COMPANY
HYBIO PHARMACEUTICAL CO LTD
HYBIO PHARMACEUTICAL CO LTD: API manufacturer, bulk ingredient labeler for Abaloparatide, Cetrorelix, Degarelix, Desmopressin, Difelikefalin, Etelcalcetide, Ganirelix, Linaclotide, Liraglutide, Oxytocin, Plecanatide, Retatrutide, Semaglutide, Teriparatide, Tirzepatide, Terlipressin, as stated by public registers.
Also written as: Hybio Pharmaceutical Co., Ltd.; Hybio Pharmaceutical Co. Ltd.; Hybio Pharmaceutical Co. Ltd.
API MANUFACTURER
Filed a drug master file with FDA for the active ingredient.
| Abaloparatide | DMF 39223, type II, active, submitted 2023-11-30 Regulator FDA drug master file list |
|---|---|
| Cetrorelix | DMF 37082, type II, active, submitted 2022-04-29 Regulator FDA drug master file list |
| Degarelix | DMF 38904, type II, active, submitted 2023-09-27 Regulator FDA drug master file list |
| Degarelix | DMF 41697, type II, active, submitted 2025-03-31 Regulator FDA drug master file list |
| Desmopressin | DMF 31889, type II, active, submitted 2017-07-28 Regulator FDA drug master file list |
| Difelikefalin | DMF 42266, type II, active, submitted 2025-12-30 Regulator FDA drug master file list |
| Etelcalcetide | DMF 43734, type II, active, submitted 2026-03-13 Regulator FDA drug master file list |
| Ganirelix | DMF 30800, type II, active, submitted 2016-07-28 Regulator FDA drug master file list |
| Linaclotide | DMF 32314, type II, active, submitted 2017-12-28 Regulator FDA drug master file list |
| Linaclotide | DMF 37370, type II, active, submitted 2022-08-17 Regulator FDA drug master file list |
| Liraglutide | DMF 30095, type II, active, submitted 2015-12-07 Regulator FDA drug master file list |
| Liraglutide | DMF 35364, type II, active, submitted 2020-11-27 Regulator FDA drug master file list |
| Oxytocin | DMF 34916, type II, active, submitted 2020-07-20 Regulator FDA drug master file list |
| Plecanatide | DMF 42062, type II, active, submitted 2025-06-26 Regulator FDA drug master file list |
| Retatrutide | DMF 43577, type II, active, submitted 2026-02-10 Regulator FDA drug master file list |
| Semaglutide | DMF 38443, type II, active, submitted 2023-06-09 Regulator FDA drug master file list |
| Semaglutide | DMF 40319, type II, active, submitted 2024-08-08 Regulator FDA drug master file list |
| Semaglutide | DMF 40534, type II, active, submitted 2024-09-24 Regulator FDA drug master file list |
| Teriparatide | DMF 34388, type II, active, submitted 2019-12-31 Regulator FDA drug master file list |
| Teriparatide | DMF 36502, type II, active, submitted 2021-12-29 Regulator FDA drug master file list |
| Tirzepatide | DMF 40156, type II, active, submitted 2024-06-27 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
Lists the bulk active ingredient with FDA (NDC directory).
| Desmopressin | Desmopressin Acetate, BULK INGREDIENT Regulator openFDA |
|---|---|
| Ganirelix | Ganirelix Acetate, BULK INGREDIENT Regulator openFDA |
| Linaclotide | Linaclotide, BULK INGREDIENT Regulator openFDA |
| Liraglutide | Liraglutide, BULK INGREDIENT Regulator openFDA |
| Oxytocin | Oxytocin, BULK INGREDIENT Regulator openFDA |
| Semaglutide | Semaglutide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA |
| Teriparatide | Teriparatide, BULK INGREDIENT Regulator openFDA |
| Terlipressin | Terlipressin Acetate, BULK INGREDIENT Regulator openFDA |
| Tirzepatide | Tirzepatide, BULK INGREDIENT Regulator openFDA |
| Tirzepatide | Tirzepatide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA |
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