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List of Drug Master Files (DMF) of Selpercatinib Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 MSN Laboratories (1)

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01 SELPERCATINIB (1)

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38833
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2023-09-27
Complete
2023-11-09
2023-09-27
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Looking for 2152628-33-4 / Selpercatinib API manufacturers, exporters & distributors?

Selpercatinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Selpercatinib

Synonyms

2152628-33-4, Loxo-292, Retevmo, Selpercatinib [inn], Cegm9ybngd, Selpercatinib [usan]

Cas Number

2152628-33-4

Unique Ingredient Identifier (UNII)

CEGM9YBNGD

About Selpercatinib

Selpercatinib is an orally bioavailable selective inhibitor of wild-type, mutant and fusion products involving the proto-oncogene receptor tyrosine kinase rearranged during transfection (RET), with potential antineoplastic activity. Upon oral administration, selpercatinib selectively binds to and targets wild-type RET as well as various RET mutants and RET-containing fusion products. This results in an inhibition of cell growth of tumors cells that exhibit increased RET activity. In addition, selpercatinib targets, binds to and inhibits vascular endothelial growth factor receptor 1 (VEGFR1) and 3 (VEGFR3), and fibroblast growth factor receptor 1 (FGFR1), 2 (FGFR2), and 3 (FGFR3). RET overexpression, activating mutations, and fusions result in the upregulation and/or overactivation of RET tyrosine kinase activity in various cancer cell types; dysregulation of RET activity plays a key role in the development and progression of these cancers.

Selpercatinib Manufacturers

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

Selpercatinib Suppliers

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

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

Selpercatinib USDMF

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

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

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

Selpercatinib Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. MSN Laboratories
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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