Zhejiang Tianyu Pharmaceutical's Subsidiary Receives Regulatory Nod for Key Diabetes Ingredient

Stock News

Sep 04

Zhejiang Tianyu Pharmaceutical Co.,Ltd. (300702.SZ) has announced that its wholly-owned subsidiary, Zhejiang Jingsheng Pharmaceutical Co., Ltd., has successfully passed the review conducted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its sitagliptin phosphate active pharmaceutical ingredient (API).

Sitagliptin phosphate is an anti-diabetic medication designed to help control blood glucose levels, primarily used in the management of type 2 diabetes mellitus. This regulatory milestone marks a critical step for the company in advancing its product portfolio within the metabolic disease segment.

While the API has now cleared the CDE review, it is still subject to a compliance inspection by the Zhejiang Provincial Drug Administration, specifically requiring a result of "conforming to requirements" before the product can be commercially distributed for sale within the domestic Chinese market. This final GMP compliance check serves as the last barrier before market entry.

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This regulatory milestone marks a critical step for the company in advancing its product portfolio within the metabolic disease segment.<br><br>While the API has now cleared the CDE review, it is still subject to a compliance inspection by the Zhejiang Provincial Drug Administration, specifically requiring a result of \"conforming to requirements\" before the product can be commercially distributed for sale within the domestic Chinese market. 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(300702.SZ) has announced that its wholly-owned subsidiary, Zhejiang Jingsheng Pharmaceutical Co., Ltd., has successfully passed the review conducted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its sitagliptin phosphate active pharmaceutical ingredient (API).Sitagliptin phosphate is an anti-diabetic medication designed to help control blood glucose levels, primarily used in the management of type 2 diabetes mellitus. This regulatory milestone marks a critical step for the company in advancing its product portfolio within the metabolic disease segment.While the API has now cleared the CDE review, it is still subject to a compliance inspection by the Zhejiang Provincial Drug Administration, specifically requiring a result of \"conforming to requirements\" before the product can be commercially distributed for sale within the domestic Chinese market. 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