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USFDA finds zero 483 observations and grants NAI to Centaur Pharmaceutical's finished dosage facility in Pune


based Centaur Pharmaceuticals' finished dosage facility in Pune was audited by the USFDA in May 2019 and the audit was concluded with NIL 483 observations.

The company received No Action Indicated (NAI) compliance status with zero 483 observations from the USFDA which signifies compliance and conformance to applicable cGMP regulations

"The NAI is a significant development not only for Centaur but also for the Indian pharmaceutical industry, considering the increasing global regulatory headwinds in the last few years", said S D Sawant, Managing Director, In addition to USFDA accreditation, the said facility also conforms to (UK), TGA (Australia), Canada, MCC (South Africa) and WHO-GMP standards.

If the investigating observes conditions which in his or her judgment are violations of the Food Drug and Cosmetic (FD & C) Act or related acts, then he or she may issue the concerned firm an Form 483.

On the other hand, an inspection results in an NAI inspection classification when the inspection either reveals no objectionable conditions or that the significance of the documented objections does not warrant further action. This classification signifies the compliance status of the concerned establishment at the time of inspection, based on the recorded observations.

"The conclusions of the inspection are reported as No Action Indicated (NAI) which is vindication of Centaur's efforts over the past 40 years in ensuring quality and maintaining international standards across the in API, formulations, clinical research and contract manufacturing," said Dr Jayashing Sawant, President- Technical,

Centaur is also India's largest and the world's third largest manufacturer of psychotropic with state of the art facility conforming to USFDA, EUGMP/ANSM (France), TGA, PMDA (Japan), KFDA (Korea), ANVISA (Brazil), COFEPRIS (Mexico) and WHO-GMP standards.

Centaur's (Active Pharmaceuticals Ingredients) formulations plant situated in Ambernath, is also a USFDA approved the plant. In addition, also has two world-class formulations facilities in which are WHO-GMP approved.

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First Published: Tue, June 11 2019. 08:30 IST