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
26
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A Anaboleen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anaboleen, including repackagers and relabelers. The FDA regulates Anaboleen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anaboleen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Anaboleen supplier is an individual or a company that provides Anaboleen active pharmaceutical ingredient (API) or Anaboleen finished formulations upon request. The Anaboleen suppliers may include Anaboleen API manufacturers, exporters, distributors and traders.
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A Anaboleen DMF (Drug Master File) is a document detailing the whole manufacturing process of Anaboleen active pharmaceutical ingredient (API) in detail. Different forms of Anaboleen DMFs exist exist since differing nations have different regulations, such as Anaboleen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anaboleen DMF submitted to regulatory agencies in the US is known as a USDMF. Anaboleen USDMF includes data on Anaboleen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anaboleen USDMF is kept confidential to protect the manufacturer’s intellectual property.
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