01 3ISO TEX DIAGNOSTICS INC
01 1PLATINUM-195M
02 1PLATINUM-195M (PT-195M)
03 1PT-195M CIS-PLATIN
01 3U.S.A
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13160
Submission : 1998-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13838
Submission : 1998-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13837
Submission : 1998-11-12
Status : Inactive
Type : II
A Platinum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Platinum, including repackagers and relabelers. The FDA regulates Platinum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Platinum 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 Platinum supplier is an individual or a company that provides Platinum active pharmaceutical ingredient (API) or Platinum finished formulations upon request. The Platinum suppliers may include Platinum API manufacturers, exporters, distributors and traders.
click here to find a list of Platinum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Platinum DMF (Drug Master File) is a document detailing the whole manufacturing process of Platinum active pharmaceutical ingredient (API) in detail. Different forms of Platinum DMFs exist exist since differing nations have different regulations, such as Platinum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Platinum DMF submitted to regulatory agencies in the US is known as a USDMF. Platinum USDMF includes data on Platinum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Platinum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Platinum suppliers with USDMF on PharmaCompass.
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