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