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Shandong Hubble Kisen successfully obtained the Drug Production License

2023-04-13 09:50:36

On August 19, 2020, Shandong Hubble Kisen, a subsidiary of Taienkang, successfully passed the on-site inspection of the Shandong Provincial Drug Administration’s "Research and Development Institution as a Drug Marketing Authorization Holder Applying for the "Drug Production License"" and became a Shandong Provincial The second research and development institution to obtain the "Pharmaceutical Production License". At present, the approved drug Aitingjiu (Dapoxetine Hydrochloride Tablets) has been entrusted to Yantai Luyin Pharmaceutical Co., Ltd. for commercial production.

Through the establishment of a sound drug quality assurance, risk control, drug traceability and pharmacovigilance four systems, perfect MAH full life cycle management system, supervision of entrusted drug production enterprises continue to have quality assurance and control capabilities, and the entrusted drug production enterprise quality management system effective connection.

In the process of MAH system from pilot to implementation, Shandong Hubble Kisen has the courage to explore and be the first. The approval of Aitingjiu (Dapoxetine Hydrochloride Tablets) is not only the first imitation in China, but Shandong Hubble Kisen has also become the first drug research and development company in Shandong Province to obtain a production approval in the form of MAH. The successful application of the "Drug Production License" also makes Shandong Hubble Kisen become the first batch of national research and development institutions to obtain the "Drug production license", in the industry to explore and open a new mode of operation, set a good example for the industry.

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