Bepotastine Besilate Active - KDMF Registration Details

Korea DMF Database
4 countries

Bepotastine Besilate Active

Drug Master Files registered with Korea's MFDS (Ministry of Food and Drug Safety), with the holders, manufacturers and registration status of each file.

Active

Browse DMFs

13
All
12
Active
1
Withdrawal
Last Modified
2026-05-20
Data Source
MFDS
First Registration
2017-12-08
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DMF Records Timeline (12 records)
Clear
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.

Visit MFDS
Record Details Preview

Click "View Details" on any record above to expand full details inline.

Manufacturer

Bal Pharma Limited

Identifiers

Registration No.: 20190926-209-J-357
Classification: Appendix 1

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Compiled from official MFDS sources

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