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