Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 1Bal Pharma Limited
02 1Aurisco Pharmaceutical Co., Ltd.
03 1Daebong LS Co., Ltd.
04 1Estifarm Co., Ltd. @Pharmacostech Co., Ltd.
05 2H.L.G.Nomics Co., Ltd.
06 1Hanapharmaceutical Co., Ltd.
07 1Hanmi Precision Chemical Co., Ltd.
08 1Hanseochem Co., Ltd.
09 1Kyungdong Pharmaceutical Co., Ltd.
10 1Pharmacostec Co., Ltd.
11 1Ube Chemical Factory, Ube Industries, Ltd.
12 1Youngjin Pharmaceutical Co., Ltd.
01 1Ace Biopharm Co., Ltd.
02 1Daebong LS Co., Ltd.
03 1Dong-A ST Co., Ltd.
04 1Estifarm Co., Ltd.
05 2H.L.G.Nomics Co., Ltd.
06 1Hanapharmaceutical Co., Ltd.
07 1Hanmi Precision Chemical Co., Ltd.
08 1Hanseochem Co., Ltd.
09 1Kukjeon Pharmaceutical Co., Ltd.
10 1Kyungdong Pharmaceutical Co., Ltd.
11 1Pharmacostec Co., Ltd.
12 1Youngjin Pharmaceutical Co., Ltd.
01 10Bepotastine besilate
02 1Bepotastine calcium dihydrate
03 1Bepotastine nicotinate
04 1Bepotastine salicylate
01 1China
02 1Germany
03 1India
04 10South Korea
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2019-09-26
Registration Number : 20190926-209-J-357
Manufacturer Name : Bal Pharma Limited
Manufacturer Address : 61-B, Bommasandra Industrial Area Bangalore-560 099, India
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2024-11-07
Registration Number : 20241107-209-J-1713
Manufacturer Name : Aurisco Pharmaceutical Co., ...
Manufacturer Address : 8, Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ Badu Industr...
Registrant Name : Daebong LS Co., Ltd.
Registration Date : 2021-06-30
Registration Number : 20210630-209-J-1048
Manufacturer Name : Daebong LS Co., Ltd.
Manufacturer Address : 122B-9L, 123, Neungheodae-ro 649beon-gil, Namdong-gu, Incheon
Registrant Name : Hanmi Precision Chemical Co., Ltd.
Registration Date : 2022-04-18
Registration Number : 20220418-209-J-1267
Manufacturer Name : Hanmi Precision Chemical Co....
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do (1248-10)
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2022-02-04
Registration Number : 20220204-209-J-1226
Manufacturer Name : Hanseochem Co., Ltd.
Manufacturer Address : 41 Poseung Industrial Complex-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2024-09-11
Registration Number : 20240911-209-J-1689
Manufacturer Name : Kyungdong Pharmaceutical Co....
Manufacturer Address : 15, Balan Industrial Complex Road 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Pharmacostec Co., Ltd.
Registration Date : 2019-04-01
Registration Number : 20190401-209-J-327
Manufacturer Name : Pharmacostec Co., Ltd.
Manufacturer Address : Block 35-2, Balan Local Industrial Complex, 47, Pharmaceutical Complex, Hyangnam-eup,...
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2021-07-13
Registration Number : 20210713-209-J-1067
Manufacturer Name : Estifarm Co., Ltd. @Pharmaco...
Manufacturer Address : Gyeonggi-do Ansan-si Danwon-gu Haean-ro 171@Gyeonggi-do Hwaseong-si Hyangnam-eup Yakj...
Registrant Name : Dong-A ST Co., Ltd.
Registration Date : 2021-04-09
Registration Number : 20210409-209-J-702
Manufacturer Name : Ube Chemical Factory, Ube In...
Manufacturer Address : 1978-10, Kogushi, Ube, Yamaguchi, Japan
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2021-02-24
Registration Number : 20210224-209-J-847
Manufacturer Name : Youngjin Pharmaceutical Co.,...
Manufacturer Address : 21 Wanju Industrial Complex 5-ro, Bongdong-eup, Wanju-gun, Jeollabuk-do Special Self-...
A Bepotastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bepotastine, including repackagers and relabelers. The FDA regulates Bepotastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bepotastine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bepotastine supplier is an individual or a company that provides Bepotastine active pharmaceutical ingredient (API) or Bepotastine finished formulations upon request. The Bepotastine suppliers may include Bepotastine API manufacturers, exporters, distributors and traders.
click here to find a list of Bepotastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bepotastine Drug Master File in Korea (Bepotastine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bepotastine. The MFDS reviews the Bepotastine KDMF as part of the drug registration process and uses the information provided in the Bepotastine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bepotastine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bepotastine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bepotastine suppliers with KDMF on PharmaCompass.
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