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