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01 1CIBENZOLINE SUCCINATE INN. OR CIFENLINE SUCCINATE USAN
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7338
Submission : 1988-02-19
Status : Inactive
Type : II
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A Cifenline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cifenline, including repackagers and relabelers. The FDA regulates Cifenline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cifenline 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 Cifenline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cifenline supplier is an individual or a company that provides Cifenline active pharmaceutical ingredient (API) or Cifenline finished formulations upon request. The Cifenline suppliers may include Cifenline API manufacturers, exporters, distributors and traders.
click here to find a list of Cifenline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cifenline DMF (Drug Master File) is a document detailing the whole manufacturing process of Cifenline active pharmaceutical ingredient (API) in detail. Different forms of Cifenline DMFs exist exist since differing nations have different regulations, such as Cifenline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cifenline DMF submitted to regulatory agencies in the US is known as a USDMF. Cifenline USDMF includes data on Cifenline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cifenline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cifenline suppliers with USDMF on PharmaCompass.
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