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