01 1Siegfried AG
01 1AMOROLFINE HYDROCHLORIDE
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16254
Submission : 2002-11-19
Status : Inactive
Type : II
A Locetar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Locetar, including repackagers and relabelers. The FDA regulates Locetar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Locetar 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 Locetar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Locetar supplier is an individual or a company that provides Locetar active pharmaceutical ingredient (API) or Locetar finished formulations upon request. The Locetar suppliers may include Locetar API manufacturers, exporters, distributors and traders.
click here to find a list of Locetar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Locetar DMF (Drug Master File) is a document detailing the whole manufacturing process of Locetar active pharmaceutical ingredient (API) in detail. Different forms of Locetar DMFs exist exist since differing nations have different regulations, such as Locetar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Locetar DMF submitted to regulatory agencies in the US is known as a USDMF. Locetar USDMF includes data on Locetar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Locetar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Locetar suppliers with USDMF on PharmaCompass.
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