01 1Meiji Seika Pharma
01 1PIRARUBICIN HCl FOR INJECTION
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8197
Submission : 1989-09-05
Status : Inactive
Type : II
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A Pirarubicin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirarubicin HCl, including repackagers and relabelers. The FDA regulates Pirarubicin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirarubicin HCl 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 Pirarubicin HCl supplier is an individual or a company that provides Pirarubicin HCl active pharmaceutical ingredient (API) or Pirarubicin HCl finished formulations upon request. The Pirarubicin HCl suppliers may include Pirarubicin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Pirarubicin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pirarubicin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Pirarubicin HCl active pharmaceutical ingredient (API) in detail. Different forms of Pirarubicin HCl DMFs exist exist since differing nations have different regulations, such as Pirarubicin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pirarubicin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Pirarubicin HCl USDMF includes data on Pirarubicin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pirarubicin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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