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