01 1HANMI FINE CHEMICAL CO. , LTD.
02 1Kyongbo Pharmaceutical Co. , Ltd.
03 1Orchid Chemicals & Pharmaceuticals Limited
04 1Qilu Antibiotics Pharmaceutical Co. , Ltd.
05 1Zhejiang Apeloa Tospo Pharmaceutical Co. , Ltd.
01 2Cefixime
02 1Cefixime Hydrate
03 2Cefixime hydrate
01 2China
02 1India
03 2South Korea
Registration Number : 217MF10415
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2016-02-08
Registration Number : 224MF10092
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2012-04-25
Latest Date of Registration : 2012-04-25
Registration Number : 222MF10120
Registrant's Address : Orchid Towers, 313, Valluvar Kottam High Road, Nungambakkam, Chennai-600 034 India
Initial Date of Registration : 2010-04-02
Latest Date of Registration : 2010-04-02
Registration Number : 226MF10199
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2014-10-27
Latest Date of Registration : 2023-08-02
Registration Number : 302MF10060
Registrant's Address : No. 519 Jiangnan Road, Hengdian Industrial Zone, Dongyang City, Jinhua, Zhejiang Prov...
Initial Date of Registration : 2020-05-25
Latest Date of Registration : 2020-05-25
A Oroken manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oroken, including repackagers and relabelers. The FDA regulates Oroken manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oroken 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 Oroken manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oroken supplier is an individual or a company that provides Oroken active pharmaceutical ingredient (API) or Oroken finished formulations upon request. The Oroken suppliers may include Oroken API manufacturers, exporters, distributors and traders.
click here to find a list of Oroken 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 Oroken Drug Master File in Japan (Oroken JDMF) empowers Oroken 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 Oroken JDMF during the approval evaluation for pharmaceutical products. At the time of Oroken 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 Oroken suppliers with JDMF on PharmaCompass.
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