01 2Merck Serono S. A.
01 2Cetuximab concentrated bulk
01 2Germany
Registration Number : 305MF10129
Registrant's Address : Zone industriale de l'Auriettaz, Rue de l'Auriette 151, 1170 Aubonne, Switzerland
Initial Date of Registration : 2023-12-06
Latest Date of Registration : 2023-12-06
Registration Number : 301MF10063
Registrant's Address : Zone industriale de l'Auriettaz, Rue de l'Auriette 151, 1170 Aubonne, Switzerland
Initial Date of Registration : 2019-09-11
Latest Date of Registration : 2020-08-05
A Cetuximab manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetuximab, including repackagers and relabelers. The FDA regulates Cetuximab manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetuximab 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 Cetuximab manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetuximab supplier is an individual or a company that provides Cetuximab active pharmaceutical ingredient (API) or Cetuximab finished formulations upon request. The Cetuximab suppliers may include Cetuximab API manufacturers, exporters, distributors and traders.
click here to find a list of Cetuximab 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 Cetuximab Drug Master File in Japan (Cetuximab JDMF) empowers Cetuximab 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 Cetuximab JDMF during the approval evaluation for pharmaceutical products. At the time of Cetuximab 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 Cetuximab suppliers with JDMF on PharmaCompass.
We have 1 companies offering Cetuximab
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
