01 1Glenmark Life Sciences Limited
02 2ILDONG PHARMACEUTICAL CO. , LTD.
03 1Janssen Pharmaceuticals, Inc.
04 1ScinoPharm Taiwan, Ltd.
05 1Siegfried Ltd
01 6Topiramate
01 1India
02 2South Korea
03 1Switzerland
04 1Taiwan
05 1U.S.A
Registration Number : 227MF10208
Registrant's Address : Glenmark House, HDO Corporate Building, Wing A, B. D. Sawant Marg, Chakala, Off Weste...
Initial Date of Registration : 2015-08-11
Latest Date of Registration : 2016-12-14
Registration Number : 227MF10206
Registrant's Address : 2. Baumoe-ro 27-gil, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2015-08-10
Latest Date of Registration : 2016-09-08
Registration Number : 301MF10026
Registrant's Address : 2. Baumoe-ro 27-gil, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2019-07-04
Latest Date of Registration : 2019-07-04
Registration Number : 220MF10001
Registrant's Address : 1440 Olympic Drive, Athens, GA 30601, USA
Initial Date of Registration : 2008-01-09
Latest Date of Registration : 2008-09-19
Registration Number : 301MF10073
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
Initial Date of Registration : 2019-10-08
Latest Date of Registration : 2023-09-06
Registration Number : 229MF10116
Registrant's Address : Untere Bru(¨)hlstrasse 4, CH-4800 Zofingen Switzerland
Initial Date of Registration : 2017-07-05
Latest Date of Registration : 2017-07-05
A Topiramate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topiramate, including repackagers and relabelers. The FDA regulates Topiramate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topiramate 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 Topiramate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topiramate supplier is an individual or a company that provides Topiramate active pharmaceutical ingredient (API) or Topiramate finished formulations upon request. The Topiramate suppliers may include Topiramate API manufacturers, exporters, distributors and traders.
click here to find a list of Topiramate 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 Topiramate Drug Master File in Japan (Topiramate JDMF) empowers Topiramate 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 Topiramate JDMF during the approval evaluation for pharmaceutical products. At the time of Topiramate 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 Topiramate suppliers with JDMF on PharmaCompass.
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