01 1Laboratorio Syntex S.A
01 1GUANADREL (CL-1388-R)
01 1Argentina
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1357
Submission : 1969-04-28
Status : Inactive
Type : II
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PharmaCompass offers a list of Guanadrel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Guanadrel manufacturer or Guanadrel supplier for your needs.
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A Guanadrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guanadrel, including repackagers and relabelers. The FDA regulates Guanadrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guanadrel API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Guanadrel supplier is an individual or a company that provides Guanadrel active pharmaceutical ingredient (API) or Guanadrel finished formulations upon request. The Guanadrel suppliers may include Guanadrel API manufacturers, exporters, distributors and traders.
click here to find a list of Guanadrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Guanadrel DMF (Drug Master File) is a document detailing the whole manufacturing process of Guanadrel active pharmaceutical ingredient (API) in detail. Different forms of Guanadrel DMFs exist exist since differing nations have different regulations, such as Guanadrel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Guanadrel DMF submitted to regulatory agencies in the US is known as a USDMF. Guanadrel USDMF includes data on Guanadrel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Guanadrel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Guanadrel suppliers with USDMF on PharmaCompass.
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