01 1Yonezawa Hamari Chemicals\
01 1POLAPREZINC
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21259
Submission : 2008-01-14
Status : Inactive
Type : II
A Polaprezinc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polaprezinc, including repackagers and relabelers. The FDA regulates Polaprezinc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polaprezinc 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 Polaprezinc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polaprezinc supplier is an individual or a company that provides Polaprezinc active pharmaceutical ingredient (API) or Polaprezinc finished formulations upon request. The Polaprezinc suppliers may include Polaprezinc API manufacturers, exporters, distributors and traders.
click here to find a list of Polaprezinc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polaprezinc DMF (Drug Master File) is a document detailing the whole manufacturing process of Polaprezinc active pharmaceutical ingredient (API) in detail. Different forms of Polaprezinc DMFs exist exist since differing nations have different regulations, such as Polaprezinc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polaprezinc DMF submitted to regulatory agencies in the US is known as a USDMF. Polaprezinc USDMF includes data on Polaprezinc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polaprezinc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polaprezinc suppliers with USDMF on PharmaCompass.
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