01 2SAFC
01 1TRYPAN BLUE
02 1TRYPAN BLUE PURIFIED
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28998
Submission : 2015-01-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17764
Submission : 2004-10-15
Status : Inactive
Type : II
A Trypan Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trypan Blue, including repackagers and relabelers. The FDA regulates Trypan Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trypan Blue 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 Trypan Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trypan Blue supplier is an individual or a company that provides Trypan Blue active pharmaceutical ingredient (API) or Trypan Blue finished formulations upon request. The Trypan Blue suppliers may include Trypan Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Trypan Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trypan Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Trypan Blue active pharmaceutical ingredient (API) in detail. Different forms of Trypan Blue DMFs exist exist since differing nations have different regulations, such as Trypan Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trypan Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Trypan Blue USDMF includes data on Trypan Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trypan Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trypan Blue suppliers with USDMF on PharmaCompass.
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