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List of Korea Drug Master Files (KDMF) for Fedratinib Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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BMS Korea Pharmaceutical Co., Ltd.
2022-04-27
Number 342-18-ND
Changzhou SynTheAll Pharm...
China
No. 589 North Yulong Road...
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Looking for 936091-26-8 / Fedratinib API manufacturers, exporters & distributors?

Fedratinib manufacturers, exporters & distributors 1

85

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

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

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

API | Excipient name

Fedratinib

Synonyms

936091-26-8, Tg-101348, Tg101348, Sar302503, Sar-302503, N-(tert-butyl)-3-((5-methyl-2-((4-(2-(pyrrolidin-1-yl)ethoxy)phenyl)amino)pyrimidin-4-yl)amino)benzenesulfonamide

Cas Number

936091-26-8

Unique Ingredient Identifier (UNII)

6L1XP550I6

About Fedratinib

Fedratinib is an orally bioavailable, small-molecule, ATP-competitive inhibitor of Janus-associated kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3; CD135; STK1; FLK2), with potential antineoplastic activity. Upon oral administration, fedratinib competes with wild-type JAK2 as well as mutated forms for ATP binding, which may result in inhibition of JAK2 activation, inhibition of the JAK-STAT signaling pathway, inhibition of tumor cell proliferation and induction of tumor cell apoptosis. JAK2 is the most commonly mutated gene in bcr-abl-negative myeloproliferative disorders (MPDs). In addition, fedratinib targets, binds to and inhibits the activity of FLT3. This inhibits uncontrolled FLT3 signaling and results in the inhibition of proliferation in tumor cells overexpressing FLT3. FLT3, a class III receptor tyrosine kinase (RTK), is overexpressed or mutated in most B-lineage neoplasms and in acute myeloid leukemias and plays a key role in tumor cell proliferation.

Fedratinib Manufacturers

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

Fedratinib Suppliers

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

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

Fedratinib KDMF

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

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

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

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

Fedratinib Manufacturers | Traders | Suppliers

Fedratinib Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Fedratinib

Get in contact with the supplier of your choice:

  1. Mitsubishi Tanabe Pharma
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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