01 1Alembic Pharmaceuticals Limited
02 1Dijia Pharmaceutical Group Co. , Ltd.
03 1FUJIFILM Wako Chemical Co., Ltd.
04 2HANMI FINE CHEMICAL CO. , LTD.
05 1Shandong Boyuan Pharmaceutical Co. , Ltd.
06 1Tianish Laboratories Private Limited
07 5Zhejiang Ausun Pharmaceutical Co. , Ltd.
01 11Febuxostat
02 1Febuxostat hydrate
01 7China
02 1India
03 1Japan
04 2South Korea
05 1U.S.A
Registration Number : 302MF10156
Registrant's Address : Alembic Road, Vadodara 390003, Gujarat, India
Initial Date of Registration : 2020-12-18
Latest Date of Registration : 2022-11-16
Registration Number : 303MF10010
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2021-01-20
Latest Date of Registration : 2021-11-17
Registration Number : 305MF10121
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2023-11-15
Latest Date of Registration : 2023-11-15
Registration Number : 306MF10122
Registrant's Address : No. 12 Taixing East Street, Jibei Economic Development Zone, Jiyang District, Jinan C...
Initial Date of Registration : 2024-09-11
Latest Date of Registration : 2024-09-11
Registration Number : 303MF10017
Registrant's Address : No. 268 Tianrun Road, Wendeng Economic Development Zone, Weihai, Shandong, China
Initial Date of Registration : 2021-01-26
Latest Date of Registration : 2021-01-26
Registration Number : 303MF10031
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2021-02-10
Latest Date of Registration : 2021-02-10
Registration Number : 303MF10020
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2021-01-28
Latest Date of Registration : 2021-01-28
Registration Number : 303MF10011
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2021-01-20
Latest Date of Registration : 2021-01-20
Registration Number : 303MF10005
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2021-01-07
Latest Date of Registration : 2021-01-07
Registration Number : 305MF10050
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2023-04-19
Latest Date of Registration : 2023-04-19
A Febuxostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Febuxostat, including repackagers and relabelers. The FDA regulates Febuxostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Febuxostat 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 Febuxostat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Febuxostat supplier is an individual or a company that provides Febuxostat active pharmaceutical ingredient (API) or Febuxostat finished formulations upon request. The Febuxostat suppliers may include Febuxostat API manufacturers, exporters, distributors and traders.
click here to find a list of Febuxostat 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 Febuxostat Drug Master File in Japan (Febuxostat JDMF) empowers Febuxostat 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 Febuxostat JDMF during the approval evaluation for pharmaceutical products. At the time of Febuxostat 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 Febuxostat suppliers with JDMF on PharmaCompass.
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