Aspen API. More than just an API.
01 1ASPEN OSS B.V. Oss NL
02 3BAYER AG Leverkusen DE
03 1VALDEPHARM Val de Reuil FR
04 1ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO., LTD. Xianju CN
05 2ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Xianju CN
01 4Norethisterone
02 1Norethisterone, 202311
03 2Norethisterone, Micronised
04 1Norethisterone, Process II
01 3China
02 1France
03 3Germany
04 1Netherlands
01 7Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 1996-041 - Rev 07
Status : Valid
Issue Date : 2022-11-25
Type : Chemical
Substance Number : 234
Certificate Number : CEP 2023-427 - Rev 00
Status : Valid
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 234
Certificate Number : CEP 2000-110 - Rev 05
Status : Valid
Issue Date : 2023-09-12
Type : Chemical
Substance Number : 234
Certificate Number : R1-CEP 2013-050 - Rev 00
Status : Valid
Issue Date : 2018-07-23
Type : Chemical
Substance Number : 234
Certificate Number : R1-CEP 2011-094 - Rev 03
Status : Valid
Issue Date : 2022-09-05
Type : Chemical
Substance Number : 234
Certificate Number : R1-CEP 2010-158 - Rev 00
Status : Valid
Issue Date : 2016-08-26
Type : Chemical
Substance Number : 234
Certificate Number : R0-CEP 2022-141 - Rev 00
Status : Valid
Issue Date : 2022-07-29
Type : Chemical
Substance Number : 234
Certificate Number : R1-CEP 2010-369 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-03-17
Type : Chemical
Substance Number : 234
A Norethisterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norethisterone, including repackagers and relabelers. The FDA regulates Norethisterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norethisterone 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 Norethisterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norethisterone supplier is an individual or a company that provides Norethisterone active pharmaceutical ingredient (API) or Norethisterone finished formulations upon request. The Norethisterone suppliers may include Norethisterone API manufacturers, exporters, distributors and traders.
click here to find a list of Norethisterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norethisterone CEP of the European Pharmacopoeia monograph is often referred to as a Norethisterone Certificate of Suitability (COS). The purpose of a Norethisterone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norethisterone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norethisterone to their clients by showing that a Norethisterone CEP has been issued for it. The manufacturer submits a Norethisterone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norethisterone CEP holder for the record. Additionally, the data presented in the Norethisterone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norethisterone DMF.
A Norethisterone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norethisterone 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 Norethisterone suppliers with CEP (COS) on PharmaCompass.
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