01 1Corden Pharma Bergamo S.p.A
02 1H. Lundbeck AS
03 1Lupin Ltd
04 1Pisgah Labs
05 2R L Fine Chem
06 3Blank
01 7IMIPRAMINE PAMOATE
02 1IMIPRAMINE PAMOATE DRUG SUBSTANCE
03 1IMIPRAMINE PAMOATE USP
01 1Denmark
02 3India
03 1Italy
04 1U.S.A
05 3Blank
01 3Active
02 6Inactive
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23076
Submission : 2009-08-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22104
Submission : 2008-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21493
Submission : 2008-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15359
Submission : 2001-03-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19612
Submission : 2006-07-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18801
Submission : 2005-09-02
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14150
Submission : 1999-05-21
Status : Inactive
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 : 6763
Submission : 1986-12-23
Status : Inactive
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 : 5322
Submission : 1984-04-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Prazepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prazepine, including repackagers and relabelers. The FDA regulates Prazepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prazepine 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 Prazepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prazepine supplier is an individual or a company that provides Prazepine active pharmaceutical ingredient (API) or Prazepine finished formulations upon request. The Prazepine suppliers may include Prazepine API manufacturers, exporters, distributors and traders.
click here to find a list of Prazepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prazepine DMF (Drug Master File) is a document detailing the whole manufacturing process of Prazepine active pharmaceutical ingredient (API) in detail. Different forms of Prazepine DMFs exist exist since differing nations have different regulations, such as Prazepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prazepine DMF submitted to regulatory agencies in the US is known as a USDMF. Prazepine USDMF includes data on Prazepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prazepine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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