01 1Mallinckrodt Pharmaceuticals
01 1ZICONOTIDE (SNX-111), CODE 8068
01 1Ireland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10123
Submission : 1993-03-09
Status : Inactive
Type : II
A Ziconotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ziconotide, including repackagers and relabelers. The FDA regulates Ziconotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ziconotide 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 Ziconotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ziconotide supplier is an individual or a company that provides Ziconotide active pharmaceutical ingredient (API) or Ziconotide finished formulations upon request. The Ziconotide suppliers may include Ziconotide API manufacturers, exporters, distributors and traders.
click here to find a list of Ziconotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ziconotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Ziconotide active pharmaceutical ingredient (API) in detail. Different forms of Ziconotide DMFs exist exist since differing nations have different regulations, such as Ziconotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ziconotide DMF submitted to regulatory agencies in the US is known as a USDMF. Ziconotide USDMF includes data on Ziconotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ziconotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ziconotide suppliers with USDMF on PharmaCompass.
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