01 1Quimica Sintetica
02 2Sifavitor srl
01 1KETOTIFEN
02 1KETOTIFEN FUMERATE
03 1KETOTIFEN HYDROGEN FUMARATE
01 2Italy
02 1Spain
01 1Active
02 2Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9440
Submission : 1991-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-22
Pay. Date : 2015-02-13
DMF Number : 16201
Submission : 2002-10-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21687
Submission : 2008-06-11
Status : Inactive
Type : II
A Ketotifen Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketotifen Fumarate, including repackagers and relabelers. The FDA regulates Ketotifen Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketotifen Fumarate 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 Ketotifen Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketotifen Fumarate supplier is an individual or a company that provides Ketotifen Fumarate active pharmaceutical ingredient (API) or Ketotifen Fumarate finished formulations upon request. The Ketotifen Fumarate suppliers may include Ketotifen Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Ketotifen Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketotifen Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketotifen Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Ketotifen Fumarate DMFs exist exist since differing nations have different regulations, such as Ketotifen Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketotifen Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Ketotifen Fumarate USDMF includes data on Ketotifen Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketotifen Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketotifen Fumarate suppliers with USDMF on PharmaCompass.
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