01 1AbbVie Inc. North Chicago US
02 1TEVA CZECH INDUSTRIES S.R.O. Opava CZ
03 1TEVA PHARMACEUTICAL INDUSTRIES LTD Petach Tikva IL
04 1Apotex Fermentation Inc. Winnipeg CA
05 1CKD BIO CORPORATION Ansan-si KR
06 1CONCORD BIOTECH LIMITED Ahmedabad IN
07 1CURIA ITALY S.R.L. Rozzano, Milano IT
08 1HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN
09 1North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN
10 1TAISHAN CITY CHEMICAL PHARMACEUTICAL CO., LTD. Taishan City CN
11 1Zhejiang Ruibang Laboratories Wenzhou CN
01 11Ciclosporin
01 1Canada
02 4China
03 1India
04 2Israel
05 1South Korea
06 2U.S.A
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
Certificate Number : R1-CEP 1998-093 - Rev 07
Status : Valid
Issue Date : 2020-10-09
Type : Chemical and TSE
Substance Number : 994
Certificate Number : R1-CEP 2002-152 - Rev 06
Status : Valid
Issue Date : 2023-06-21
Type : Chemical
Substance Number : 994
Certificate Number : R1-CEP 1997-045 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2017-11-02
Type : Chemical
Substance Number : 994
Certificate Number : R0-CEP 2015-367 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-11-27
Type : Chemical
Substance Number : 994
Certificate Number : R1-CEP 2007-251 - Rev 02
Status : Valid
Issue Date : 2021-08-26
Type : Chemical
Substance Number : 994
Certificate Number : R1-CEP 2010-214 - Rev 03
Status : Valid
Issue Date : 2022-10-17
Type : Chemical
Substance Number : 994
Certificate Number : R1-CEP 1999-034 - Rev 06
Status : Valid
Issue Date : 2021-08-30
Type : Chemical
Substance Number : 994
Certificate Number : CEP 2003-105 - Rev 03
Status : Valid
Issue Date : 2024-06-19
Type : Chemical and TSE
Substance Number : 994
Certificate Number : CEP 2021-399 - Rev 00
Status : Valid
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 994
Certificate Number : R0-CEP 2020-144 - Rev 00
Status : Valid
Issue Date : 2023-04-20
Type : Chemical and TSE
Substance Number : 994
A Cyclosporine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclosporine, including repackagers and relabelers. The FDA regulates Cyclosporine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclosporine 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 Cyclosporine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyclosporine supplier is an individual or a company that provides Cyclosporine active pharmaceutical ingredient (API) or Cyclosporine finished formulations upon request. The Cyclosporine suppliers may include Cyclosporine API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclosporine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cyclosporine CEP of the European Pharmacopoeia monograph is often referred to as a Cyclosporine Certificate of Suitability (COS). The purpose of a Cyclosporine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cyclosporine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cyclosporine to their clients by showing that a Cyclosporine CEP has been issued for it. The manufacturer submits a Cyclosporine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cyclosporine CEP holder for the record. Additionally, the data presented in the Cyclosporine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cyclosporine DMF.
A Cyclosporine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cyclosporine 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 Cyclosporine suppliers with CEP (COS) on PharmaCompass.
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