01 2Cheer Fine Pharmaceutical Co. , Ltd.
02 2Daiwa Pharmaceutical Industries Co., Ltd.
03 1Dong Wha Pharm. Ind. Co. , Ltd.
04 2ESTECHPHARMA CO. , LTD.
05 1INIST ST CO. , LTD.
06 3Jiangxi Synergy Pharmaceutical Co. , Ltd.
07 1Nissei Chemical Industry Co., Ltd.
08 1Polaris AI Pharma Corp.
09 1SAM-OH PHARM. C.O. ,LTD
10 1Saurav Chemicals Limited
11 1Shasun Pharmaceuticals Limited
12 1Strides Shasun Limited
13 2Zenji Pharmaceuticals (Suzhou) Ltd.
14 2Zhejiang Liaoyuan Pharmaceutical Co. , Ltd.
01 1Japanese Pharmacopoeia Drug rebamipide (production only)
02 1Japanese Pharmacopoeia outside rebamipide (production only)
03 1Japanese Pharmacopoeia rebamipide
04 2Outsiders regulations rebamipide (production only)
05 2REBAMIPIDE
06 1REBAMIPIDE JP
07 6Rebamipide
08 1Rebamipide
09 1Rebamipide "M"
10 1Rebamipide "S"
11 1Rebamipide (M)
12 2Rebamipide (production only)
13 1Rebamipide [SS]
01 9China
02 1Gabon
03 4India
04 1Japan
05 6South Korea
Registration Number : 229MF10024
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2017-01-31
Latest Date of Registration : 2017-01-31
Rebamipide (for manufacturing only)
Registration Number : 224MF10123
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2012-07-09
Latest Date of Registration : 2012-07-09
Registration Number : 228MF10089
Registrant's Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, P. R. China
Initial Date of Registration : 2016-04-15
Latest Date of Registration : 2016-04-15
Japanese Pharmacopoeia Rebamipide
Registration Number : 229MF10220
Registrant's Address : Plot No. 370, Industrial Area, Phase-II, Panchkula, Haryana State, India
Initial Date of Registration : 2017-12-18
Latest Date of Registration : 2017-12-18
Registration Number : 227MF10124
Registrant's Address : The Batra Center, No. 28, Sardar Patel Road, Guindy, Chennai 600 032. India
Initial Date of Registration : 2015-04-22
Latest Date of Registration : 2015-04-22
Registration Number : 305MF10002
Registrant's Address : 122, Xuqing Road, Xuguan Industry Park Suzhou, Jiangsu P. R. China
Initial Date of Registration : 2023-01-11
Latest Date of Registration : 2023-01-11
Registration Number : 223MF10143
Registrant's Address : 122, Xuqing Road, Xuguan Industry Park Suzhou, Jiangsu P. R. China
Initial Date of Registration : 2011-09-28
Latest Date of Registration : 2013-12-18
Registration Number : 228MF10085
Registrant's Address : The Batra Center, No. 28, Sardar Patel Road, Guindy, Chennai 600 032. India
Initial Date of Registration : 2016-04-06
Latest Date of Registration : 2016-04-06
Registration Number : 224MF10078
Registrant's Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Duqiao town, L...
Initial Date of Registration : 2012-03-30
Latest Date of Registration : 2013-06-11
Registration Number : 230MF10081
Registrant's Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Duqiao town, L...
Initial Date of Registration : 2018-07-09
Latest Date of Registration : 2018-07-09
A Rebamipide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rebamipide, including repackagers and relabelers. The FDA regulates Rebamipide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rebamipide 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 Rebamipide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rebamipide supplier is an individual or a company that provides Rebamipide active pharmaceutical ingredient (API) or Rebamipide finished formulations upon request. The Rebamipide suppliers may include Rebamipide API manufacturers, exporters, distributors and traders.
click here to find a list of Rebamipide 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 Rebamipide Drug Master File in Japan (Rebamipide JDMF) empowers Rebamipide 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 Rebamipide JDMF during the approval evaluation for pharmaceutical products. At the time of Rebamipide 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 Rebamipide suppliers with JDMF on PharmaCompass.
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