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Centaur Pharma’s Clinical Research Division, LifeSan Clinical Research Receives Zero 483 Observations From Back-to-Back US FDA Inspections

by businesswireindia.com

Business Wire India
LifeSan Clinical Research, the clinical research division of Centaur Pharmaceuticals was audited by the US FDA and was concluded with zero 483 observations which signifies compliance and conformance to applicable GCP regulations. LifeSan has successfully faced 6 inspections from US FDA; 2 inspections from MHRA/ EMA and 1 inspection from MCC, South Africa, in its twelve years of existence.
It undertakes bioavailability/ bioequivalence studies, which are mandatory for generic drug approval process and phase II/III clinical trials. Since inception, LifeSan has submitted many studies to regulatory agencies of US FDA, EMA, MCC South Africa and TGA, Australia as well as CDSCO, the Indian Drug Regulatory Authority, including successful conduct of phase II and III clinical trial of a new chemical entity [NCE].
Mr. S.D Sawant, Managing Director, Centaur Pharmaceuticals said, “The zero 483 observations to our clinical research division, LifeSan Clinical Research is yet another feather in our cap. We are happy with this significant development not only for Centaur but also for the Indian pharmaceutical industry. In addition to US FDA accreditation, the said facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards.”
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 US FDA accreditation, the Pune facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards.
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 is India’s largest and the world’s third largest manufacturer of psychotropic API with state of the art facility conforming to US FDA, EUGMP/ANSM (France), TGA, PMDA (Japan), KFDA (Korea), ANVISA (Brazil), COFEPRIS (Mexico) and WHO-GMP standards. On the domestic front, Centaur ranks among India’s top 35 firms by prescriptions. Centaur’s flagship brand Sinarest is a leader in the anticold market since 1996 and has won the AWACS brand of the year award for marketing excellence consecutively for the past 5 years. Centaur ranks among India’s top 5 companies in ophthalmologicals, with the highest growth trajectory.
Source: Businesswire