COMPANY

POLYPEPTIDE LABORATORIES INC

POLYPEPTIDE LABORATORIES INC: API manufacturer, bulk ingredient labeler for Leuprolide, Linaclotide, Liraglutide, Octreotide, Teduglutide, Teriparatide, as stated by public registers.

Also written as: Polypeptide Laboratories Inc.

API MANUFACTURER

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

LeuprolideDMF 13150, type II, active, submitted 1998-08-21 Regulator FDA drug master file list
LinaclotideDMF 25025, type II, active, submitted 2011-06-07 Regulator FDA drug master file list
LiraglutideDMF 35860, type II, active, submitted 2021-06-24 Regulator FDA drug master file list
OctreotideDMF 14994, type II, active, submitted 2000-08-04 Regulator FDA drug master file list
OctreotideDMF 21704, type II, inactive, submitted 2008-06-13 Regulator FDA drug master file list

BULK INGREDIENT LABELER

Lists the bulk active ingredient with FDA (NDC directory).

Linaclotidelinaclotide, BULK INGREDIENT Regulator openFDA
LiraglutideLIRAGLUTIDE, BULK INGREDIENT Regulator openFDA
TeduglutideTeduglutide, BULK INGREDIENT Regulator openFDA
TeriparatideTeriparatide, BULK INGREDIENT Regulator openFDA

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