01 2PolyPeptide Group
02 2Blank
01 1THYMALFASIN
02 1THYMOSIN ALPHA I (BULK DRUG)
03 1THYMOSIN-A-1, DRUG SUBSTANCE
04 1THYMOSIN-ALPHA 1 DRUG SUBSTANCE
01 2Switzerland
02 2Blank
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16110
Submission : 2002-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20478
Submission : 2007-04-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40037
Submission : 2024-05-30
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10371
Submission : 1993-06-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Thymalfasin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thymalfasin, including repackagers and relabelers. The FDA regulates Thymalfasin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thymalfasin 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 Thymalfasin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Thymalfasin supplier is an individual or a company that provides Thymalfasin active pharmaceutical ingredient (API) or Thymalfasin finished formulations upon request. The Thymalfasin suppliers may include Thymalfasin API manufacturers, exporters, distributors and traders.
click here to find a list of Thymalfasin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thymalfasin DMF (Drug Master File) is a document detailing the whole manufacturing process of Thymalfasin active pharmaceutical ingredient (API) in detail. Different forms of Thymalfasin DMFs exist exist since differing nations have different regulations, such as Thymalfasin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thymalfasin DMF submitted to regulatory agencies in the US is known as a USDMF. Thymalfasin USDMF includes data on Thymalfasin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thymalfasin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thymalfasin suppliers with USDMF on PharmaCompass.
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