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List of Drug Master Files (DMF) of Cyclosporine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 AbbVie Inc (1)

02 Actavis Inc (1)

03 Apotex Pharmachem (1)

04 CKD Bio Corporation (1)

05 Catalent Pharma Solutions (2)

06 Concord Biotech (1)

07 Curia (2)

08 Fujian Kerui Pharmaceutical Co Ltd (1)

09 GALENA AS (1)

10 Hangzhou Zhongmei Huadong Pharmaceutical (1)

11 North China Pharmaceutical Co., Ltd. (2)

12 North China Pharmaceutical Huasheng Co Ltd (1)

13 Ruibang Laboratories (1)

14 Sandoz B2B (1)

15 Teva API (4)

16 Zhejiang Ruibang Laboratories (2)

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01 CYCLOSPORINE (8)

02 CYCLOSPORINE (NON-STERILE BULK FORM) (1)

03 CYCLOSPORINE 350507 (1)

04 CYCLOSPORINE CRUDE (1)

05 CYCLOSPORINE ID: 741310 (1)

06 CYCLOSPORINE ID: 741710 (1)

07 CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND. (1)

08 CYCLOSPORINE USP (2)

09 CYCLOSPORINE USP (BULK) (1)

10 CYCLOSPORINE USP, NON-STERILE BULK DRUG SUBSTANCE (1)

11 CYCLOSPORINE, NON-STERILE BULK, USP (1)

12 CYCLOSPORINE, USP (BULK, NON-STERILE) (1)

13 CYCLOSPORINE, USP (NON STERILE BULK) (1)

14 NEORAL 25 MG AND 100 MG SOFTGELS (1)

15 SANDIMMUNE 25 MG AND 100 MG SOFTGELS (1)

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01 Canada (1)

02 China (8)

03 Czech Republic (1)

04 India (1)

05 Ireland (1)

06 Israel (4)

07 South Korea (1)

08 Switzerland (1)

09 U.S.A (5)

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01 Active (14)

02 Inactive (9)

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01 Complete (9)

02 Blank (14)

URL Supplier Web Content
13800
Active
1998-09-01
N/A
II
Abbvie Company Banner

Biotechgate Digital

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
13929
Active
1999-01-04
Complete
2014-11-11
2014-05-08
II
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URL Supplier Web Content
12214
Active
1996-10-25
N/A
II
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URL Supplier Web Content
23962
Active
2010-07-08
Complete
2013-09-05
2013-04-08
II
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URL Supplier Web Content
12949
Active
1998-04-13
Complete
2014-01-16
2013-12-02
II
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URL Supplier Web Content
13789
Active
1998-09-01
Complete
2014-01-16
2013-12-12
II
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URL Supplier Web Content
18932
Active
2005-09-06
Complete
2014-03-03
2014-02-19
II
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URL Supplier Web Content
12932
Active
1998-04-02
Complete
2012-11-29
2012-11-07
II
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URL Supplier Web Content
13799
Active
1998-09-01
N/A
II
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28512
Active
2014-12-03
Complete
2015-04-23
2015-01-07
II
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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 USDMF

A Cyclosporine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyclosporine active pharmaceutical ingredient (API) in detail. Different forms of Cyclosporine DMFs exist exist since differing nations have different regulations, such as Cyclosporine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cyclosporine DMF submitted to regulatory agencies in the US is known as a USDMF. Cyclosporine USDMF includes data on Cyclosporine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyclosporine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cyclosporine suppliers with USDMF on PharmaCompass.

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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