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

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.

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.”

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].

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.

Tags : #LifeSan # # #Clinical #Research # #US #FDA

Related Stories

Loading Please wait...


Trending Now

Exploring the Link Between Covid-19 Vaccination and Sudden Cardiac Arrests: ICMR StudyNovember 22, 2023
Powering the Future: China's Biodegradable Wireless System for Bioelectronic InnovationNovember 22, 2023
IMS BHU Pioneers Advanced Cardiac Care: Unveiling Cutting-Edge Technologies for Precise DiagnosisNovember 18, 2023
Inito's $6 Million Boost: Transforming Women's Health with AI-Backed Fertility MonitoringNovember 18, 2023
Madras High Court Advocates for Equality: PG Medical Students to Receive Incentive Marks for COVID-19 DutyNovember 18, 2023
Next-Gen Healthcare: CarePods and AI Redefine the Patient ExperienceNovember 17, 2023
Air Quality Crisis: Alarming Rise in Premature Births Linked to Air Quality in Begusarai, BiharNovember 17, 2023
Limerick Contest-2023: A Celebration of Wit and PoetryNovember 17, 2023
IIIT-Hyderabad among top 100 institutions for 5G Use Case LabNovember 17, 2023
Powerful, motivating and inspiring talks marked TEDx Hyderabad Women 2023 which was held with the theme "Two Steps ForwardNovember 17, 2023
Speaking the Diagnosis: How AI in Voice Analysis Is Revolutionizing Diabetes DetectionNovember 17, 2023
FDA Approves Zepbound: A New Medication for Weight Loss by Eli LillyNovember 17, 2023
CoverSelf Raises $8.2 Million in Seed Funding to Revolutionize Healthcare Claims with Innovative Fintech PlatformNovember 16, 2023
From Miracle to Medic: The Extraordinary Journey of India's First Paediatric Liver Transplant RecipientNovember 16, 2023
Combatting Chikungunya: Valneva's Chikungunya Vaccine Cleared by USFDA, Eyes India LaunchNovember 16, 2023
Global Corporate Summit 2023 with the theme Unlocking Opportunities in a Dynamic World heldNovember 16, 2023
2nd IHub-Data Mobility Summit heldNovember 16, 2023
Revolutionary AI-powered technology detects multiple abdominal pathologies simultaneouslyNovember 16, 2023
1 Out of 3 Stroke Patients Suffer Long-Term Health Complications, Says NeurologistNovember 16, 2023
Amrita Hospital, Kochi, Launches App for People with Swallowing DifficultiesNovember 15, 2023