Zhejiang Tianyu Pharmaceutical Co Ltd300702
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API passed CDE review but still needs GMP compliance and market launch timing uncertain
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Zhejiang Tianyu Pharmaceutical Co LtdZhejiang Tianyu Pharmaceutical announced that its brexpiprazole active pharmaceutical ingredient has recently passed the review of the Center for Drug Evaluation of the National Medical Products Administration and obtained registration approval. The API registration number is Y20240001143, and it is indicated for the treatment of schizophrenia in adults. Currently, a total of 21 manufacturers in China have passed the CDE technical review, including Tianyu Pharma. The company stated that the API still needs to obtain a GMP compliance inspection result of "compliant" from the Zhejiang Medical Products Administration before it can be marketed and sold in China. The application is currently being prepared, and the timing of market launch remains uncertain.
Zhejiang Tianyu Pharmaceutical Co LtdAPI passed CDE review but still needs GMP compliance and market launch timing uncertain