01 1CHIMEX
01 1MEXORYL SX (ECAMSULE)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15517
Submission : 2001-06-28
Status : Active
Type : II
A Terephthalylidene Dicamphor Sulfonic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terephthalylidene Dicamphor Sulfonic Acid, including repackagers and relabelers. The FDA regulates Terephthalylidene Dicamphor Sulfonic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terephthalylidene Dicamphor Sulfonic Acid 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 Terephthalylidene Dicamphor Sulfonic Acid supplier is an individual or a company that provides Terephthalylidene Dicamphor Sulfonic Acid active pharmaceutical ingredient (API) or Terephthalylidene Dicamphor Sulfonic Acid finished formulations upon request. The Terephthalylidene Dicamphor Sulfonic Acid suppliers may include Terephthalylidene Dicamphor Sulfonic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Terephthalylidene Dicamphor Sulfonic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terephthalylidene Dicamphor Sulfonic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Terephthalylidene Dicamphor Sulfonic Acid active pharmaceutical ingredient (API) in detail. Different forms of Terephthalylidene Dicamphor Sulfonic Acid DMFs exist exist since differing nations have different regulations, such as Terephthalylidene Dicamphor Sulfonic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terephthalylidene Dicamphor Sulfonic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Terephthalylidene Dicamphor Sulfonic Acid USDMF includes data on Terephthalylidene Dicamphor Sulfonic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terephthalylidene Dicamphor Sulfonic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terephthalylidene Dicamphor Sulfonic Acid suppliers with USDMF on PharmaCompass.
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