01 1COSMA S.p.A
02 1Daiichi Sankyo
03 1SIGMA TAU
04 1Blank
01 1D-PANTETHINE
02 2PANTETHINE
03 1PANTETHINE BULK SUBSTANCE
01 1Italy
02 1Japan
03 1U.S.A
04 1Blank
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10069
Submission : 1993-02-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8887
Submission : 1990-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5101
Submission : 1983-07-18
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9358
Submission : 1991-09-26
Status : Inactive
Type : II
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Corporate PDF
A Pantethine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pantethine, including repackagers and relabelers. The FDA regulates Pantethine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pantethine 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 Pantethine supplier is an individual or a company that provides Pantethine active pharmaceutical ingredient (API) or Pantethine finished formulations upon request. The Pantethine suppliers may include Pantethine API manufacturers, exporters, distributors and traders.
click here to find a list of Pantethine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pantethine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pantethine active pharmaceutical ingredient (API) in detail. Different forms of Pantethine DMFs exist exist since differing nations have different regulations, such as Pantethine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pantethine DMF submitted to regulatory agencies in the US is known as a USDMF. Pantethine USDMF includes data on Pantethine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pantethine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pantethine suppliers with USDMF on PharmaCompass.
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