01 1ABRAXIS BIOSCIENCE
02 1AIR PRODUCTS FR 38070 Saint Quentin Fallavier
03 1Air Liquide Healthcare America Corp.
04 1FLUOROMED LP
05 1Mallinckrodt Pharmaceuticals
06 2Blank
01 1APF-N30 (PERFLUOROPROPANE)
02 1APF-N40M
03 1IDN 5404 ALBUMIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-011)
04 1OPTISON
05 1PERFLUOROPROPANE (OCTAFLUOROPROPANE) GAS
06 1PERFLUOROPROPANE (OCTOFLUROPROPANE) GAS
07 1PERFLUOROPROPANE(OCTAFLUOROPROPANE)GAS
01 1France
02 1Ireland
03 3U.S.A
04 2Blank
01 2Active
02 5Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28533
Submission : 2015-06-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16400
Submission : 2003-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11695
Submission : 1995-09-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12637
Submission : 1997-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12913
Submission : 1998-03-10
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14405
Submission : 1999-09-14
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12777
Submission : 1997-12-08
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Perflutren manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perflutren, including repackagers and relabelers. The FDA regulates Perflutren manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perflutren API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Perflutren manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perflutren supplier is an individual or a company that provides Perflutren active pharmaceutical ingredient (API) or Perflutren finished formulations upon request. The Perflutren suppliers may include Perflutren API manufacturers, exporters, distributors and traders.
click here to find a list of Perflutren suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perflutren DMF (Drug Master File) is a document detailing the whole manufacturing process of Perflutren active pharmaceutical ingredient (API) in detail. Different forms of Perflutren DMFs exist exist since differing nations have different regulations, such as Perflutren USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perflutren DMF submitted to regulatory agencies in the US is known as a USDMF. Perflutren USDMF includes data on Perflutren's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perflutren USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perflutren suppliers with USDMF on PharmaCompass.
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