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
98
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A (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine, including repackagers and relabelers. The FDA regulates (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine supplier is an individual or a company that provides (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine active pharmaceutical ingredient (API) or (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine finished formulations upon request. The (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine suppliers may include (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine API manufacturers, exporters, distributors and traders.
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A (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine DMF (Drug Master File) is a document detailing the whole manufacturing process of (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine active pharmaceutical ingredient (API) in detail. Different forms of (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine DMFs exist exist since differing nations have different regulations, such as (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine DMF submitted to regulatory agencies in the US is known as a USDMF. (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine USDMF includes data on (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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