01 1Shandong Keyuan Pharmaceutical
01 1METFORMIN HYDROCHLORIDE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-10
Pay. Date : 2023-07-05
DMF Number : 33876
Submission : 2019-05-16
Status : Active
Type : II
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Shandong Keyuan Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is METFORMIN HYDROCHLORIDE, with a corresponding US DMF Number 33876.
Remarkably, this DMF maintains an Active status since its submission on May 16, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 10, 2023, and payment made on July 05, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
