01 1PRAXAIR CANADA INC
01 1XENON GAS
01 1Canada
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32548
Submission : 2018-03-29
Status : Active
Type : II
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PharmaCompass offers a list of Xenon API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Xenon manufacturer or Xenon supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Xenon manufacturer or Xenon supplier.
A Xenon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xenon, including repackagers and relabelers. The FDA regulates Xenon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xenon 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 Xenon supplier is an individual or a company that provides Xenon active pharmaceutical ingredient (API) or Xenon finished formulations upon request. The Xenon suppliers may include Xenon API manufacturers, exporters, distributors and traders.
click here to find a list of Xenon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Xenon DMF (Drug Master File) is a document detailing the whole manufacturing process of Xenon active pharmaceutical ingredient (API) in detail. Different forms of Xenon DMFs exist exist since differing nations have different regulations, such as Xenon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xenon DMF submitted to regulatory agencies in the US is known as a USDMF. Xenon USDMF includes data on Xenon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xenon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xenon suppliers with USDMF on PharmaCompass.
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