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