01 1Fujifilm Diosynth Biotechnologies
02 1Merck & Co
03 1SIGMA TAU
01 1ANDROSTANOLONE
02 1STANOLONE
03 1STERILE PROCESSING DETAILS OF PHASE - 18
01 2U.S.A
02 1United Kingdom
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8954
Submission : 1991-01-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16907
Submission : 2003-10-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2596
Submission : 1976-01-16
Status : Inactive
Type : II
A Proteina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proteina, including repackagers and relabelers. The FDA regulates Proteina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proteina 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 Proteina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Proteina supplier is an individual or a company that provides Proteina active pharmaceutical ingredient (API) or Proteina finished formulations upon request. The Proteina suppliers may include Proteina API manufacturers, exporters, distributors and traders.
click here to find a list of Proteina suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Proteina DMF (Drug Master File) is a document detailing the whole manufacturing process of Proteina active pharmaceutical ingredient (API) in detail. Different forms of Proteina DMFs exist exist since differing nations have different regulations, such as Proteina USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Proteina DMF submitted to regulatory agencies in the US is known as a USDMF. Proteina USDMF includes data on Proteina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Proteina USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Proteina suppliers with USDMF on PharmaCompass.
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