01 1Daiichi Sankyo
02 1UBE Industries
01 1CS-615 DRUG PRODUCT
02 1CS-615 DRUG SUBSTANCE
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13280
Submission : 1998-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13273
Submission : 1998-10-14
Status : Inactive
Type : II
A Troglitazone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Troglitazone, including repackagers and relabelers. The FDA regulates Troglitazone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Troglitazone 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 Troglitazone supplier is an individual or a company that provides Troglitazone active pharmaceutical ingredient (API) or Troglitazone finished formulations upon request. The Troglitazone suppliers may include Troglitazone API manufacturers, exporters, distributors and traders.
click here to find a list of Troglitazone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Troglitazone DMF (Drug Master File) is a document detailing the whole manufacturing process of Troglitazone active pharmaceutical ingredient (API) in detail. Different forms of Troglitazone DMFs exist exist since differing nations have different regulations, such as Troglitazone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Troglitazone DMF submitted to regulatory agencies in the US is known as a USDMF. Troglitazone USDMF includes data on Troglitazone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Troglitazone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Troglitazone suppliers with USDMF on PharmaCompass.
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