01 1Lunan Pharmaceutical
01 1SITAGLIPTIN PHOSPHATE USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-04
Pay. Date : 2022-06-08
DMF Number : 36470
Submission : 2022-05-18
Status : Active
Type : II
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Shandong New Time Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is SITAGLIPTIN PHOSPHATE USP, with a corresponding US DMF Number 36470.
Remarkably, this DMF maintains an Active status since its submission on May 18, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2022, and payment made on June 08, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
