01 1Excella GmbH & Co. K.G.
02 1FORMOSA LABORATORIES, INC.
03 1Shilpa Pharma Lifesciences Limited
01 3Temozolomide
01 1India
02 1Luxembourg
03 1Taiwan
Registration Number : 302MF10046
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2020-04-17
Latest Date of Registration : 2020-12-07
Registration Number : 228MF10143
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2016-08-03
Latest Date of Registration : 2020-04-27
Registration Number : 228MF10125
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India
Initial Date of Registration : 2016-07-12
Latest Date of Registration : 2023-02-15
A Temozolomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temozolomide, including repackagers and relabelers. The FDA regulates Temozolomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temozolomide 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 Temozolomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temozolomide supplier is an individual or a company that provides Temozolomide active pharmaceutical ingredient (API) or Temozolomide finished formulations upon request. The Temozolomide suppliers may include Temozolomide API manufacturers, exporters, distributors and traders.
click here to find a list of Temozolomide 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 Temozolomide Drug Master File in Japan (Temozolomide JDMF) empowers Temozolomide 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 Temozolomide JDMF during the approval evaluation for pharmaceutical products. At the time of Temozolomide 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 Temozolomide suppliers with JDMF on PharmaCompass.
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