01 1Amphastar Pharmaceuticals
01 1PROTAMINE SULFATE USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-19
Pay. Date : 2022-10-11
DMF Number : 30429
Submission : 2016-09-16
Status : Active
Type : II
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Amphastar Nanjing Pharmaceuticals Inc (anp) An Amphastar Co, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is PROTAMINE SULFATE USP, with a corresponding US DMF Number 30429.
Remarkably, this DMF maintains an Active status since its submission on September 16, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2022, and payment made on October 11, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
