01 1Kreative Organics
01 1CHOLINE MAGNESIUM TRISALICYLATE POWDER
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24027
Submission : 2010-08-05
Status : Active
Type : II
A Trisalicylate-Choline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trisalicylate-Choline, including repackagers and relabelers. The FDA regulates Trisalicylate-Choline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trisalicylate-Choline API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Trisalicylate-Choline supplier is an individual or a company that provides Trisalicylate-Choline active pharmaceutical ingredient (API) or Trisalicylate-Choline finished formulations upon request. The Trisalicylate-Choline suppliers may include Trisalicylate-Choline API manufacturers, exporters, distributors and traders.
click here to find a list of Trisalicylate-Choline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trisalicylate-Choline DMF (Drug Master File) is a document detailing the whole manufacturing process of Trisalicylate-Choline active pharmaceutical ingredient (API) in detail. Different forms of Trisalicylate-Choline DMFs exist exist since differing nations have different regulations, such as Trisalicylate-Choline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trisalicylate-Choline DMF submitted to regulatory agencies in the US is known as a USDMF. Trisalicylate-Choline USDMF includes data on Trisalicylate-Choline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trisalicylate-Choline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trisalicylate-Choline suppliers with USDMF on PharmaCompass.
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