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List of Drug Master Files (KDMF) for Fumaderm Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Laboratorium Ofichem BV (2)

02 Laboratorium Ofichem BV@Gesellschaft fur micronislerung mbH (1)

03 Shilpa Pharma Lifesciences Limited@Shilpa Pharma Lifesciences Limited (1)

04 Sigma-Aldrich Production GmbH@[micronization process] Jetpharma SA (1)

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01 Kolon Pharmaceutical Co., Ltd. (3)

02 Korea Eisai Co., Ltd. (1)

03 Masung LS Co., Ltd. (1)

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01 Dimethyl fumarate (micronized) (2)

02 dimethyl fumarate (3)

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01 India (1)

02 Mexico (1)

03 Netherlands (3)

Kolon Pharmaceutical Co., Ltd.
2022-06-21
Number 234-3-ND
Laboratorium Ofichem BV
Netherlands
Heembadweg 5, Ter Apel, 9...
Kolon Pharmaceutical Co., Ltd.
2019-12-30
Number 234-1-ND
Laboratorium Ofichem BV
Netherlands
Heembadweg 5, Ter Apel 95...
Kolon Pharmaceutical Co., Ltd.
2020-04-14
Number 234-2-ND
Laboratorium Ofichem BV@G...
Netherlands
Heembadweg 5, Ter Apel 95...
URL Supplier Web Content
Masung LS Co., Ltd.
2023-01-11
Wed163-29-ND
Shilpa Pharma Lifescience...
India
Plot No. 33, 33A, 40 to 4...
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URL Supplier Web Content
Korea Eisai Co., Ltd.
2016-01-04
Number 4734-4-ND
Sigma-Aldrich Production ...
Mexico
Industriestrasse 25, CH- ...
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Looking for 624-49-7 / Dimethyl Fumarate API manufacturers, exporters & distributors?

Dimethyl Fumarate manufacturers, exporters & distributors 1

92

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

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

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

API | Excipient name

Dimethyl Fumarate

Synonyms

624-49-7, Tecfidera, Dimethylfumarate, Methyl fumarate, (e)-dimethyl fumarate, Fumaderm

Cas Number

624-49-7

Unique Ingredient Identifier (UNII)

FO2303MNI2

About Dimethyl Fumarate

A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.

Fumaderm Manufacturers

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

Fumaderm Suppliers

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

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

Fumaderm KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Fumaderm Drug Master File in Korea (Fumaderm KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fumaderm. The MFDS reviews the Fumaderm KDMF as part of the drug registration process and uses the information provided in the Fumaderm KDMF to evaluate the safety and efficacy of the drug.

After submitting a Fumaderm KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fumaderm API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Fumaderm suppliers with KDMF on PharmaCompass.

Fumaderm Manufacturers | Traders | Suppliers

Fumaderm Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Fumaderm

Get in contact with the supplier of your choice:

  1. Laboratorium Ofichem B.V
  2. Shilpa Medicare
  3. Signa S.A. de C.V.
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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