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01 4St. Gobain Performance Plastics
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01 1TYGON (R)R 3350 - SANITARY SILICONE TUBING
02 1TYGON S-50-HL MEDICAL/SURGICAL TUBING
03 1TYGON(R) S-50-HL MEDICAL/SURGICAL TUBING
04 1TYGONr 2475 HIGH PURITY TUBING AND TYGONr 2475 I.B. HIGH PURITY PRESSURE TUBING
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01 4France
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01 4Inactive
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01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20743
Submission : 2007-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19844
Submission : 2006-10-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19475
Submission : 2006-05-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25831
Submission : 2012-02-24
Status : Inactive
Type : II
A Pevikon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pevikon, including repackagers and relabelers. The FDA regulates Pevikon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pevikon 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 Pevikon supplier is an individual or a company that provides Pevikon active pharmaceutical ingredient (API) or Pevikon finished formulations upon request. The Pevikon suppliers may include Pevikon API manufacturers, exporters, distributors and traders.
click here to find a list of Pevikon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pevikon DMF (Drug Master File) is a document detailing the whole manufacturing process of Pevikon active pharmaceutical ingredient (API) in detail. Different forms of Pevikon DMFs exist exist since differing nations have different regulations, such as Pevikon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pevikon DMF submitted to regulatory agencies in the US is known as a USDMF. Pevikon USDMF includes data on Pevikon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pevikon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pevikon suppliers with USDMF on PharmaCompass.
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