Centaur Pharmaceuticals clears USFDA audit of Pune plant
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
June 11, 2019 / 06:30 PM IST
Centaur Pharmaceuticals on June 11 said its Pune finished dosage facility had completed USFDA audit with zero Form 483 observations.
The company received a No Action Indicated (NAI) compliance status with zero 483 observations from the USFDA which signifies compliance and conformance to applicable cGMP regulations
The successful audit will allow Centaur to expand in US market.
“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 pharmaceutical value chain in API, formulations, clinical research and contract manufacturing” said Jayashing Sawant, President- Technical, Centaur Pharmaceuticals.
Centaur is also India’s largest and the world’s third largest manufacturer of psychotropic active pharmaceutical ingredients (APIs) .
Centaur’s API (Active Pharmaceuticals Ingredients) formulations plant situated in Ambernath, Maharashtra is also an US FDA approved plant. In addition, Centaur Pharmaceuticals also has two formulations facilities in Goa which are WHO-GMP approved.
Centaur is a $100 million company by sales with exports to 110 countries.