NMPA Grants Marketing Authorization for Qilu Pharmaceutical's Abiraterone Acetate 250mg

Beijing and Mumbai, India, Sept. 6, 2021 /PRNewswire/ --National Medical Products Administration(NMPA) announced approvalQilu Pharmaceutical250 mg abiraterone acetate has been launched.

Applicable bioequivalence studies for marketing authorization conducted byAccutestwas conducted at its Indian facilities by Research Laboratories (I) Pvt. Ltd.

Accutest is a full-service contract research organization (CRO) headquartered in India. These studies were initially conducted in late 2017 to obtain U.S. FDA approval. Following U.S. FDA approval in early 2018, Qilu Pharmaceutical Co., Ltd. received approval and authorization from China's National Medical Products Administration (NMPA) in April 2020.

A senior staff member of the Clinical Affairs Department at Qilu Pharmaceutical stated: “With the availability ofAccutest Research Laboratories, IThey have already successfully achieved the objectives of the abiraterone acetate project ahead of schedule. They have extensive experience in numerous projects, and the investigators demonstrate great patience toward the subjects.Heart.”

Accintest is an undisputed and independent global partner for clinical research and drug development. Accintest provides services including BABE (bioavailability and bioequivalence) studies, Phase II–IV clinical trials, and biologics/biosimilar product testing. It has successfully passed inspections by the US FDA, EMA, Brazil's ANVISA, WHO, UK MHRA, South Africa's MCC, and other international regulatory authorities (having completed multiple project-based regulatory inspections).

Accutest operates three facilities (Ahmedabad, Vadodara, and Navi Mumbai), which are approved by regulatory authorities including Brazil's ANVISA, Malaysia's NPRA, India's DCGI, the Turkish Ministry of Health, Chile's ISP, the UAE Ministry of Health, and the Thai Ministry of Public Health.

Dr. Satish Sawant, Managing Director and Chief Executive Officer, stated: “We are very pleased to assist our client, Qilu Pharmaceutical, in obtaining marketing approvals from the U.S. FDA and the China NMPA. We take pride in delivering accuracy, data integrity, and cost-effectiveness.”

“For over 20 years, we have been providing high-quality research services to the global pharmaceutical industry. During the critical COVID-19 pandemic, Accintest specifically executed numerous projects to meet sponsors' document preparation deadlines.”