01 1Amgen Inc
01 1AMG 157 (TEZEPELUMAB) PHASE 3 CMC AMENDMENT (DRUG SUBSTANCE AND DRUG PRODUCT)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31671
Submission : 2017-08-21
Status : Active
Type : II
20
Amgen 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 AMG 157 (TEZEPELUMAB) PHASE 3 CMC AMENDMENT (DRUG SUBSTANCE AND DRUG PRODUCT), with a corresponding US DMF Number 31671.
Remarkably, this DMF maintains an Active status since its submission on August 21, 2017, highlighting commitment to regulatory compliance.
