01 1GEDEON RICHTER PLC Budapest HU
02 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd. Ezhou City CN
03 1Industriale Chimica S.R.L. Saronno IT
04 1NEWCHEM S.p.A. Milano IT
05 1QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN
06 1STERLING S.p.A. Solomeo Di Corciano IT
01 2Dienogest
02 3Dienogest, Micronised
03 1Dienogest, Micronised, non-micronised
01 2China
02 1Hungary
03 3Italy
01 6Valid
Certificate Number : R0-CEP 2020-023 - Rev 00
Status : Valid
Issue Date : 2022-05-03
Type : Chemical
Substance Number : 2732
Certificate Number : CEP 2023-045 - Rev 00
Status : Valid
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 2732
Certificate Number : R1-CEP 2016-333 - Rev 00
Status : Valid
Issue Date : 2023-01-20
Type : Chemical
Substance Number : 2732
Dienogest, Micronised, Non-micronised
Certificate Number : CEP 2016-155 - Rev 01
Status : Valid
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 2732
Certificate Number : CEP 2023-376 - Rev 00
Status : Valid
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 2732
Certificate Number : R1-CEP 2016-158 - Rev 00
Status : Valid
Issue Date : 2023-08-02
Type : Chemical
Substance Number : 2732
A Dienogest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dienogest, including repackagers and relabelers. The FDA regulates Dienogest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dienogest 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 Dienogest manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dienogest supplier is an individual or a company that provides Dienogest active pharmaceutical ingredient (API) or Dienogest finished formulations upon request. The Dienogest suppliers may include Dienogest API manufacturers, exporters, distributors and traders.
click here to find a list of Dienogest suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dienogest CEP of the European Pharmacopoeia monograph is often referred to as a Dienogest Certificate of Suitability (COS). The purpose of a Dienogest CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dienogest EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dienogest to their clients by showing that a Dienogest CEP has been issued for it. The manufacturer submits a Dienogest CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dienogest CEP holder for the record. Additionally, the data presented in the Dienogest CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dienogest DMF.
A Dienogest CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dienogest 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 Dienogest suppliers with CEP (COS) on PharmaCompass.
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