01 1GADOR S.A. Pilar AR
02 1GEDEON RICHTER PLC Budapest HU
03 1Industriale Chimica S.R.L. Saronno IT
04 3STERLING S.p.A. Solomeo Di Corciano IT
01 4Norgestimate
02 1Norgestimate, Optimised process SM-ROS-2, code 200448
03 1Norgestimate, Optimized process
01 1Argentina
02 1Hungary
03 4Italy
01 1Expired
02 5Valid
Certificate Number : R0-CEP 2010-012 - Rev 00
Status : Expired
Issue Date : 2011-11-17
Type : Chemical
Substance Number : 1732
Certificate Number : R1-CEP 2009-125 - Rev 01
Status : Valid
Issue Date : 2021-12-02
Type : Chemical
Substance Number : 1732
Certificate Number : CEP 2017-189 - Rev 01
Status : Valid
Issue Date : 2023-09-28
Type : Chemical
Substance Number : 1732
Certificate Number : R1-CEP 2009-305 - Rev 00
Status : Valid
Issue Date : 2016-11-29
Type : Chemical
Substance Number : 1732
Norgestimate, Optimised Process SM-ROS-2, Code 2...
Certificate Number : CEP 2023-354 - Rev 00
Status : Valid
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 1732
Norgestimate, Optimized Process
Certificate Number : R0-CEP 2021-049 - Rev 02
Status : Valid
Issue Date : 2022-10-10
Type : Chemical
Substance Number : 1732
A Norgestimate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norgestimate, including repackagers and relabelers. The FDA regulates Norgestimate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norgestimate 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 Norgestimate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norgestimate supplier is an individual or a company that provides Norgestimate active pharmaceutical ingredient (API) or Norgestimate finished formulations upon request. The Norgestimate suppliers may include Norgestimate API manufacturers, exporters, distributors and traders.
click here to find a list of Norgestimate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norgestimate CEP of the European Pharmacopoeia monograph is often referred to as a Norgestimate Certificate of Suitability (COS). The purpose of a Norgestimate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norgestimate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norgestimate to their clients by showing that a Norgestimate CEP has been issued for it. The manufacturer submits a Norgestimate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norgestimate CEP holder for the record. Additionally, the data presented in the Norgestimate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norgestimate DMF.
A Norgestimate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norgestimate 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 Norgestimate suppliers with CEP (COS) on PharmaCompass.
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