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

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01 Axplora (1)

02 Megafine Pharma (P) Limited (1)

03 Alembic Pharmaceuticals Limited (1)

04 Aurobindo Pharma Limited (1)

05 Biocon (1)

06 Emcure Pharmaceuticals (1)

07 Formosa Laboratories (1)

08 Glenmark Life Sciences (1)

09 HONOUR LAB LTD (1)

10 Intas Pharmaceuticals (1)

11 MSN Laboratories (1)

12 Maprimed S.A. (1)

13 Natco Pharma (1)

14 Olon S.p.A (1)

15 Optimus Pharma (2)

16 Raks Pharma (1)

17 Shilpa Medicare (1)

18 Tianjin Weijie Pharmaceutical Co., Ltd. (1)

19 Unichem Laboratories Limited (1)

20 Zydus Lifesciences (1)

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01 5-METHYL-ISOXAZOLE-4-CARBOXYLIC ACID (TERIFLUNOMIDE INTERMEDIATE) (1)

02 TERIFLUNOMIDE (18)

03 TERIFLUNOMIDE DRUG SUBSTANCE (1)

04 TERIFLUNOMIDE [ROUTE CODE "TO"] (1)

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01 Argentina (1)

02 China (1)

03 Germany (1)

04 India (16)

05 Italy (1)

06 Taiwan (1)

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01 Active (21)

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01 Complete (18)

02 Blank (3)

30220
Active
2016-03-10
Complete
2016-06-03
2016-02-19
II
Axplora CB

Chinaplas 2024

Not Confirmed

envelop Contact Supplier
29802
Active
2015-09-29
Complete
2016-02-05
2015-09-24
II
Megafine Pharma CB

Cophex 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
28898
Active
2016-03-16
Complete
2016-04-06
2016-02-22
II
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URL Supplier Web Content
29862
Active
2015-12-30
Complete
2016-06-03
2016-01-28
II
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URL Supplier Web Content
28991
Active
2015-03-20
Complete
2015-05-19
2015-03-20
II
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URL Supplier Web Content
29701
Active
2015-10-01
Complete
2015-11-06
2015-09-08
II
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URL Supplier Web Content
27860
Active
2014-01-29
Complete
2015-11-13
2015-09-23
II
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URL Supplier Web Content
29825
Active
2015-09-18
N/A
II
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URL Supplier Web Content
29851
Active
2015-10-21
Complete
2015-12-16
2015-10-16
II
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URL Supplier Web Content
29705
Active
2015-09-29
Complete
2016-03-23
2015-09-22
II
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Looking for 108605-62-5 / Teriflunomide API manufacturers, exporters & distributors?

Teriflunomide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Teriflunomide 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 Teriflunomide manufacturer or Teriflunomide supplier for your needs.

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

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

API | Excipient name

Teriflunomide

Synonyms

163451-81-8, 108605-62-5, Aubagio, Flucyamide, A77 1726, Hmr1726

Cas Number

108605-62-5

Unique Ingredient Identifier (UNII)

1C058IKG3B

About Teriflunomide

Teriflunomide is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using teriflunomide.

Teriflunomide Manufacturers

A Teriflunomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teriflunomide, including repackagers and relabelers. The FDA regulates Teriflunomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teriflunomide 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 Teriflunomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Teriflunomide Suppliers

A Teriflunomide supplier is an individual or a company that provides Teriflunomide active pharmaceutical ingredient (API) or Teriflunomide finished formulations upon request. The Teriflunomide suppliers may include Teriflunomide API manufacturers, exporters, distributors and traders.

click here to find a list of Teriflunomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Teriflunomide USDMF

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

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

click here to find a list of Teriflunomide 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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