01 1HANMI FINE CHEMICAL CO. , LTD.
02 1HL Genomics
03 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
04 1Ryoto Fine Co., Ltd.
05 1UBE Inc.
01 2Bepotastine besilate
02 1Bepotastine besilate (production only)
03 1Besylate bepotastine
04 1Japanese Pharmacopoeia bepotastine besilate production dedicated
01 3Japan
02 2South Korea
Registration Number : 229MF10032
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2017-02-08
Latest Date of Registration : 2023-06-21
Registration Number : 229MF10070
Registrant's Address : 1552, Bogaewonsam-ro, Wonsam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Ko...
Initial Date of Registration : 2017-04-04
Latest Date of Registration : 2017-04-04
Japanese Pharmacopoeia Bepotastine Besilate For manufacturing only
Registration Number : 229MF10016
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2017-01-25
Latest Date of Registration : 2020-07-06
Bepotastine besilate (for manufacturing purposes only)
Registration Number : 223MF10109
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2011-07-15
Latest Date of Registration : 2012-05-15
Registration Number : 217MF10442
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2024-05-29
A Bepotastine Besilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bepotastine Besilate, including repackagers and relabelers. The FDA regulates Bepotastine Besilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bepotastine Besilate 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 Bepotastine Besilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bepotastine Besilate supplier is an individual or a company that provides Bepotastine Besilate active pharmaceutical ingredient (API) or Bepotastine Besilate finished formulations upon request. The Bepotastine Besilate suppliers may include Bepotastine Besilate API manufacturers, exporters, distributors and traders.
click here to find a list of Bepotastine Besilate 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 Bepotastine Besilate Drug Master File in Japan (Bepotastine Besilate JDMF) empowers Bepotastine Besilate 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 Bepotastine Besilate JDMF during the approval evaluation for pharmaceutical products. At the time of Bepotastine Besilate 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 Bepotastine Besilate suppliers with JDMF on PharmaCompass.
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