01 1Zhejiang Medicine Co Ltd
01 1MIGLITOL
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-23
DMF Number : 18833
Submission : 2005-01-22
Status : Active
Type : II
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A Diaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diaban, including repackagers and relabelers. The FDA regulates Diaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diaban 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 Diaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Diaban supplier is an individual or a company that provides Diaban active pharmaceutical ingredient (API) or Diaban finished formulations upon request. The Diaban suppliers may include Diaban API manufacturers, exporters, distributors and traders.
click here to find a list of Diaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Diaban DMF (Drug Master File) is a document detailing the whole manufacturing process of Diaban active pharmaceutical ingredient (API) in detail. Different forms of Diaban DMFs exist exist since differing nations have different regulations, such as Diaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diaban DMF submitted to regulatory agencies in the US is known as a USDMF. Diaban USDMF includes data on Diaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diaban USDMF is kept confidential to protect the manufacturer’s intellectual property.
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