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