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
Aspen API. More than just an API.
Aspen API. More than just an API.
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Status : Withdrawn by Holder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 Loestrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loestrin, including repackagers and relabelers. The FDA regulates Loestrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loestrin 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 Loestrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loestrin supplier is an individual or a company that provides Loestrin active pharmaceutical ingredient (API) or Loestrin finished formulations upon request. The Loestrin suppliers may include Loestrin API manufacturers, exporters, distributors and traders.
click here to find a list of Loestrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loestrin CEP of the European Pharmacopoeia monograph is often referred to as a Loestrin Certificate of Suitability (COS). The purpose of a Loestrin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Loestrin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Loestrin to their clients by showing that a Loestrin CEP has been issued for it. The manufacturer submits a Loestrin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Loestrin CEP holder for the record. Additionally, the data presented in the Loestrin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Loestrin DMF.
A Loestrin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Loestrin 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 Loestrin suppliers with CEP (COS) on PharmaCompass.
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