01 1Asahi Kasei Finechem Co., Ltd.
02 1Changzhou Yingsheng Pharmaceutical Co. , Ltd.
03 1Cheer Fine Pharmaceutical Co. , Ltd.
04 1Hunan Dongting Pharmaceutical Co. , Ltd.
05 1Kyowa Pharma Chemical Co., Ltd.
06 2Yantai Valiant Pharmaceutical Co. , Ltd.
01 2Japanese Pharmacopoeia tranexamic acid (production only)
02 2Tranexamic Acid
03 2Tranexamic acid
04 1Tranexamic acid (JP)
01 5China
02 2Japan
Japanese Pharmacopoeia Tranexamic Acid (for manufacturing only)
Registration Number : 218MF10210
Registrant's Address : 3-3-23 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2007-08-01
Registration Number : 304MF10039
Registrant's Address : Weitang Chemical Zone, Xinbei District, Changzhou, Jiangsu Province, P. R. China
Initial Date of Registration : 2022-02-17
Latest Date of Registration : 2022-02-17
Registration Number : 302MF10100
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2020-08-18
Latest Date of Registration : 2021-12-02
Registration Number : 223MF10004
Registrant's Address : No. 16, Dongyan Road, Deshan, Changde City, Hunan Province, China
Initial Date of Registration : 2011-01-14
Latest Date of Registration : 2011-01-14
Japanese Pharmacopoeia Tranexamic Acid (for manufacturing only)
Registration Number : 224MF10082
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2012-04-13
Latest Date of Registration : 2012-04-13
Registration Number : 229MF10217
Registrant's Address : No. 60 Taiyuan Rd. , Dajijia Industrial Park, YEDA Yantai, Shandong China
Initial Date of Registration : 2017-12-08
Latest Date of Registration : 2017-12-08
Registration Number : 225MF10015
Registrant's Address : No. 60 Taiyuan Rd. , Dajijia Industrial Park, YEDA Yantai, Shandong China
Initial Date of Registration : 2013-01-31
Latest Date of Registration : 2013-01-31
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A CAS-1197-18-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-1197-18-8, including repackagers and relabelers. The FDA regulates CAS-1197-18-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-1197-18-8 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CAS-1197-18-8 supplier is an individual or a company that provides CAS-1197-18-8 active pharmaceutical ingredient (API) or CAS-1197-18-8 finished formulations upon request. The CAS-1197-18-8 suppliers may include CAS-1197-18-8 API manufacturers, exporters, distributors and traders.
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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 CAS-1197-18-8 Drug Master File in Japan (CAS-1197-18-8 JDMF) empowers CAS-1197-18-8 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 CAS-1197-18-8 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-1197-18-8 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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