01 1HEC Pharm
01 1FINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-17
Pay. Date : 2014-04-15
DMF Number : 28165
Submission : 2014-04-23
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 FINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 28165.
Remarkably, this DMF maintains an Active status since its submission on April 23, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 17, 2014, and payment made on April 15, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
