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

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01 Kashima Plant, Eisai Co., Ltd. (1)

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01 Korea Eisai Co., Ltd. (1)

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01 Eribulin Mesylate (1)

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01 Japan (1)

URL Supplier Web Content
Korea Eisai Co., Ltd.
2012-08-09
Number 3834-1-ND
Kashima Plant, Eisai Co.,...
Japan
22 Sunayama, Kamisu-shi, ...
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Looking for 441045-17-6 / Eribulin API manufacturers, exporters & distributors?

Eribulin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Eribulin

Synonyms

Halaven, Eribulin mesilate, 441045-17-6, Eribulin (mesylate), Eribulin mesylate [usan], Eribulin (as mesylate)

Cas Number

441045-17-6

Unique Ingredient Identifier (UNII)

AV9U0660CW

About Eribulin

Eribulin Mesylate is the mesylate salt of a synthetic analogue of halichondrin B, a substance derived from a marine sponge (Lissodendoryx sp.) with antineoplastic activity. Eribulin binds to the vinca domain of tubulin and inhibits the polymerization of tubulin and the assembly of microtubules, resulting in inhibition of mitotic spindle assembly, induction of cell cycle arrest at G2/M phase, and, potentially, tumor regression.

Eribulin Manufacturers

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

Eribulin Suppliers

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

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

Eribulin KDMF

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

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

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

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

Eribulin Manufacturers | Traders | Suppliers

Eribulin Manufacturers, Traders, Suppliers 1
88

We have 1 companies offering Eribulin

Get in contact with the supplier of your choice:

  1. Eisai
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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