01 1Apicore LLC
02 1CordenPharma
03 1Industriale Chimica
04 1Jiangsu Lianhuan Pharmaceutical
05 1Reliable Biopharmaceutical Corporation
06 1Viatris
01 1PHENTOLAMINE MESILATE USP
02 2PHENTOLAMINE MESYLATE
03 1PHENTOLAMINE MESYLATE USP
04 2PHENTOLAMINE MESYLATE, USP
01 1China
02 1Germany
03 1India
04 1Italy
05 2U.S.A
01 5Active
02 1Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39948
Submission : 2024-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11936
Submission : 1996-04-19
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-10
Pay. Date : 2012-12-21
DMF Number : 16428
Submission : 2003-02-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39578
Submission : 2024-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12260
Submission : 1996-12-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2014-06-12
DMF Number : 28193
Submission : 2014-06-16
Status : Active
Type : II
A Phentolamine Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phentolamine Mesylate, including repackagers and relabelers. The FDA regulates Phentolamine Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phentolamine Mesylate 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 Phentolamine Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phentolamine Mesylate supplier is an individual or a company that provides Phentolamine Mesylate active pharmaceutical ingredient (API) or Phentolamine Mesylate finished formulations upon request. The Phentolamine Mesylate suppliers may include Phentolamine Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Phentolamine Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phentolamine Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Phentolamine Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Phentolamine Mesylate DMFs exist exist since differing nations have different regulations, such as Phentolamine Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phentolamine Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Phentolamine Mesylate USDMF includes data on Phentolamine Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phentolamine Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phentolamine Mesylate suppliers with USDMF on PharmaCompass.
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