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12
2023
-
09
Good news! The solid production line of the company's Tongchuan base has passed the drug production license and GMP compliance inspection
Author：
Quality Management Center contribution
Good News! The solid workshop of our Tongchuan factory obtained "Drug Manufacturing License" on August 18th, and "Drug GMP Compliance Inspection Result Notification Letter" on August 24th, 2023.
From July 10 to July 14, 2023, the expert group of Shaanxi Provincial Food and Drug Administration conducted a GMP compliance inspection of drug production license and combined drug GMP on the solid workshop hard capsules, tablets, granules and pills production lines of our company's Tongchuan base. After the unanimous review of the expert group, the solid workshop of our company's Tongchuan base meets the conditions for drug production and has large-scale production capacity!
The certification of the solid workshop marks that Tongchuan base has the production scope and large-scale production capacity of "granules, tablets, capsules, pellets, compounds, syrups, and traditional Chinese medicine extraction", and the certification will greatly improve the production scope and large-scale production capacity of Tongchuan base, and lay the foundation for meeting the company's growing sales demand and the realization of the company's next strategic goals.
In 2018, our company invested in the establishment of Tongchuan base project, which covers an area of 91 acres, with a construction area of 47,000 square meters and a total investment of 350 million yuan. It is expected that 15 modern production lines will be planned to meet the production capacity of Chinese and Western medicines and formulated granules of more than 200 specifications.
In the past five years, the company has successively built 10 buildings such as traditional Chinese medicine extraction, comprehensive preparation, R&D synthesis, fire protection, and environmental protection, and passed the GMP compliance inspection of extraction workshop and liquid workshop in 2021 and 2022; It has now entered the normal production operation state. Since the beginning of this year, with the careful preparation and cooperation of all departments of the company, it finally successfully passed the review of drug production license combined with drug GMP compliance inspection by the expert group of the Provincial Food and Drug Administration, and the company obtained the "drug production license" on August 18, 2023, and the "letter of notification of drug GMP compliance inspection results" on August 24.
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