Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 2FARMAK, a. s.
02 1YS Life Science Co. , Ltd.
01 1 Bromfenac Sodium
02 1Bromfenac Sodium
03 1Bromfenac sodium hydrate "production-only"
01 2Czech Republic
02 1South Korea
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registration Number : 306MF10119
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic
Initial Date of Registration : 2024-09-03
Latest Date of Registration : 2024-09-03
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registration Number : 230MF10078
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic
Initial Date of Registration : 2018-07-03
Latest Date of Registration : 2018-07-03
Bromfenac sodium hydrate (for manufacturing purposes only)
Registration Number : 223MF10031
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2011-03-03
Latest Date of Registration : 2023-04-19
A Bromfenac Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromfenac Sodium, including repackagers and relabelers. The FDA regulates Bromfenac Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromfenac Sodium 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 Bromfenac Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromfenac Sodium supplier is an individual or a company that provides Bromfenac Sodium active pharmaceutical ingredient (API) or Bromfenac Sodium finished formulations upon request. The Bromfenac Sodium suppliers may include Bromfenac Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Bromfenac Sodium 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 Bromfenac Sodium Drug Master File in Japan (Bromfenac Sodium JDMF) empowers Bromfenac Sodium 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 Bromfenac Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Bromfenac Sodium 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 Bromfenac Sodium suppliers with JDMF on PharmaCompass.
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