The National Medical Products Administration (NMPA) issues product license for Abiraterone acetate 250 mg, Bioequivalance study conducted in India by Accutest Research Laboratories (I) Pvt. Ltd., one of the Top Indian CRO
BEIJING and MUMBAI, India, Sept. 6, 2021 /PRNewswire/ -- National Medical Products Administration (NMPA) China, announces the approval of Abiraterone acetate 250mg of Qilu Pharmaceuticals for marketing purpose.
Applicable Bioequivalance studies for marketing authorization were conducted at Accutest Research Laboratories (I) Pvt. Ltd., at its Indian facility.
Accutest is a Contract Research Organization (CRO) offering full range of services based in India. Originally the projects were done for USFDA in late 2017. In early 2018, subsequent to approval from USFDA, Qilu Pharmaceutical Co. Ltd., China, had applied for NMPA's approval and license was granted in Apr-2020.
An official from 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 the undisputed and 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 USFDA, EMA, ANVISA-Brazil, WHO, MHRA-UK, MCC-South Africa and other international regulatory bodies (based on projects).
Accutest is operating from 3 facilities (Ahmedabad, Vadodara and Navi Mumbai) that are approved from ANVISA-Brazil, NPRA-Malaysia, DCGI-India, MOH-Turkey, ISP-Chile, MOH-UAE, MOH-Thailand etc.
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 now. Accutest has dedicatedly executed many projects during critical COVID-19 period to meet the sponsor dossier timelines."
Accutest is a global independent and internationally accredited Contract Research Organisation ("CRO") founded in 1998. We are offering services to customers around the world with operations in India, across Asia, and in Brazil. Accutest is the market leader amongst independent CROs, with the highest quality standards and quick turnaround times. We have a strong regulatory track record and numerous accreditations/approvals from global regulatory agencies.
SOURCE Accutest Research Laboratories (I) Pvt. Ltd.
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