Bepotastine Besilate
KDMF Registration Details
Bepotastine Besilate
Korea DMF Database
Drug Master Files registered with Korea's MFDS (Ministry of Food and Drug Safety).
- Total Records 13
- Last Modified 2026-05-20
- Data Source MFDS
- Last Updated 2026-05-20
DMF Records Timeline (13 records)
Product
Bepotastine besylate
Registration Number
20190926-209-J-357
Initial Registration
2019-09-26
Last Modified
-
MFDS Classification
Appendix 1
Country
India
Manufacturer
Bal Pharma Limited
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2021
Manufacturing Facility
61-B, Bommasandra Industrial Area Bangalore-560 099, India
Product
Bepotastine besylate
Registration Number
20210630-209-J-1048
Initial Registration
2021-06-30
Last Modified
-
MFDS Classification
Appendix 1
Country
korea
Manufacturer
Daebong LS Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year:
Manufacturing Facility
122B-9L, 123, Neungheodae-ro 649beon-gil, Namdong-gu, Incheon
Product
Bepotastine besylate
Registration Number
20251128-209-J-2073
Initial Registration
2025-11-28
Last Modified
-
MFDS Classification
Appendix 1
Country
korea
Manufacturer
Dongbang FTL Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year:
Manufacturing Facility
78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20241107-209-J-1713
Initial Registration
2024-11-07
Last Modified
2026-04-06
MFDS Classification
Appendix 1
Manufacturer
Aurisco Pharmaceutical Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2025
Manufacturing Facility
8, Balan Gongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea @ Badu Industrial Park Zone, Tiantai, Zhejiang Province 317200, PR China
Product
Bepotastine besylate
Registration Number
20180621-209-J-237
Initial Registration
2018-06-21
Last Modified
2022-11-30
MFDS Classification
Appendix 1
Country
korea
Manufacturer
Hana Pharmaceutical Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2025
Manufacturing Facility
133, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20220204-209-J-1226
Initial Registration
2022-02-04
Last Modified
-
MFDS Classification
Appendix 1
Country
korea
Manufacturer
Hanseo Chem Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2025
Manufacturing Facility
41 Poseunggongdan-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20171208-209-J-64
Initial Registration
2017-12-08
Last Modified
2024-05-30
MFDS Classification
Appendix 1
Country
korea
Manufacturer
HL Genomics Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2024
Manufacturing Facility
1552 Bogaewonsam-ro, Wonsam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20240911-209-J-1689
Initial Registration
2024-09-11
Last Modified
2026-05-20
MFDS Classification
Appendix 1
Country
korea
Manufacturer
Kyungdong Pharmaceutical Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2025
Manufacturing Facility
15, Balangongdan-ro 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20260406-209-J-2170
Initial Registration
2026-04-06
Last Modified
-
MFDS Classification
Appendix 1
Country
china
Manufacturer
Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year:
Manufacturing Facility
No. 6, Huanan 1st Road, Yanjia Avenue, Changshou District, Chongqing 401221, China
Product
Bepotastine besylate
Registration Number
20190401-209-J-327
Initial Registration
2019-04-01
Last Modified
2022-01-10
MFDS Classification
Appendix 1
Country
korea
Manufacturer
Pharmacostec Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2025
Manufacturing Facility
Block 35-2, Balan Regional Industrial Complex, 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20260130-209-J-2125
Initial Registration
2026-01-30
Last Modified
2026-04-30
MFDS Classification
Appendix 1
Country
korea
Manufacturer
SPC Co., Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year:
Manufacturing Facility
386, Pyeongtaekhangman-gil, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20210713-209-J-1067
Initial Registration
2021-07-13
Last Modified
2025-11-12
MFDS Classification
Appendix 1
Manufacturer
ST Pharm Co., Ltd. @ Pharmacostec Co., Ltd.
Identifiers
Withdrawal Date: 2025-11-12
Final Annual Reporting Year: 2025
Manufacturing Facility
171, Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do @ Block 35-2, Balan Regional Industrial Complex, 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Product
Bepotastine besylate
Registration Number
20210409-209-J-702
Initial Registration
2021-04-09
Last Modified
-
MFDS Classification
Appendix 1
Country
japan
Manufacturer
Ube Chemical Factory, Ube Industries, Ltd.
Identifiers
Withdrawal Date: -
Final Annual Reporting Year: 2023
Manufacturing Facility
1978-10, Kogushi, Ube, Yamaguchi, Japan
Status Breakdown
13 total- Active
- Withdrawal
Official Source
All data is obtained from the official MFDS (Ministry of Food and Drug Safety, Korea) database.
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