Bepotastine Besilate Active
KDMF Registration Details

Bepotastine Besilate Active

Korea DMF Database

Drug Master Files registered with Korea's MFDS (Ministry of Food and Drug Safety).

Active 4 countries
  • Total Records 12
  • Last Modified 2026-05-20
  • Data Source MFDS
  • Last Updated 2026-05-20

13

All
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12

Active
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1

Withdrawal
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DMF Records Timeline (12 records)
2019
26 Sep
Ace Biopharm Co., Ltd. Active

Product

Bepotastine besylate

Registration Number

20190926-209-J-357

Initial Registration

2019-09-26

Last Modified

-

MFDS Classification

Appendix 1

Country

India

India

Manufacturer

Bal Pharma Limited

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2021

Manufacturing Facility

61-B, Bommasandra Industrial Area Bangalore-560 099, India

2021
30 Jun
Daebong LS Co., Ltd. Active

Product

Bepotastine besylate

Registration Number

20210630-209-J-1048

Initial Registration

2021-06-30

Last Modified

-

MFDS Classification

Appendix 1

Country

korea

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

2025
28 Nov
Dongbang FTL Co., Ltd. Active

Product

Bepotastine besylate

Registration Number

20251128-209-J-2073

Initial Registration

2025-11-28

Last Modified

-

MFDS Classification

Appendix 1

Country

korea

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

2024
07 Nov
Gukjeon Co., Ltd. Active

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

2018
21 Jun
Hana Pharmaceutical Co., Ltd. Active

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

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

2022
04 Feb
Hanseo Chem Co., Ltd. Active

Product

Bepotastine besylate

Registration Number

20220204-209-J-1226

Initial Registration

2022-02-04

Last Modified

-

MFDS Classification

Appendix 1

Country

korea

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

2017
08 Dec
HL Genomics Co., Ltd. Active

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

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

2024
11 Sep
Kyungdong Pharmaceutical Co., Ltd. Active

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

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

2026
06 Apr
Mothers Pharmaceutical Co., Ltd. Active

Product

Bepotastine besylate

Registration Number

20260406-209-J-2170

Initial Registration

2026-04-06

Last Modified

-

MFDS Classification

Appendix 1

Country

china

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

2019
01 Apr
Pharmacostec Co., Ltd. Active

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

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

2026
30 Jan
SPC Co., Ltd. Active

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

korea

Manufacturer

SPC Co., Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year:

Manufacturing Facility

386, Pyeongtaekhangman-gil, Poseung-eup, Pyeongtaek-si, Gyeonggi-do

2021
09 Apr
Dong-A ST Co., Ltd. Active

Product

Bepotastine besylate

Registration Number

20210409-209-J-702

Initial Registration

2021-04-09

Last Modified

-

MFDS Classification

Appendix 1

Country

japan

japan

Manufacturer

Ube Chemical Factory, Ube Industries, Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2023

Manufacturing Facility

1978-10, Kogushi, Ube, Yamaguchi, Japan

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Status Breakdown
12 total
  • Active
Official Source

All data is obtained from the official MFDS (Ministry of Food and Drug Safety, Korea) database.

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KDMF data is compiled from publicly available Korea Drug Master File (KDMF) regulatory sources.

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