01 1Bayer AG
02 1CHEMO
03 2Gedeon Richter
04 1Guangzhou Tosun Pharmaceutical
05 1Hangzhou Deli Chemical
06 1Hangzhou Longshine Bio-Tech
07 1Industriale Chimica
08 1LABORATOIRE THERAMEX
09 1LIBBS FARMO QUIMICA LTDA
10 1NEWCHEM SPA
11 1Qinhuangdao Zizhu Pharmaceutical
12 1Swati Spentose
01 1Brazil
02 4China
03 1Germany
04 2Hungary
05 1India
06 2Italy
07 1Monaco
08 1Spain
01 1Active
02 1Inactive
03 11Blank
01 1Expired
02 6Valid
03 1Withdrawn by Holder
04 5Blank
01 13Blank
01 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29345
Submission : 2015-06-08
Status : Active
Type : II
Certificate Number : R1-CEP 2015-160 - Rev 00
Issue Date : 2022-01-19
Type : Chemical
Substance Number : 1726
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6174
Submission : 1985-12-19
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-345 - Rev 01
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 1726
Status : Valid
Certificate Number : R0-CEP 2010-135 - Rev 00
Issue Date : 2011-08-23
Type : Chemical
Substance Number : 1726
Status : Expired
Certificate Number : R1-CEP 2009-403 - Rev 01
Issue Date : 2020-01-31
Type : Chemical
Substance Number : 1726
Status : Valid
Certificate Number : R1-CEP 2011-026 - Rev 01
Issue Date : 2020-01-31
Type : Chemical
Substance Number : 1726
Status : Valid
Certificate Number : R1-CEP 2009-181 - Rev 01
Issue Date : 2020-05-15
Type : Chemical
Substance Number : 1726
Status : Valid
NDC Package Code : 63190-0550
Start Marketing Date : 2014-12-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2020-174 - Rev 02
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 1726
Status : Valid
Certificate Number : R1-CEP 2009-240 - Rev 01
Issue Date : 2018-04-27
Type : Chemical
Substance Number : 1726
Status : Withdrawn by Holder
A Gestodene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gestodene, including repackagers and relabelers. The FDA regulates Gestodene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gestodene API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Gestodene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gestodene supplier is an individual or a company that provides Gestodene active pharmaceutical ingredient (API) or Gestodene finished formulations upon request. The Gestodene suppliers may include Gestodene API manufacturers, exporters, distributors and traders.
click here to find a list of Gestodene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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