01 1HEC Pharm
01 1AZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-09
Pay. Date : 2014-12-30
DMF Number : 28837
Submission : 2014-10-31
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 AZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM, with a corresponding US DMF Number 28837.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 09, 2015, and payment made on December 30, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
