01 1Mitsui & Co.,Ltd
01 1POLYPHENON E (NON TOPICAL USE)
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22693
Submission : 2009-03-31
Status : Active
Type : II
A Cianidanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cianidanol, including repackagers and relabelers. The FDA regulates Cianidanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cianidanol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cianidanol supplier is an individual or a company that provides Cianidanol active pharmaceutical ingredient (API) or Cianidanol finished formulations upon request. The Cianidanol suppliers may include Cianidanol API manufacturers, exporters, distributors and traders.
click here to find a list of Cianidanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cianidanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Cianidanol active pharmaceutical ingredient (API) in detail. Different forms of Cianidanol DMFs exist exist since differing nations have different regulations, such as Cianidanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cianidanol DMF submitted to regulatory agencies in the US is known as a USDMF. Cianidanol USDMF includes data on Cianidanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cianidanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cianidanol suppliers with USDMF on PharmaCompass.
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