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