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01 1NUSINERSEN
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01 1Active
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41707
Submission : 2025-03-28
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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PharmaCompass offers a list of Nusinersen 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 Nusinersen manufacturer or Nusinersen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nusinersen manufacturer or Nusinersen supplier.
PharmaCompass also assists you with knowing the Nusinersen API Price utilized in the formulation of products. Nusinersen API Price is not always fixed or binding as the Nusinersen Price is obtained through a variety of data sources. The Nusinersen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nusinersen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nusinersen, including repackagers and relabelers. The FDA regulates Nusinersen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nusinersen 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 Nusinersen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nusinersen supplier is an individual or a company that provides Nusinersen active pharmaceutical ingredient (API) or Nusinersen finished formulations upon request. The Nusinersen suppliers may include Nusinersen API manufacturers, exporters, distributors and traders.
click here to find a list of Nusinersen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nusinersen DMF (Drug Master File) is a document detailing the whole manufacturing process of Nusinersen active pharmaceutical ingredient (API) in detail. Different forms of Nusinersen DMFs exist exist since differing nations have different regulations, such as Nusinersen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nusinersen DMF submitted to regulatory agencies in the US is known as a USDMF. Nusinersen USDMF includes data on Nusinersen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nusinersen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nusinersen suppliers with USDMF on PharmaCompass.
