01 1Lunan New Time Bio-tech Co. , Ltd.
02 2Zhejiang Ausun Pharmaceutical Co. , Ltd.
03 1Zhejiang Medicine Co. , Ltd. Xinchang Pharmaceutical Factory
01 4Miglitol
01 4China
Registration Number : 228MF10006
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2016-01-08
Latest Date of Registration : 2020-08-05
Registration Number : 228MF10052
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2016-02-18
Latest Date of Registration : 2016-02-18
Registration Number : 305MF10034
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2023-03-15
Latest Date of Registration : 2023-03-15
Registration Number : 227MF10281
Registrant's Address : 59 East Huancheng Road, Xinchang, Zhejiang, P. R. China
Initial Date of Registration : 2015-12-15
Latest Date of Registration : 2019-01-24
A Miglitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miglitol, including repackagers and relabelers. The FDA regulates Miglitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miglitol 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 Miglitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Miglitol supplier is an individual or a company that provides Miglitol active pharmaceutical ingredient (API) or Miglitol finished formulations upon request. The Miglitol suppliers may include Miglitol API manufacturers, exporters, distributors and traders.
click here to find a list of Miglitol 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 Miglitol Drug Master File in Japan (Miglitol JDMF) empowers Miglitol 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 Miglitol JDMF during the approval evaluation for pharmaceutical products. At the time of Miglitol 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 Miglitol suppliers with JDMF on PharmaCompass.
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