01 1Standard Chem. & Pharm. Co., Ltd
01 1THEOPHYLLINE SODIUM GLYCINATE
01 1Taiwan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18896
Submission : 2005-10-17
Status : Inactive
Type : II
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A Theo-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theo-Dur, including repackagers and relabelers. The FDA regulates Theo-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theo-Dur 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 Theo-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Theo-Dur supplier is an individual or a company that provides Theo-Dur active pharmaceutical ingredient (API) or Theo-Dur finished formulations upon request. The Theo-Dur suppliers may include Theo-Dur API manufacturers, exporters, distributors and traders.
click here to find a list of Theo-Dur suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Theo-Dur DMF (Drug Master File) is a document detailing the whole manufacturing process of Theo-Dur active pharmaceutical ingredient (API) in detail. Different forms of Theo-Dur DMFs exist exist since differing nations have different regulations, such as Theo-Dur USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Theo-Dur DMF submitted to regulatory agencies in the US is known as a USDMF. Theo-Dur USDMF includes data on Theo-Dur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Theo-Dur USDMF is kept confidential to protect the manufacturer’s intellectual property.
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