Availability (BA/BE) studies at its facility spread over an area of 30,000 sq. ft. with 98 beds. CRO also has expertise in Bio-Analytical work for new chemical entities (Phase I-III studies).