01 1SALSBURY CHEMICALS INC
01 13-NITRO-4-HYDROXYPHENYLARSONIC ACID
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 491
Submission : 1962-06-27
Status : Inactive
Type : II
A Roxarsone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxarsone, including repackagers and relabelers. The FDA regulates Roxarsone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxarsone 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 Roxarsone supplier is an individual or a company that provides Roxarsone active pharmaceutical ingredient (API) or Roxarsone finished formulations upon request. The Roxarsone suppliers may include Roxarsone API manufacturers, exporters, distributors and traders.
click here to find a list of Roxarsone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Roxarsone DMF (Drug Master File) is a document detailing the whole manufacturing process of Roxarsone active pharmaceutical ingredient (API) in detail. Different forms of Roxarsone DMFs exist exist since differing nations have different regulations, such as Roxarsone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Roxarsone DMF submitted to regulatory agencies in the US is known as a USDMF. Roxarsone USDMF includes data on Roxarsone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roxarsone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Roxarsone suppliers with USDMF on PharmaCompass.
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