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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PharmaCompass offers a list of Miglitol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Miglitol manufacturer or Miglitol supplier for your needs.
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A Miglitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miglitol, including repackagers and relabelers. The FDA regulates Miglitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miglitol 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 Miglitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Miglitol supplier is an individual or a company that provides Miglitol active pharmaceutical ingredient (API) or Miglitol finished formulations upon request. The Miglitol suppliers may include Miglitol API manufacturers, exporters, distributors and traders.
click here to find a list of Miglitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Miglitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Miglitol active pharmaceutical ingredient (API) in detail. Different forms of Miglitol DMFs exist exist since differing nations have different regulations, such as Miglitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Miglitol DMF submitted to regulatory agencies in the US is known as a USDMF. Miglitol USDMF includes data on Miglitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Miglitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Miglitol suppliers with USDMF on PharmaCompass.
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