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