COMPANY
POLYPEPTIDE LABORATORIES SWEDEN AB
POLYPEPTIDE LABORATORIES SWEDEN AB: API manufacturer, bulk ingredient labeler for Calcitonin, Desmopressin, Exenatide, Leuprolide, Linaclotide, Octreotide, Terlipressin, Vasopressin, Degarelix, as stated by public registers.
Also written as: Polypeptide Laboratories (Sweden) AB; PolyPeptide Laboratories (Sweden) AB.
API MANUFACTURER
Filed a drug master file with FDA for the active ingredient.
| Calcitonin | DMF 15684, type II, active, submitted 2001-10-19 Regulator FDA drug master file list |
|---|---|
| Desmopressin | DMF 23676, type II, active, submitted 2010-04-02 Regulator FDA drug master file list |
| Desmopressin | DMF 8396, type II, active, submitted 1990-01-26 Regulator FDA drug master file list |
| Exenatide | DMF 27714, type II, active, submitted 2014-01-13 Regulator FDA drug master file list |
| Exenatide | DMF 30924, type II, active, submitted 2016-09-28 Regulator FDA drug master file list |
| Leuprolide | DMF 26832, type II, active, submitted 2013-02-20 Regulator FDA drug master file list |
| Linaclotide | DMF 25021, type II, active, submitted 2011-06-01 Regulator FDA drug master file list |
| Octreotide | DMF 32863, type II, active, submitted 2018-06-18 Regulator FDA drug master file list |
| Terlipressin | DMF 25589, type II, inactive, submitted 2011-12-21 Regulator FDA drug master file list |
| Terlipressin | DMF 34391, type II, active, submitted 2019-12-06 Regulator FDA drug master file list |
| Vasopressin | DMF 27577, type II, inactive, submitted 2013-12-19 Regulator FDA drug master file list |
| Vasopressin | DMF 32116, type II, active, submitted 2017-10-03 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
Lists the bulk active ingredient with FDA (NDC directory).
| Calcitonin | CALCITONIN SALMON, BULK INGREDIENT Regulator openFDA |
|---|---|
| Degarelix | DEGARELIX, BULK INGREDIENT Regulator openFDA |
| Desmopressin | Desmopressin Acetate, BULK INGREDIENT Regulator openFDA |
| Desmopressin | DESMOPRESSIN, BULK INGREDIENT Regulator openFDA |
| Exenatide | Exenatide, BULK INGREDIENT Regulator openFDA |
| Terlipressin | Terlipressin, BULK INGREDIENT Regulator openFDA |
| Vasopressin | Vasopressin, BULK INGREDIENT Regulator openFDA |
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