01 1BAYER AG Leverkusen DE
02 1GEDEON RICHTER PLC Budapest HU
03 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd. E-Zhou CN
04 1Industriale Chimica S.R.L. Saronno IT
05 1Jenapharm GmbH & Co KG Jena DE
06 1LUPIN LIMITED Mumbai IN
07 3QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN
08 2STERLING CHEMICAL MALTA LTD. Birzebbugia MT
01 6Levonorgestrel
02 1Levonorgestrel, Micro 20
03 1Levonorgestrel, Micronised
04 1Levonorgestrel, Micronised, Process II
05 1Levonorgestrel, Micronised, code 200318
06 1Levonorgestrel, Non-micronised and micronised
01 4China
02 2Germany
03 1Hungary
04 1India
05 3Italy
01 9Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
Certificate Number : R1-CEP 2000-101 - Rev 03
Status : Valid
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 1999-141 - Rev 04
Status : Valid
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 926
Levonorgestrel, Non-micronised And Micronised
Certificate Number : R0-CEP 2022-199 - Rev 00
Status : Valid
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 926
Certificate Number : CEP 2003-127 - Rev 03
Status : Valid
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 926
Certificate Number : CEP 2012-349 - Rev 01
Status : Valid
Issue Date : 2024-09-13
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 2013-237 - Rev 00
Status : Valid
Issue Date : 2019-04-30
Type : Chemical
Substance Number : 926
Levonorgestrel, Micronised, Process II
Certificate Number : R0-CEP 2022-225 - Rev 00
Status : Valid
Issue Date : 2022-12-20
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 2006-218 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2014-02-27
Type : Chemical
Substance Number : 926
Levonorgestrel, Micronised, Code 200318
Certificate Number : R0-CEP 2021-255 - Rev 01
Status : Valid
Issue Date : 2023-06-16
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 2015-056 - Rev 00
Status : Valid
Issue Date : 2023-02-07
Type : Chemical
Substance Number : 926
A Norgestrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norgestrel, including repackagers and relabelers. The FDA regulates Norgestrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norgestrel 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 Norgestrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norgestrel supplier is an individual or a company that provides Norgestrel active pharmaceutical ingredient (API) or Norgestrel finished formulations upon request. The Norgestrel suppliers may include Norgestrel API manufacturers, exporters, distributors and traders.
click here to find a list of Norgestrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norgestrel CEP of the European Pharmacopoeia monograph is often referred to as a Norgestrel Certificate of Suitability (COS). The purpose of a Norgestrel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norgestrel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norgestrel to their clients by showing that a Norgestrel CEP has been issued for it. The manufacturer submits a Norgestrel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norgestrel CEP holder for the record. Additionally, the data presented in the Norgestrel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norgestrel DMF.
A Norgestrel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norgestrel 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 Norgestrel suppliers with CEP (COS) on PharmaCompass.
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