Indoco’s Clinical Research Organisation receives zero 483s from US FDA
The company also recently successfully concluded an audit by US FDA at its sterile manufacturing facility in Goa (Plant II)
Indoco Remedies announced that its Clinical Research Organisation, AnaCipher, located at Hyderabad successfully cleared the United States Food and Drug Administration (US FDA) inspection with zero 483s. The inspection was held from 14th October to 18th October, 2019.
Commenting on this development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited said, “This achievement is for the fifth time in a row and confirms the capabilities of our team at the CRO for maintaining highest quality standards and excellence in servicing our clients”.
The CRO – AnaCipher conducts Bio-Equivalence and Bio-Availability (BA/BE) studies at its facility in Hyderabad and is spread over an area of 30,000 sq ft with 98 beds.
The company also recently successfully concluded an audit by US FDA at its sterile manufacturing facility in Goa (Plant II) from 7th October to 15th October, 2019.
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