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