01 1DONGBANG FUTURE TECH & LIFE CO. , LTD.
02 1Ryoto Fine Co., Ltd.
01 2Mitiglinide calcium hydrate
01 1Japan
02 1South Korea
Registration Number : 229MF10057
Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2017-03-03
Latest Date of Registration : 2017-04-11
Registration Number : 227MF10191
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2015-08-03
Latest Date of Registration : 2015-08-03
A Mitiglinide Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitiglinide Calcium, including repackagers and relabelers. The FDA regulates Mitiglinide Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitiglinide Calcium 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 Mitiglinide Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitiglinide Calcium supplier is an individual or a company that provides Mitiglinide Calcium active pharmaceutical ingredient (API) or Mitiglinide Calcium finished formulations upon request. The Mitiglinide Calcium suppliers may include Mitiglinide Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Mitiglinide Calcium 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 Mitiglinide Calcium Drug Master File in Japan (Mitiglinide Calcium JDMF) empowers Mitiglinide Calcium 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 Mitiglinide Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Mitiglinide Calcium 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 Mitiglinide Calcium suppliers with JDMF on PharmaCompass.
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