01 1Recordati
02 2Blank
01 1GALLOPAMIL HCL
02 1GALLOPAMIL HCl
03 1PROCORUM (GALLOPAMIL HCL,50MG)TABS
01 1Italy
02 2Blank
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8151
Submission : 1989-07-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5619
Submission : 1984-11-19
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 : 5526
Submission : 1984-09-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Gallopamil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gallopamil, including repackagers and relabelers. The FDA regulates Gallopamil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gallopamil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Gallopamil supplier is an individual or a company that provides Gallopamil active pharmaceutical ingredient (API) or Gallopamil finished formulations upon request. The Gallopamil suppliers may include Gallopamil API manufacturers, exporters, distributors and traders.
click here to find a list of Gallopamil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gallopamil DMF (Drug Master File) is a document detailing the whole manufacturing process of Gallopamil active pharmaceutical ingredient (API) in detail. Different forms of Gallopamil DMFs exist exist since differing nations have different regulations, such as Gallopamil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gallopamil DMF submitted to regulatory agencies in the US is known as a USDMF. Gallopamil USDMF includes data on Gallopamil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gallopamil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gallopamil suppliers with USDMF on PharmaCompass.
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