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