COMPANY

ALP PHARM BEIJING CO LTD

ALP PHARM BEIJING CO LTD: API manufacturer for Bacitracin, Cetrorelix, Difelikefalin, Exenatide, Goserelin, Lanreotide, Leuprolide, Liraglutide, Octreotide, Plecanatide, Semaglutide, Teduglutide, Tirzepatide, as stated by public registers.

API MANUFACTURER

Filed a drug master file with FDA for the active ingredient.

BacitracinDMF 23999, type II, active, submitted 2010-07-02 Regulator FDA drug master file list
BacitracinDMF 24000, type II, active, submitted 2010-07-02 Regulator FDA drug master file list
CetrorelixDMF 33914, type II, active, submitted 2019-06-05 Regulator FDA drug master file list
DifelikefalinDMF 38645, type II, active, submitted 2023-08-02 Regulator FDA drug master file list
ExenatideDMF 35476, type II, active, submitted 2020-12-15 Regulator FDA drug master file list
GoserelinDMF 29713, type II, active, submitted 2015-09-10 Regulator FDA drug master file list
LanreotideDMF 24378, type II, active, submitted 2010-11-05 Regulator FDA drug master file list
LeuprolideDMF 34847, type II, active, submitted 2020-04-28 Regulator FDA drug master file list
LiraglutideDMF 29711, type II, active, submitted 2015-09-10 Regulator FDA drug master file list
OctreotideDMF 30992, type II, active, submitted 2016-10-26 Regulator FDA drug master file list
PlecanatideDMF 35439, type II, active, submitted 2020-12-08 Regulator FDA drug master file list
SemaglutideDMF 35875, type II, active, submitted 2021-04-22 Regulator FDA drug master file list
TeduglutideDMF 35438, type II, active, submitted 2020-12-08 Regulator FDA drug master file list
TirzepatideDMF 38773, type II, active, submitted 2023-08-30 Regulator FDA drug master file list

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