01 1Shouguang Fukang Pharmaceutical Co., Ltd
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-02
Pay. Date : 2015-01-06
DMF Number : 28548
Submission : 2014-07-03
Status : Active
Type : II
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Shouguang Fukang Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, with a corresponding US DMF Number 28548.
Remarkably, this DMF maintains an Active status since its submission on July 03, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 02, 2015, and payment made on January 06, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
