01 1Heraeus Precious Metals GmbH & Co. K.G.
01 1Arsenic trioxide
01 1Germany
Registration Number : 224MF10077
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2012-04-08
Latest Date of Registration : 2014-09-30
A Arsenic Trioxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arsenic Trioxide, including repackagers and relabelers. The FDA regulates Arsenic Trioxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arsenic Trioxide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Arsenic Trioxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arsenic Trioxide supplier is an individual or a company that provides Arsenic Trioxide active pharmaceutical ingredient (API) or Arsenic Trioxide finished formulations upon request. The Arsenic Trioxide suppliers may include Arsenic Trioxide API manufacturers, exporters, distributors and traders.
click here to find a list of Arsenic Trioxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Arsenic Trioxide Drug Master File in Japan (Arsenic Trioxide JDMF) empowers Arsenic Trioxide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Arsenic Trioxide JDMF during the approval evaluation for pharmaceutical products. At the time of Arsenic Trioxide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Arsenic Trioxide suppliers with JDMF on PharmaCompass.
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