01 1Cyalume Specialty Products
01 1DICHLORALPHENAZONE USP
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23691
Submission : 2010-04-06
Status : Active
Type : II
A Dichloralantipyrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dichloralantipyrine, including repackagers and relabelers. The FDA regulates Dichloralantipyrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dichloralantipyrine 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 Dichloralantipyrine supplier is an individual or a company that provides Dichloralantipyrine active pharmaceutical ingredient (API) or Dichloralantipyrine finished formulations upon request. The Dichloralantipyrine suppliers may include Dichloralantipyrine API manufacturers, exporters, distributors and traders.
click here to find a list of Dichloralantipyrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dichloralantipyrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dichloralantipyrine active pharmaceutical ingredient (API) in detail. Different forms of Dichloralantipyrine DMFs exist exist since differing nations have different regulations, such as Dichloralantipyrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dichloralantipyrine DMF submitted to regulatory agencies in the US is known as a USDMF. Dichloralantipyrine USDMF includes data on Dichloralantipyrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dichloralantipyrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dichloralantipyrine suppliers with USDMF on PharmaCompass.
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