01 3The Dow Chemical Company
01 1AMBERLITE IRP-69 & AMBERLITE IRP-70
02 1AMBERLITE IRP69
03 1AMBERLITE IRP70
01 3U.S.A
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12974
Submission : 1998-04-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-03
DMF Number : 12355
Submission : 1997-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5234
Submission : 1984-02-20
Status : Inactive
Type : II
A Amberlite Irp69 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amberlite Irp69, including repackagers and relabelers. The FDA regulates Amberlite Irp69 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amberlite Irp69 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 Amberlite Irp69 supplier is an individual or a company that provides Amberlite Irp69 active pharmaceutical ingredient (API) or Amberlite Irp69 finished formulations upon request. The Amberlite Irp69 suppliers may include Amberlite Irp69 API manufacturers, exporters, distributors and traders.
click here to find a list of Amberlite Irp69 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amberlite Irp69 DMF (Drug Master File) is a document detailing the whole manufacturing process of Amberlite Irp69 active pharmaceutical ingredient (API) in detail. Different forms of Amberlite Irp69 DMFs exist exist since differing nations have different regulations, such as Amberlite Irp69 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amberlite Irp69 DMF submitted to regulatory agencies in the US is known as a USDMF. Amberlite Irp69 USDMF includes data on Amberlite Irp69's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amberlite Irp69 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amberlite Irp69 suppliers with USDMF on PharmaCompass.
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