01 1HEC Pharm
01 1SOLIFENACIN SUCCINATE NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-28
Pay. Date : 2020-09-17
DMF Number : 35140
Submission : 2020-08-28
Status : Active
Type : II
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Ruyuan 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 SOLIFENACIN SUCCINATE NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 35140.
Remarkably, this DMF maintains an Active status since its submission on August 28, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2020, and payment made on September 17, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
