01 1F.I.S. Fabbrica Italiana Sintetici
02 1Novartis Pharmaceuticals Corporation
03 1Olon S.p.A
01 2TERBINAFINE
02 1TERBINAFINE HCL
01 2Italy
02 1Switzerland
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20266
Submission : 2007-01-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27059
Submission : 2013-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33058
Submission : 2019-06-18
Status : Active
Type : II
A Terbinafine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terbinafine, including repackagers and relabelers. The FDA regulates Terbinafine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terbinafine 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 Terbinafine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terbinafine supplier is an individual or a company that provides Terbinafine active pharmaceutical ingredient (API) or Terbinafine finished formulations upon request. The Terbinafine suppliers may include Terbinafine API manufacturers, exporters, distributors and traders.
click here to find a list of Terbinafine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terbinafine DMF (Drug Master File) is a document detailing the whole manufacturing process of Terbinafine active pharmaceutical ingredient (API) in detail. Different forms of Terbinafine DMFs exist exist since differing nations have different regulations, such as Terbinafine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terbinafine DMF submitted to regulatory agencies in the US is known as a USDMF. Terbinafine USDMF includes data on Terbinafine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terbinafine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terbinafine suppliers with USDMF on PharmaCompass.
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