01 1ABC Farmaceutici SpA
01 1NALIDIXIC ACID
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6570
Submission : 1986-08-28
Status : Inactive
Type : II
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A Uriclar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uriclar, including repackagers and relabelers. The FDA regulates Uriclar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uriclar 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 Uriclar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Uriclar supplier is an individual or a company that provides Uriclar active pharmaceutical ingredient (API) or Uriclar finished formulations upon request. The Uriclar suppliers may include Uriclar API manufacturers, exporters, distributors and traders.
click here to find a list of Uriclar suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Uriclar DMF (Drug Master File) is a document detailing the whole manufacturing process of Uriclar active pharmaceutical ingredient (API) in detail. Different forms of Uriclar DMFs exist exist since differing nations have different regulations, such as Uriclar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uriclar DMF submitted to regulatory agencies in the US is known as a USDMF. Uriclar USDMF includes data on Uriclar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uriclar USDMF is kept confidential to protect the manufacturer’s intellectual property.
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