01 1Kissei Pharmaceutical
01 1LINZAGOLIX CHOLINE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35700
Submission : 2021-06-03
Status : Active
Type : II
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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