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