01 1Air Liquide Healthcare America Corp.
02 1FLUOROMED LP
03 1GE Healthcare Inc
01 199M TC-PERTECHNETATE-SULFUR COLLOID
02 1SULFUR HEXAFLUORIDE (SF6) GAS
03 1SULFUR HEXAFLUORIDE, 99.8%
01 2U.S.A
02 1United Kingdom
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15094
Submission : 2000-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37317
Submission : 2023-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1888
Submission : 1972-03-08
Status : Inactive
Type : II
A Lumason manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumason, including repackagers and relabelers. The FDA regulates Lumason manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumason 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 Lumason supplier is an individual or a company that provides Lumason active pharmaceutical ingredient (API) or Lumason finished formulations upon request. The Lumason suppliers may include Lumason API manufacturers, exporters, distributors and traders.
click here to find a list of Lumason suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lumason DMF (Drug Master File) is a document detailing the whole manufacturing process of Lumason active pharmaceutical ingredient (API) in detail. Different forms of Lumason DMFs exist exist since differing nations have different regulations, such as Lumason USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lumason DMF submitted to regulatory agencies in the US is known as a USDMF. Lumason USDMF includes data on Lumason's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lumason USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lumason suppliers with USDMF on PharmaCompass.
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