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01 1Kissei Pharmaceutical
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01 1LINZAGOLIX CHOLINE
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01 1Japan
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01 1Active
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35700
Submission : 2021-06-03
Status : Active
Type : II
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PharmaCompass offers a list of Linzagolix 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 Linzagolix manufacturer or Linzagolix supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Linzagolix manufacturer or Linzagolix supplier.
PharmaCompass also assists you with knowing the Linzagolix API Price utilized in the formulation of products. Linzagolix API Price is not always fixed or binding as the Linzagolix Price is obtained through a variety of data sources. The Linzagolix Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Linzagolix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linzagolix, including repackagers and relabelers. The FDA regulates Linzagolix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linzagolix 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 Linzagolix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linzagolix supplier is an individual or a company that provides Linzagolix active pharmaceutical ingredient (API) or Linzagolix finished formulations upon request. The Linzagolix suppliers may include Linzagolix API manufacturers, exporters, distributors and traders.
click here to find a list of Linzagolix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Linzagolix DMF (Drug Master File) is a document detailing the whole manufacturing process of Linzagolix active pharmaceutical ingredient (API) in detail. Different forms of Linzagolix DMFs exist exist since differing nations have different regulations, such as Linzagolix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Linzagolix DMF submitted to regulatory agencies in the US is known as a USDMF. Linzagolix USDMF includes data on Linzagolix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Linzagolix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Linzagolix suppliers with USDMF on PharmaCompass.
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