DMF Filing Status (US FDA)

Submission DMF No. Registration Status
Liraglutide 34104 FA Letter received from US-FDA
Semaglutide 36273 FA Letter received from US-FDA
Tirzepatide 39465 US DMF was submitted in 2024
Eptifibatide 23786 Approved by FDA
Bivalirudin 32281 Approved by FDA
Lanreotide Acetate 29693 Approved by FDA
Octreotide Acetate 29710 Approved by FDA
Fulvestrant 33902 Approved by FDA
Cetrorelix acetate 35171 FA Letter received from US-FDA
Desmopressin Acetate 37799 US DMF was submitted in Dec. 2022
Oseltamivir Phosphate 33907 FA Letter received from US-FDA

DMF Filing Status (NMPA)

Submission DMF No. Registration Status
Liraglutide Y20220000633 Under technical review
Semaglutide Y20220001086 Under technical review
Octreotide Acetate Y20180001746 Approved by related authority
Bivalirudin Y20190000290 Approved by related authority
Eptifibatide Y20180001360 Approved by related authority
Fulvestrant Y20200001489 Approved by related authority
Alagliptin benzoate Y20180000506 Approved by related authority
Oseltamivir Phosphate Y20200000736 Approved by related authority
Albuvirtide Y20200001298 Approved by related authority
Thymalfasin Y20170001373 Approved by related authority
Desmopressin Acetate Y20220001250 Under technical review
Cetrorelix acetate Y20220000567 Under technical review
Epalrestat Y20220001175 Under technical review
Atorvastatin calcium Y20210001031 Under technical review
Sodium Picosulfate Y20220000698 Under technical review