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