01 1Biocon Limited
02 2BrightGene Pharmaceutical Co. , Ltd.
03 1Shanghai Tianwei Biopharmaceutical Co., Ltd.
04 1Yung Shin Pharmaceutical Ind. Co. , Ltd.
01 2MICAFUNGIN SODIUM
02 1Micafungin Sodium
03 1Micafungin Sodium (TMC)
04 1Micafungin sodium hydrate
01 4China
02 1India
Registration Number : 230MF10166
Registrant's Address : 20th KM, Hosur Road, Electronics City-560100, Bengaluru, India
Initial Date of Registration : 2018-12-10
Latest Date of Registration : 2021-01-20
Registration Number : 230MF10169
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2018-12-19
Latest Date of Registration : 2021-11-17
Registration Number : 303MF10069
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2021-04-19
Latest Date of Registration : 2021-04-19
Registration Number : 229MF10162
Registrant's Address : No. 4258 Jindu Road, Shanghai, China
Initial Date of Registration : 2017-08-22
Latest Date of Registration : 2017-08-22
Micafungin Sodium "Yung Shin" Micafungin Sodium "Yung Shin"
Registration Number : 301MF10054
Registrant's Address : No. 1191, Sec. 1, Chung Shan Rd. , Tachia, Taichung, Taiwan, R. O. C.
Initial Date of Registration : 2019-08-28
Latest Date of Registration : 2022-03-02
A Micafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Micafungin, including repackagers and relabelers. The FDA regulates Micafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Micafungin 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 Micafungin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Micafungin supplier is an individual or a company that provides Micafungin active pharmaceutical ingredient (API) or Micafungin finished formulations upon request. The Micafungin suppliers may include Micafungin API manufacturers, exporters, distributors and traders.
click here to find a list of Micafungin 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 Micafungin Drug Master File in Japan (Micafungin JDMF) empowers Micafungin 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 Micafungin JDMF during the approval evaluation for pharmaceutical products. At the time of Micafungin 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 Micafungin suppliers with JDMF on PharmaCompass.
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