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