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
33
PharmaCompass offers a list of Ketotifen Fumarate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ketotifen Fumarate manufacturer or Ketotifen Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ketotifen Fumarate manufacturer or Ketotifen Fumarate supplier.
PharmaCompass also assists you with knowing the Ketotifen Fumarate API Price utilized in the formulation of products. Ketotifen Fumarate API Price is not always fixed or binding as the Ketotifen Fumarate Price is obtained through a variety of data sources. The Ketotifen Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zaditen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zaditen, including repackagers and relabelers. The FDA regulates Zaditen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zaditen 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 Zaditen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zaditen supplier is an individual or a company that provides Zaditen active pharmaceutical ingredient (API) or Zaditen finished formulations upon request. The Zaditen suppliers may include Zaditen API manufacturers, exporters, distributors and traders.
click here to find a list of Zaditen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zaditen DMF (Drug Master File) is a document detailing the whole manufacturing process of Zaditen active pharmaceutical ingredient (API) in detail. Different forms of Zaditen DMFs exist exist since differing nations have different regulations, such as Zaditen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zaditen DMF submitted to regulatory agencies in the US is known as a USDMF. Zaditen USDMF includes data on Zaditen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zaditen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zaditen suppliers with USDMF on PharmaCompass.
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