Dong-A ST Co., Ltd.
KDMF Database (Korea Drug Master File)

Dong-A ST Co., Ltd.

KDMF Database

Korea Drug Master File (KDMF) registrations held with Korea's Ministry of Food and Drug Safety (MFDS).

Active china
  • Total Records 27
  • Latest Modified 2026-05-06
  • Data Source MFDS
  • Last Updated 2026-05-06
Company Overview

Company

Dong-A ST Co., Ltd.

Country

South Korea

Social Profiles

Company Snapshot

Dong-A ST Co., Ltd.

64 Cheonhodaero Dongdaemun-gu, Seoul 130-823

South Korea

donga-pharm.com hjk8833@donga.co.kr View on Map
KDMF Records Timeline (27 records)
2026
15 May
Dapagliflozin formate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Zenji Pharmaceuticals (Suzhou) Ltd.

Registration Number

Su247-19-ND

MFDS Classification

new substance

Initial Registration

2026-05-15

Last Modified

-

Manufacturing Facility

No.122, Xuqing Road, Xuguan Town, Suzhou, Jiangsu, China

Withdrawal Date

-

Final Annual Reporting Year

Country

china

Identifiers

Registration No.: Su247-19-ND

2026
02 Apr
Udenafil Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Porton Pharma Solutions Ltd.

Registration Number

Su247-18-ND

MFDS Classification

new substance

Initial Registration

2026-04-02

Last Modified

-

Manufacturing Facility

1 Fine Chemical Zone, Chongqing Chemical Industry Park, Changshou, Chongqing 401221, China

Withdrawal Date

-

Final Annual Reporting Year

Country

china

Identifiers

Registration No.: Su247-18-ND

2024
20 Jun
hydroquinone Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Eastman Chemical Company

Registration Number

20240620-211-J-1657

MFDS Classification

Appendix 1

Initial Registration

2024-06-20

Last Modified

-

Manufacturing Facility

200 South Wilcox Drive, Kingsport, TN 37660, USA

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

USA

Identifiers

Registration No.: 20240620-211-J-1657

2023
15 Feb
Imiquimod Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Orgapharm

Registration Number

20230215-209-J-1446

MFDS Classification

Appendix 1

Initial Registration

2023-02-15

Last Modified

-

Manufacturing Facility

Zone Industrielle, Rue du Moulin De La Canne, Pithiviers, 45300, France

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

france

Identifiers

Registration No.: 20230215-209-J-1446

2022
01 Sep
Epinaconazole Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Kaneka Corporation Takasago Manufacturing Site

Registration Number

Su247-17-ND

MFDS Classification

new substance

Initial Registration

2022-09-01

Last Modified

2023-04-28

Manufacturing Facility

1-8, Miyamae-machi, Takasago-cho, Takasago, Hyogo 676-8688, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

japan

Identifiers

Registration No.: Su247-17-ND

2022
28 Jan
Tenofovir alafenamide citrate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Mangalam Drug & Organics Ltd. Unit-2

Registration Number

Su247-16-ND

MFDS Classification

new substance

Initial Registration

2022-01-28

Last Modified

2025-06-05

Manufacturing Facility

Plot No. 1203, Phase-III, GIDC, City: Vapi-396 195, Dist. Valsad, Gujarat State, India

Withdrawal Date

-

Final Annual Reporting Year

Country

India

Identifiers

Registration No.: Su247-16-ND

2021
06 Jul
Artemisia leaf 95% ethanol soft extract (20→1)) Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Hunan Jiudian Pharmaceutical.Co.,Ltd.

Registration Number

20210706-9-K-65-09

MFDS Classification

Appendix 1-2

Initial Registration

2021-07-06

Last Modified

-

Manufacturing Facility

Hunan Liuyang Bio-pharmaceutical Industrial Park, Changsha, Hunan, 410329, PR, China

Withdrawal Date

-

Final Annual Reporting Year

2023

Country

china

Identifiers

Registration No.: 20210706-9-K-65-09

2021
09 Apr
Bepotastine besylate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Ube Chemical Factory, Ube Industries, Ltd.

