01 1HEC Pharm
01 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-08
Pay. Date : 2014-04-09
DMF Number : 27918
Submission : 2014-04-08
Status : Active
Type : II
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Hec Pharm 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 DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 27918.
Remarkably, this DMF maintains an Active status since its submission on April 08, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 08, 2014, and payment made on April 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
