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01 2Axplora
02 2TAPI Technology & API Services
03 2SIMS Srl
04 1Blank
01 2FLUNISOLIDE
02 1FLUNISOLIDE ANHYDROUS
03 1FLUNISOLIDE ANHYDROUS (NEW PROCESS)
04 1FLUNISOLIDE ANHYDROUS USP
05 1FLUNISOLIDE HEMIHYDRATE
06 1FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
01 2Germany
02 2Israel
03 2Italy
04 1Blank
01 4Active
02 3Inactive
01 4Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 19477
Submission : 2006-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2013-04-10
DMF Number : 11574
Submission : 1995-07-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2014-05-27
DMF Number : 26148
Submission : 2012-06-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2012-11-08
DMF Number : 22772
Submission : 2009-05-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6811
Submission : 1987-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4774
Submission : 1982-12-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8459
Submission : 1990-02-27
Status : Inactive
Type : II
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A Flunisolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flunisolide, including repackagers and relabelers. The FDA regulates Flunisolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flunisolide 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 Flunisolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flunisolide supplier is an individual or a company that provides Flunisolide active pharmaceutical ingredient (API) or Flunisolide finished formulations upon request. The Flunisolide suppliers may include Flunisolide API manufacturers, exporters, distributors and traders.
click here to find a list of Flunisolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flunisolide DMF (Drug Master File) is a document detailing the whole manufacturing process of Flunisolide active pharmaceutical ingredient (API) in detail. Different forms of Flunisolide DMFs exist exist since differing nations have different regulations, such as Flunisolide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flunisolide DMF submitted to regulatory agencies in the US is known as a USDMF. Flunisolide USDMF includes data on Flunisolide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flunisolide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flunisolide suppliers with USDMF on PharmaCompass.
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