01 1JILIN ASYMCHEM LABORATORIES CO LTD
01 1ERTAPENEM SODIUM
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-18
Pay. Date : 2025-05-30
DMF Number : 37463
Submission : 2023-03-02
Status : Active
Type : II
20
Jilin Asymchem Pharmaceuticals Co Ltd, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ERTAPENEM SODIUM, with a corresponding US DMF Number 37463.
Remarkably, this DMF maintains an Active status since its submission on March 02, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 18, 2025, and payment made on May 30, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
