01 1Heraeus Precious Metals GmbH & Co. K.G.
01 1Thiotepa
01 1Germany
Registration Number : 229MF10141
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2017-07-25
Latest Date of Registration : 2019-01-21
A Thiotepa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiotepa, including repackagers and relabelers. The FDA regulates Thiotepa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiotepa 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 Thiotepa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Thiotepa supplier is an individual or a company that provides Thiotepa active pharmaceutical ingredient (API) or Thiotepa finished formulations upon request. The Thiotepa suppliers may include Thiotepa API manufacturers, exporters, distributors and traders.
click here to find a list of Thiotepa 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 Thiotepa Drug Master File in Japan (Thiotepa JDMF) empowers Thiotepa 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 Thiotepa JDMF during the approval evaluation for pharmaceutical products. At the time of Thiotepa 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 Thiotepa suppliers with JDMF on PharmaCompass.
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