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List of Certificates of Suitability (CEPs) for Cyclosporine Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 AbbVie Inc. North Chicago US (1)

02 Apotex Fermentation Inc. Winnipeg CA (1)

03 CKD BIO CORPORATION Ansan-si KR (1)

04 CONCORD BIOTECH LIMITED Ahmedabad IN (1)

05 CURIA ITALY S.R.L. Rozzano, Milano IT (1)

06 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Hangzhou CN (1)

07 North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN (1)

08 TAISHAN CITY CHEMICAL PHARMACEUTICAL CO., LTD. Taishan City CN (1)

09 TEVA CZECH INDUSTRIES S.R.O. Opava CZ (1)

10 TEVA PHARMACEUTICAL INDUSTRIES LTD Petach Tikva IL (1)

11 Zhejiang Ruibang Laboratories Wenzhou CN (1)

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01 Ciclosporin (11)

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01 Canada (1)

02 China (4)

03 India (1)

04 Israel (2)

05 South Korea (1)

06 U.S.A (2)

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01 Valid (8)

02 Withdrawn by EDQM Failure to CEP procedure (1)

03 Withdrawn by Holder (2)

URL Supplier Web Content
R1-CEP 1998-093 - Rev 07
Valid
Chemical and TSE
2020-10-09
994
Abbvie Company Banner

Biotechgate Digital

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
R0-CEP 2015-367 - Rev 00
Withdrawn by Holder
Chemical
2017-11-27
2019-09-24
994
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R1-CEP 2007-251 - Rev 02
Valid
Chemical
2021-08-26
994
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R1-CEP 2010-214 - Rev 03
Valid
Chemical
2022-10-17
994
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R1-CEP 1999-034 - Rev 06
Valid
Chemical
2021-08-30
994
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R1-CEP 2003-105 - Rev 02
Valid
Chemical and TSE
2023-01-16
994
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CEP 2021-399 - Rev 00
Valid
Chemical
2024-02-20
994
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R1-CEP 2002-152 - Rev 06
Valid
Chemical
2023-06-21
994
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R1-CEP 1997-045 - Rev 05
Withdrawn by Holder
Chemical
2017-11-02
2021-08-12
994
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R0-CEP 2020-144 - Rev 00
Valid
Chemical and TSE
2023-04-20
994
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Looking for 59865-13-3 / Cyclosporine API manufacturers, exporters & distributors?

Cyclosporine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cyclosporine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cyclosporine manufacturer or Cyclosporine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cyclosporine manufacturer or Cyclosporine supplier.

PharmaCompass also assists you with knowing the Cyclosporine API Price utilized in the formulation of products. Cyclosporine API Price is not always fixed or binding as the Cyclosporine Price is obtained through a variety of data sources. The Cyclosporine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cyclosporine

Synonyms

Ciclosporin, 59865-13-3, Cyclosporine a, Sandimmune, Neoral, Sandimmun

Cas Number

59865-13-3

Unique Ingredient Identifier (UNII)

83HN0GTJ6D

About Cyclosporine

A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).

Cyclosporine Manufacturers

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.

Cyclosporine Suppliers

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.

Cyclosporine CEP

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.

Cyclosporine Manufacturers | Traders | Suppliers

Cyclosporine Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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