01 2PolyPeptide Group
02 2Blank
01 3TERLIPRESSIN ACETATE
02 1TERLIPRESSIN DRUG SUBSTANCE
01 2Switzerland
02 2Blank
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34391
Submission : 2019-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25589
Submission : 2011-12-21
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39987
Submission : 2024-05-29
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 : 9995
Submission : 1992-12-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Terlipressin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terlipressin, including repackagers and relabelers. The FDA regulates Terlipressin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terlipressin 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 Terlipressin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terlipressin supplier is an individual or a company that provides Terlipressin active pharmaceutical ingredient (API) or Terlipressin finished formulations upon request. The Terlipressin suppliers may include Terlipressin API manufacturers, exporters, distributors and traders.
click here to find a list of Terlipressin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terlipressin DMF (Drug Master File) is a document detailing the whole manufacturing process of Terlipressin active pharmaceutical ingredient (API) in detail. Different forms of Terlipressin DMFs exist exist since differing nations have different regulations, such as Terlipressin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terlipressin DMF submitted to regulatory agencies in the US is known as a USDMF. Terlipressin USDMF includes data on Terlipressin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terlipressin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terlipressin suppliers with USDMF on PharmaCompass.
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