01 1HEC Pharm
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-31
Pay. Date : 2020-12-07
DMF Number : 30170
Submission : 2016-01-19
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 SITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 30170.
Remarkably, this DMF maintains an Active status since its submission on January 19, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 31, 2020, and payment made on December 07, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
