ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Abbott Laboratories
03 1Archimica
04 1Chongqing Pharmaceutical Research Institute Co Ltd
01 2AMRINONE
02 1AMRINONE, USP
03 1INAMRINONE USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE
01 1China
02 1Italy
03 2U.S.A
01 1Active
02 3Inactive
01 4Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13087
Submission : 1998-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11085
Submission : 1994-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13193
Submission : 1998-09-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9491
Submission : 1991-12-31
Status : Inactive
Type : II
A inamrinone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of inamrinone, including repackagers and relabelers. The FDA regulates inamrinone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. inamrinone 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 inamrinone supplier is an individual or a company that provides inamrinone active pharmaceutical ingredient (API) or inamrinone finished formulations upon request. The inamrinone suppliers may include inamrinone API manufacturers, exporters, distributors and traders.
click here to find a list of inamrinone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A inamrinone DMF (Drug Master File) is a document detailing the whole manufacturing process of inamrinone active pharmaceutical ingredient (API) in detail. Different forms of inamrinone DMFs exist exist since differing nations have different regulations, such as inamrinone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A inamrinone DMF submitted to regulatory agencies in the US is known as a USDMF. inamrinone USDMF includes data on inamrinone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The inamrinone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of inamrinone suppliers with USDMF on PharmaCompass.
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