01 1Siegfried AG
01 1(-)-EPHEDRINE SALTS
01 1Switzerland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4358
Submission : 1981-10-20
Status : Active
Type : II
A Ephedrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ephedrine, including repackagers and relabelers. The FDA regulates Ephedrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ephedrine 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 Ephedrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ephedrine supplier is an individual or a company that provides Ephedrine active pharmaceutical ingredient (API) or Ephedrine finished formulations upon request. The Ephedrine suppliers may include Ephedrine API manufacturers, exporters, distributors and traders.
click here to find a list of Ephedrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ephedrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ephedrine active pharmaceutical ingredient (API) in detail. Different forms of Ephedrine DMFs exist exist since differing nations have different regulations, such as Ephedrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ephedrine DMF submitted to regulatory agencies in the US is known as a USDMF. Ephedrine USDMF includes data on Ephedrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ephedrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ephedrine suppliers with USDMF on PharmaCompass.
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