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Tianyu Pharmaceutical's API Proline Henggliflozin has been approved by CDE

 Last Update: 2022-01-26
 Source: Internet
 Author: User

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On the evening of January 5, Tianyu Pharmaceutical issued an announcement saying that the API of Proline Henggliflozin had recently passed the CDE technical review
.

Proline constagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, by inhibiting SGLT2, it reduces the reabsorption of glucose filtered by the renal tubules, thereby increasing urinary glucose excretion
.

In June 2020, Tianyu Pharmaceutical submitted a drug registration application for Proline Henggliflozin API to CDE and was accepted
.

According to the announcement on the CDE website, there is only one manufacturer of proline henggliflozin API that has passed the CDE technical review
.

The company's Proline Henggliflozin has completed the GMP compliance inspection, and is currently waiting for the Zhejiang Provincial Food and Drug Administration to announce the results of the GMP compliance inspection for this variety

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