01 1Gedeon Richter
01 1PIPECURONIUM BROMIDE
01 1Hungary
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5511
Submission : 1984-09-07
Status : Inactive
Type : II
11
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A Pipecuronium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pipecuronium, including repackagers and relabelers. The FDA regulates Pipecuronium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pipecuronium 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 Pipecuronium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pipecuronium supplier is an individual or a company that provides Pipecuronium active pharmaceutical ingredient (API) or Pipecuronium finished formulations upon request. The Pipecuronium suppliers may include Pipecuronium API manufacturers, exporters, distributors and traders.
click here to find a list of Pipecuronium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pipecuronium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pipecuronium active pharmaceutical ingredient (API) in detail. Different forms of Pipecuronium DMFs exist exist since differing nations have different regulations, such as Pipecuronium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pipecuronium DMF submitted to regulatory agencies in the US is known as a USDMF. Pipecuronium USDMF includes data on Pipecuronium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pipecuronium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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