By: IPP Bureau
Last updated : September 06, 2021 3:46 pm
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The National Medical Products Administration (NMPA) China announces the approval of Abiraterone acetate 250mg of Qilu Pharmaceuticals for marketing purposes. The applicable bioequivalence studies for marketing authorization were conducted at Accutest Research Laboratories (I) at its Indian facility.
Accutest is a Contract Research Organization (CRO) offering a full range of services based in India. Originally the projects were done for US FDA in late 2017. In early 2018, after approval from US FDA, Qilu Pharmaceutical Co. China had applied for NMPA's approval and the license was granted in Apr-2020.
An official from the Clinical affairs department of Qilu Pharma said, "Thanks to Accutest Research Laboratories, we have successfully achieved our goal in the advance for the Abiraterone acetate projects. They have good experience on many projects and investigators also have too much patience towards subjects."
Accutest is an independent global partner for clinical research and drug development. Accutest offers services like BABE, Phase II-IV Clinical trials, and testing of Biologics/Biosimilar products. It has passed multiple regulatory inspections from US FDA, EMA, ANVISA-Brazil, WHO, MHRA-UK, MCC-South Africa, and other international regulatory bodies (based on projects).
The Managing Director and CEO, Dr Satish Sawant said, "We are extremely happy to assist our client Qilu in achieving their marketing approvals from USFDA and NMPA. We take pride in providing accuracy, data integrity, and cost-effectiveness. We have been providing high-quality research services to the pharma industry across the globe for more than two decades.’’
Accutest operates from 3 facilities (Ahmedabad, Vadodara, and Navi Mumbai) that are approved from ANVISA-Brazil, NPRA-Malaysia, DCGI-India, MOH-Turkey, ISP-Chile, MOH-UAE and MOH-Thailand.