01 1AIRGAS USA LLC
02 1Union Carbide Corporation
01 1CARBON DIOXIDE
02 1CARBON DIOXIDE, XENON AND OXYGEN MIXTURE
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33651
Submission : 2019-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6724
Submission : 1986-11-25
Status : Inactive
Type : II
A Carbon Dioxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbon Dioxide, including repackagers and relabelers. The FDA regulates Carbon Dioxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbon Dioxide 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 Carbon Dioxide supplier is an individual or a company that provides Carbon Dioxide active pharmaceutical ingredient (API) or Carbon Dioxide finished formulations upon request. The Carbon Dioxide suppliers may include Carbon Dioxide API manufacturers, exporters, distributors and traders.
click here to find a list of Carbon Dioxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbon Dioxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbon Dioxide active pharmaceutical ingredient (API) in detail. Different forms of Carbon Dioxide DMFs exist exist since differing nations have different regulations, such as Carbon Dioxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbon Dioxide DMF submitted to regulatory agencies in the US is known as a USDMF. Carbon Dioxide USDMF includes data on Carbon Dioxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbon Dioxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbon Dioxide suppliers with USDMF on PharmaCompass.
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