Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

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