01 1BAYER AG Leverkusen DE
02 2GEDEON RICHTER PLC Budapest HU
03 1Industriale Chimica S.R.L. Saronno IT
04 1LABORATOIRE THERAMEX Monaco MC
05 1LIBBS FARMACEUTICA LTDA. Embu das Artes BR
06 1NEWCHEM S.p.A. Milano IT
07 1QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN
01 1Gestodene
02 1Gestodene, Crystallised
03 4Gestodene, Micronised
04 1Gestodene, Micronised (micro 20)
05 1Gestodene, micronised and non-micronised
01 1Brazil
02 1China
03 1Germany
04 2Hungary
05 2Italy
06 1Monaco
01 1Expired
02 6Valid
03 1Withdrawn by Holder
Gestodene, Micronised (micro 20)
Certificate Number : R1-CEP 2009-345 - Rev 01
Status : Valid
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 1726
Certificate Number : R1-CEP 2009-403 - Rev 01
Status : Valid
Issue Date : 2020-01-31
Type : Chemical
Substance Number : 1726
Certificate Number : R1-CEP 2011-026 - Rev 01
Status : Valid
Issue Date : 2020-01-31
Type : Chemical
Substance Number : 1726
Certificate Number : R1-CEP 2009-181 - Rev 01
Status : Valid
Issue Date : 2020-05-15
Type : Chemical
Substance Number : 1726
Gestodene, Micronised And Non-micronised
Certificate Number : R0-CEP 2010-135 - Rev 00
Status : Expired
Issue Date : 2011-08-23
Type : Chemical
Substance Number : 1726
Certificate Number : R1-CEP 2009-240 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-04-27
Type : Chemical
Substance Number : 1726
Certificate Number : R0-CEP 2020-174 - Rev 02
Status : Valid
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 1726
Certificate Number : R1-CEP 2015-160 - Rev 00
Status : Valid
Issue Date : 2022-01-19
Type : Chemical
Substance Number : 1726
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.
A Gestodene CEP of the European Pharmacopoeia monograph is often referred to as a Gestodene Certificate of Suitability (COS). The purpose of a Gestodene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gestodene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gestodene to their clients by showing that a Gestodene CEP has been issued for it. The manufacturer submits a Gestodene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gestodene CEP holder for the record. Additionally, the data presented in the Gestodene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gestodene DMF.
A Gestodene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gestodene CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Gestodene suppliers with CEP (COS) on PharmaCompass.
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