01 1Apicore US LLC
02 1Jiangsu Hansoh Pharmaceutical Group Co. , Ltd.
03 1LAURUS LABS LIMITED.
04 1Nippon Kayaku Co., Ltd.
05 2Shiratori Pharmaceutical Co., Ltd.
01 2Bortezomib
02 1Bortezomib "NK"
03 1Bortezomib Hydrate
04 1Bortezomib production dedicated
05 1Bortezomib production only
01 1China
02 2India
03 3Japan
Registration Number : 231MF10057
Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA
Initial Date of Registration : 2019-02-25
Latest Date of Registration : 2019-02-25
Registration Number : 230MF10045
Registrant's Address : 9 Dongjin Road, Economic & Technical Development Zone, Lianyungang, Jiangsu 222069, C...
Initial Date of Registration : 2018-03-22
Latest Date of Registration : 2018-03-22
Registration Number : 228MF10207
Registrant's Address : 2nd Floor, Serene Chambers, Road No#7, Banjara Hills, Hyderabad, Telangana, INDIA
Initial Date of Registration : 2016-11-02
Latest Date of Registration : 2020-02-27
Registration Number : 230MF10025
Registrant's Address : 2-1-1 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2018-02-15
Latest Date of Registration : 2018-02-15
Bortezomib Manufacturing Exclusive
Registration Number : 301MF10086
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2019-10-29
Latest Date of Registration : 2019-10-29
Bortezomib Manufacturing Exclusive
Registration Number : 229MF10148
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2017-07-31
Latest Date of Registration : 2017-07-31
A Bortezomib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bortezomib, including repackagers and relabelers. The FDA regulates Bortezomib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bortezomib 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 Bortezomib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bortezomib supplier is an individual or a company that provides Bortezomib active pharmaceutical ingredient (API) or Bortezomib finished formulations upon request. The Bortezomib suppliers may include Bortezomib API manufacturers, exporters, distributors and traders.
click here to find a list of Bortezomib 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 Bortezomib Drug Master File in Japan (Bortezomib JDMF) empowers Bortezomib 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 Bortezomib JDMF during the approval evaluation for pharmaceutical products. At the time of Bortezomib 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 Bortezomib suppliers with JDMF on PharmaCompass.
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