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Looking for 936091-26-8 / Fedratinib API manufacturers, exporters & distributors?

Fedratinib manufacturers, exporters & distributors 1

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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 hydrochloride Manufacturers

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

fedratinib hydrochloride Suppliers

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

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

fedratinib hydrochloride USDMF

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

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

click here to find a list of fedratinib hydrochloride suppliers with USDMF on PharmaCompass.

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

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

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

fedratinib hydrochloride GMP

fedratinib hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of fedratinib hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right fedratinib hydrochloride GMP manufacturer or fedratinib hydrochloride GMP API supplier for your needs.

fedratinib hydrochloride CoA

A fedratinib hydrochloride CoA (Certificate of Analysis) is a formal document that attests to fedratinib hydrochloride's compliance with fedratinib hydrochloride specifications and serves as a tool for batch-level quality control.

fedratinib hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each fedratinib hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

fedratinib hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (fedratinib hydrochloride EP), fedratinib hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (fedratinib hydrochloride USP).

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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