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Centaur Pharmaceuticals, India’s largest manufacturer and exporter of psychotropic API. has received a formal Establishment Inspection Report (EIR) from US FDA stating the facility is cGMP compliant and the audit outcome is categorized as Voluntary Action Indicated (VAI).
This is the fifth successive GMP certification for the Centaur Ambernath API facility by the US FDA in a span of 11 years.
Centaur Pharmaceuticals API facility in Ambernath was issued a 483 form with one observation which was responded to immediately by the company.
In addition to the US FDA 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.
S D Sawant, managing director, Centaur Pharmaceuticals said, “Centaur Pharma has been diligently complying with GMP regulations to work towards zero observations in US FDA inspections. We have faced over fifteen audits by the US FDA in the past decade for our various facilities and successfully cleared the same.”
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 US FDA. In addition to the US FDA 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 US$ 100 million Indian pharmaceutical company with exports to 110 countries. Centaur has presence across the pharmaceutical value chain with proficiency in API, formulations, clinical research and contract manufacturing.
Centaur ranked 35th in India by prescriptions and markets Sinarest the leader in the anticold prescription market for over two decades.
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