01 1Zambon Switzerland
01 1THIAMPHENICOL
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6192
Submission : 1986-01-17
Status : Inactive
Type : II
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A Urfamycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urfamycin, including repackagers and relabelers. The FDA regulates Urfamycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urfamycin 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 Urfamycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Urfamycin supplier is an individual or a company that provides Urfamycin active pharmaceutical ingredient (API) or Urfamycin finished formulations upon request. The Urfamycin suppliers may include Urfamycin API manufacturers, exporters, distributors and traders.
click here to find a list of Urfamycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Urfamycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Urfamycin active pharmaceutical ingredient (API) in detail. Different forms of Urfamycin DMFs exist exist since differing nations have different regulations, such as Urfamycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urfamycin DMF submitted to regulatory agencies in the US is known as a USDMF. Urfamycin USDMF includes data on Urfamycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urfamycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urfamycin suppliers with USDMF on PharmaCompass.
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