01 1DNP Fine Chemicals Utsunomiya Co., Ltd.
02 1EISAI PHARMACEUTICALS INDIA PVT LTD
03 3Ouchi Shinko Chemical Industry Co., Ltd.
04 1Sanbo Chemical Laboratory Co., Ltd.
05 1Sanyo Chemical Research Institute Co., Ltd.
06 1Xi'an Wanlong Pharmaceutical Co. ,Ltd
07 2Zhejiang East Asia Pharmaceutical Co. , Ltd.
01 3Epalrestat
02 2Epalrestat (production only)
03 1JP Epalrestat (for manufacturing only)
04 2Japanese Pharmacopoeia Epalrestat
05 1Japanese Pharmacopoeia Epalrestat (manufacturing only)
06 1Japanese Pharmacopoeia Epalrestat (production only)
01 3China
02 1Gabon
03 6Japan
Epalrestat (for manufacturing only)
Registration Number : 218MF10360
Registrant's Address : 1062-8 Honjo, Nishikata-cho, Tochigi City, Tochigi Prefecture
Initial Date of Registration : 2006-03-20
Latest Date of Registration : 2014-02-05
Japanese Pharmacopoeia Epalrestat
Registration Number : 229MF10005
Registrant's Address : Visakha Pharmacity Limited (SEZ), Plot Nos. 96,97,98,124 & 126, Parawada-531 019, Ana...
Initial Date of Registration : 2017-01-10
Latest Date of Registration : 2019-06-05
Japanese Pharmacopoeia Epalrestat (for manufacturing only)
Registration Number : 229MF10117
Registrant's Address : 1-31 Kannanbecho, Sakai-ku, Sakai-shi, Osaka
Initial Date of Registration : 2017-07-05
Latest Date of Registration : 2018-02-26
Epalrestat (for manufacturing only)
Registration Number : 217MF10698
Registrant's Address : 7-4, Nihonbashi Kofunecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2008-02-25
Japanese Pharmacopoeia Epalrestat (for manufacturing only)
Registration Number : 301MF10017
Registrant's Address : 7-4, Nihonbashi Kofunecho, Chuo-ku, Tokyo
Initial Date of Registration : 2019-06-07
Latest Date of Registration : 2019-06-07
JP Epalrestat (for manufacturing only)
Registration Number : 306MF10045
Registrant's Address : 7-4, Nihonbashi Kofunecho, Chuo-ku, Tokyo
Initial Date of Registration : 2024-03-21
Latest Date of Registration : 2024-03-21
Japanese Pharmacopoeia Epalrestat
Registration Number : 303MF10164
Registrant's Address : NO. 5, Chuangxin Road, New Industrial Park, Gaoxin District, Xi'an, Shaanxi, China
Initial Date of Registration : 2021-11-17
Latest Date of Registration : 2021-11-17
Registration Number : 224MF10240
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2012-12-28
Latest Date of Registration : 2012-12-28
Registration Number : 219MF10317
Registrant's Address : 23rd Floor, Chamber of Commerce Building North Loading Road, Huangyan, Zhejiang, Chin...
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2007-10-24
Registration Number : 230MF10015
Registrant's Address : 23rd Floor, Chamber of Commerce Building North Laodong Road, Huangyan, Zhejiang, Chin...
Initial Date of Registration : 2018-01-30
Latest Date of Registration : 2018-01-30
A Epalrestat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epalrestat, including repackagers and relabelers. The FDA regulates Epalrestat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epalrestat 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 Epalrestat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epalrestat supplier is an individual or a company that provides Epalrestat active pharmaceutical ingredient (API) or Epalrestat finished formulations upon request. The Epalrestat suppliers may include Epalrestat API manufacturers, exporters, distributors and traders.
click here to find a list of Epalrestat 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 Epalrestat Drug Master File in Japan (Epalrestat JDMF) empowers Epalrestat 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 Epalrestat JDMF during the approval evaluation for pharmaceutical products. At the time of Epalrestat 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 Epalrestat suppliers with JDMF on PharmaCompass.
We have 6 companies offering Epalrestat
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