News
Warmest congratulations! | Wanbangde Pharmaceutical Group's Biphenyl Dimethyl Ester API has successfully passed the on-site inspection by South Korea's MFDS!
Date:
13 Apr,2024
Wanbande Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Wanbande Pharmaceutical") underwent a routine on-site inspection from March 5 to 7, 2024, conducted by South Korea's Ministry of Food and Drug Safety (MFDS), focusing on the Korean registration of its Biphenyl Diester active pharmaceutical ingredient. The inspection covered comprehensive systems including quality, manufacturing, equipment and facilities, laboratory controls, as well as material and packaging labeling practices.
Recently, Wanbangde Pharmaceutical received a notification letter from South Korea’s MFDS regarding the "On-site Inspection Results for Overseas Pharmaceutical Manufacturers." This time, the company successfully passed the MFDS on-site inspection with zero deficiencies, confirming that Wanbangde Pharmaceutical’s active pharmaceutical ingredient (API) GMP operations comply with South Korea’s stringent pharmaceutical production and quality management standards. This milestone not only validates the effective implementation of the company’s robust quality management system but also underscores its unwavering commitment to rigorously adhering to GMP guidelines throughout every stage of production. As a result, the Biphenyl Diester product will continue to be marketed in the Korean market, fostering stronger collaboration with South Korean customers and providing a fresh impetus for the company to further expand into international markets—ultimately enhancing its overall competitiveness.
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