Centaur Pharma’s API Ambernath facility receives EIR from USFDA


Centaur Pharmaceuticals’ state-of-the-art API Ambernath facility was audited by the USFDA and a 483 form was issued with one observation which was responded to, immediately.Centaur has now received a formal EIR (Establishment Inspection Report) from USFDA stating the facility is CGMP compliant and the audit outcome is categorized as VAI (Voluntary Action Indicated). This is the fifth successive GMP certification for the Centaur Ambernath API facility by the USFDA in a span of 11 years.

In addition to the USFDA accreditation, the Ambernath facility conforms to EUGMP/ANSM (France), TGA, PMDA (Japan), KFDA (Korea), ANVISA (Brazil), COFEPRIS (Mexico) and WHO-GMP standards.Centaur is India’s largest, and the world’s third-largest manufacturer of psychotropic API. Centaur manufactures over 50 API, of which 32 have been introduced for the first time in India.

“Centaur Pharma has been diligently complying with GMP regulations to work towards zero observations in USFDA inspections. We have faced over fifteen audits by the USFDA in the past decade, for our various facilities and successfully cleared the same,” said S.D. Sawant, Managing Director, Centaur Pharmaceuticals.
“This is a proud moment for Centaur, and a significant milestone for the Indian pharmaceutical industry,” he added.
Earlier in May 2019, Centaur Pharmaceuticals’ oral solid dosage facility in Pune had received no action indicated (NAI) compliance status, with zero 483 observations from the USFDA.

In addition to the USFDA accreditation, the Pune facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards.In September 2019 LifeSan, the clinical research division of Centaur Pharmaceuticals was audited by the US FDA and was concluded with zero 483 observations.
Centaur Pharmaceuticals is a 100 million dollars Indian pharmaceutical company with exports to 110 countries. Centaur has a presence across the pharmaceutical value chain with proficiency in API, formulations, clinical research, and contract manufacturing.Centaur is ranked 35th in India by prescriptions and markets Sinarest the leader in the anticold prescription market for over two decades.


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