01 1AGC Inc.
02 1HyClone Laboratories, Inc.
03 1SAFC Biosciences, Inc.
04 1SOLVAY PEROXYTHAI LIMITED.
05 1Tokuyama Corporation
06 1Tosoh Corporation
01 1Japanese Pharmacopoeia sodium bicarbonate (production only)
02 1Medium / medium additive · EX-CELL (TM) 302 (Modified 6827 2C) Animal Component Free Media w / o Sodium Bicarbonate
03 1Medium / medium additive · SH30549 SFM4CHO with L-Glut amine with 2.2g / L Sodium Bicarbonate
04 1Sodium Hydrogen Carbonate
05 1Sodium bicarbonate
06 1Sodium bicarbonate (production only) Japanese Pharmacopoeia sodium bicarbonate
01 1Italy
02 2Japan
03 1Netherlands
04 2U.S.A
Sodium bicarbonate (for manufacturing only) Japanese Pharmacopoeia Sodium hydrogen carbonate
Registration Number : 217MF10305
Registrant's Address : 1-5-1 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-30
Latest Date of Registration : 2006-07-20
Registration Number : 229MF40008
Registrant's Address : 925 West 1800 South Logan Utah 84321 USA
Initial Date of Registration : 2017-03-22
Latest Date of Registration : 2017-03-22
Registration Number : 230MF40003
Registrant's Address : 13804 West 107th Street Lenexa, Kansas 66215 USA
Initial Date of Registration : 2018-01-15
Latest Date of Registration : 2018-01-15
Registration Number : 302MF10098
Registrant's Address : 11TH & 16TH FLOOR, WAVE PLACE, 55 WIRELESS ROAD, LUMPINI, Pathumwan, Bangkok 10330, T...
Initial Date of Registration : 2020-08-05
Latest Date of Registration : 2020-08-05
Japanese Pharmacopoeia Sodium Bicarbonate (for manufacturing only)
Registration Number : 222MF10044
Registrant's Address : 1-1 Mikage-cho, Shunan City, Yamaguchi Prefecture
Initial Date of Registration : 2010-02-09
Latest Date of Registration : 2010-02-09
Registration Number : 221MF10148
Registrant's Address : 4560 Kaiseicho, Shunan City, Yamaguchi Prefecture
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2009-07-09
A Sodium Bicarbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Bicarbonate, including repackagers and relabelers. The FDA regulates Sodium Bicarbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Bicarbonate 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 Sodium Bicarbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Bicarbonate supplier is an individual or a company that provides Sodium Bicarbonate active pharmaceutical ingredient (API) or Sodium Bicarbonate finished formulations upon request. The Sodium Bicarbonate suppliers may include Sodium Bicarbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Bicarbonate 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 Sodium Bicarbonate Drug Master File in Japan (Sodium Bicarbonate JDMF) empowers Sodium Bicarbonate 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 Sodium Bicarbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Bicarbonate 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 Sodium Bicarbonate suppliers with JDMF on PharmaCompass.
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