01 1Amphastar Pharmaceuticals
01 1TERIPARATIDE USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-09
Pay. Date : 2019-05-17
DMF Number : 33857
Submission : 2019-05-19
Status : Active
Type : II
20
Amphastar Nanjing Pharmaceuticals Inc, 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 TERIPARATIDE USP, with a corresponding US DMF Number 33857.
Remarkably, this DMF maintains an Active status since its submission on May 19, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 09, 2019, and payment made on May 17, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
