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Congratulations! Baihui Pharmaceutical's Aluminum Magnesium Carbonate Chewable Tablets Have Passed Consistency Evaluation
Release date:
2021-02-25
On February 23, 2021, the latest "Information on Drug Approval Documents Pending Collection," released by the National Medical Products Administration, revealed that the aluminum magnesium carbonate chewable tablets from Guangxi Nanning Baihui Pharmaceutical Group Co., Ltd. have successfully passed the bioequivalence evaluation for generic drugs, with acceptance number: CYHB2050212 Guo!
The consistency evaluation project for Aluminum Magnesium Carbonate Chewable Tablets was led by Baihui Pharmaceutical's Technology Center, with support from the Production Center, Quality Center, and Procurement Department. The project benchmarked against the internationally renowned pharmaceutical company Bayer of Germany. After more than two years of relentless effort, the team overcame numerous challenges—including issues related to raw materials, equipment, and technology—and successfully completed process validation as well as the preparation of all relevant documentation. In March 2020, the application for consistency evaluation was submitted to the National Medical Products Review Center. Following guidance and requirements from the National Review Center and relevant drug regulatory authorities in Guangxi, the team actively supplemented and verified the submitted materials. Ultimately, in February 2021, the company received the official approval document for the drug.
This product is suitable for chronic gastritis and gastric discomfort symptoms related to stomach acid, such as stomach pain, heartburn, acidic belching, and bloating. It marks Baihui Pharmaceutical's first product to pass the consistency evaluation, making Baihui Pharmaceutical the second pharmaceutical manufacturer in Guangxi—after Guilin Nan Yao Co., Ltd.—to achieve this milestone recognized by the national evaluation process. This significant achievement has greatly boosted the enthusiasm of Baihui Pharmaceutical's R&D team and provided valuable experience for conducting consistency evaluation studies on other product lines. Meanwhile, as local Guangxi-based companies, Baihui Pharmaceutical and Guilin Nan Yao have successively passed the national consistency evaluation, effectively elevating the overall standards of Guangxi's pharmaceutical industry and contributing to the high-quality development of Guangxi's pharmaceutical sector.
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