01 1Lonza Biologics Inc.
01 1Ofatumumab
01 1U.S.A
Registration Number : 224MF10088
Registrant's Address : 101 International Drive Pease International Trade Port Portsmouth New Hampshire 03801...
Initial Date of Registration : 2012-04-25
Latest Date of Registration : 2020-12-07
A Ofatumumab manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ofatumumab, including repackagers and relabelers. The FDA regulates Ofatumumab manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ofatumumab 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 Ofatumumab supplier is an individual or a company that provides Ofatumumab active pharmaceutical ingredient (API) or Ofatumumab finished formulations upon request. The Ofatumumab suppliers may include Ofatumumab API manufacturers, exporters, distributors and traders.
click here to find a list of Ofatumumab 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 Ofatumumab Drug Master File in Japan (Ofatumumab JDMF) empowers Ofatumumab 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 Ofatumumab JDMF during the approval evaluation for pharmaceutical products. At the time of Ofatumumab 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 Ofatumumab suppliers with JDMF on PharmaCompass.
We have 1 companies offering Ofatumumab
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
