Compliance Management

WHO Removes India's Anuh APIs from Prequalification List

Apr 27, 2016

FDANews

The World Health Organization (WHO) has announced that it is removing two of Anuh Pharma’s products — pyrazinamide and sulfadoxine — from its list of prequalified APIs.

The decision came after a February inspection by French health officials of the API maker’s Boisar facility that turned up 24 deficiencies, according to FDANews. Subsequently, France’s health authority called for the withdrawal of Anuh’s GMP certificate.

WHO said the APIs will remain off its list until the facility’s GMP compliance status has been reinstated.