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List of Drug Master Files (KDMF) for Dimethyl Fumarate 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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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.

Dimethyl Fumarate Manufacturers

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

Dimethyl Fumarate Suppliers

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

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

Dimethyl Fumarate KDMF

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

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

After submitting a Dimethyl Fumarate 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 Dimethyl Fumarate API can apply through the Korea Drug Master File (KDMF).

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

Dimethyl Fumarate Manufacturers | Traders | Suppliers

Dimethyl Fumarate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Dimethyl Fumarate

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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