01 2LIGHT SCIENCES ONCOLOGY INC
02 1Meiji Seika Pharma
01 1TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG PRODUCT
02 1TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG PRODUCT FORMULATION AND FILLING
03 1TAPORFIN SODIUM DRUG SUBSTANCE
01 1Japan
02 2U.S.A
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22405
Submission : 2009-01-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18775
Submission : 2005-09-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14914
Submission : 2000-06-06
Status : Inactive
Type : II
A Talaporfin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Talaporfin, including repackagers and relabelers. The FDA regulates Talaporfin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Talaporfin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Talaporfin supplier is an individual or a company that provides Talaporfin active pharmaceutical ingredient (API) or Talaporfin finished formulations upon request. The Talaporfin suppliers may include Talaporfin API manufacturers, exporters, distributors and traders.
click here to find a list of Talaporfin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Talaporfin DMF (Drug Master File) is a document detailing the whole manufacturing process of Talaporfin active pharmaceutical ingredient (API) in detail. Different forms of Talaporfin DMFs exist exist since differing nations have different regulations, such as Talaporfin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Talaporfin DMF submitted to regulatory agencies in the US is known as a USDMF. Talaporfin USDMF includes data on Talaporfin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Talaporfin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Talaporfin suppliers with USDMF on PharmaCompass.
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