01 1Syn-Tech Chem. & Pharm
01 1NAFTOPIDIL
01 1Taiwan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26502
Submission : 2012-09-26
Status : Active
Type : II
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A Flivas manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flivas, including repackagers and relabelers. The FDA regulates Flivas manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flivas 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 Flivas manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Flivas supplier is an individual or a company that provides Flivas active pharmaceutical ingredient (API) or Flivas finished formulations upon request. The Flivas suppliers may include Flivas API manufacturers, exporters, distributors and traders.
click here to find a list of Flivas suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Flivas DMF (Drug Master File) is a document detailing the whole manufacturing process of Flivas active pharmaceutical ingredient (API) in detail. Different forms of Flivas DMFs exist exist since differing nations have different regulations, such as Flivas USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flivas DMF submitted to regulatory agencies in the US is known as a USDMF. Flivas USDMF includes data on Flivas's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flivas USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flivas suppliers with USDMF on PharmaCompass.
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