Registration Number

20210409-209-J-702

MFDS Classification

Appendix 1

Initial Registration

2021-04-09

Last Modified

-

Manufacturing Facility

1978-10, Kogushi, Ube, Yamaguchi, Japan

Withdrawal Date

-

Final Annual Reporting Year

2023

Country

japan

Identifiers

Registration No.: 20210409-209-J-702

2021
16 Mar
Limafrost AlphaDex Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Nissan Chemical Corporation, Onoda Plant@Ono Pharmaceutical Co., Ltd., Fujiyama Plant

Registration Number

20210316-209-J-750

MFDS Classification

Appendix 1

Initial Registration

2021-03-16

Last Modified

-

Manufacturing Facility

6903-1, Oaza Onoda, Sanyoonoda-shi, Yamaguchi, Japan@5221-1, Azahigashishimogumi, Kitayama, Fujinomiya-shi, Shizuoka, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

Identifiers

Registration No.: 20210316-209-J-750

2021
04 Mar
Pantoprazole sodium sesquihydrate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Apitoria Pharma Private Limited

Registration Number

20210304-209-J-855

MFDS Classification

Appendix 1

Initial Registration

2021-03-04

Last Modified

2024-01-30

Manufacturing Facility

Unit-I, Sy.No. 379, 385, 386, 388 - 396, Borpatla Village, Hatnoora Mandal, Sangareddy District, Telangana, 502 296 INDIA

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20210304-209-J-855

2020
21 Jul
Johnny Mid Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Juzen Chemical Corporation

Registration Number

20200721-211-J-423

MFDS Classification

Appendix 1

Initial Registration

2020-07-21

Last Modified

2023-12-04

Manufacturing Facility

1-10, Kiba-machi, Toyama-city, Toyama, 930-0806, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

japan

Identifiers

Registration No.: 20200721-211-J-423

2018
04 Dec
Tenofovir disoproxil orotate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Mangalam Drugs and Organics Ltd. (Unit-2)

Registration Number

Su247-15-ND

MFDS Classification

new substance

Initial Registration

2018-12-04

Last Modified

2025-03-17

Manufacturing Facility

Plot No. 1203, Phase-III, GIDC, City : Vapi - 396 195, Dist : Valsad, Gujarat State, India.

Withdrawal Date

-

Final Annual Reporting Year

2023

Country

India

Identifiers

Registration No.: Su247-15-ND

2018
08 Feb
Famotidine Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Gedeon Richter Plc.

Registration Number

20180208-67-B-407-09

MFDS Classification

Appendix 1

Initial Registration

2018-02-08

Last Modified

2023-10-25

Manufacturing Facility

Gyomroi ut 19-21., Budapest, 1103, Hungary

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

Hungary

Identifiers

Registration No.: 20180208-67-B-407-09

2017
05 Apr
Epinaconazole Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

HAMARI PFST, Ltd

Registration Number

Su247-13-ND

MFDS Classification

new substance

Initial Registration

2017-04-05

Last Modified

2021-06-18

Manufacturing Facility

2-4300-18, Hachimampara, Yonezawa, Yamagata, 992-1128, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

japan

Identifiers

Registration No.: Su247-13-ND

2017
05 Apr
Epinaconazole Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Gifu Plant, Oita Works, Sumitomo Chemical Co., Ltd.

Registration Number

Su247-12-ND

MFDS Classification

new substance

Initial Registration

2017-04-05

Last Modified

2021-06-22

Manufacturing Facility

3750, Azajuhachicho, Maki, Ampachicho, Ampachi-Gun, Gifu 503-0125, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

japan

Identifiers

Registration No.: Su247-12-ND

2017
18 Jan
pregabalin Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Mylan Laboratories Limited (Unit-1)

Registration Number

Su247-11-ND

MFDS Classification

new substance

Initial Registration

2017-01-18

Last Modified

2020-05-04

Manufacturing Facility

Survey No. 10, Gaddapotharam Kazipally Industrial AreaSangareddy District – 502319Telangana, India

Withdrawal Date

-

Final Annual Reporting Year

2023

Country

India

Identifiers

Registration No.: Su247-11-ND

2015
29 Oct
Teriparatide acetate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

[Partial Contract Manufacturing (Manufacturer)] Peptide Institute Inc. @ Nagase Diagnostics Co., Ltd. Ohito Pharmaceuticals Plant

Registration Number

Su1290-10-ND

MFDS Classification

new substance

Initial Registration

2015-10-29

Last Modified

2025-12-31

Manufacturing Facility

7-2-9 Saito-Asagi, Ibaraki-shi, Osaka, Japan@632-1 Mifuku, Izunokuni-shi, Shizuoka, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

Identifiers

Registration No.: Su1290-10-ND

2014
10 Apr
gabapentin Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Apitoria Pharma Private Limited Unit-I

Registration Number

20121010-142-I-104-06(1)

MFDS Classification

Appendix 1

Initial Registration

2014-04-10

Last Modified

2024-09-23

Manufacturing Facility

Survey No. 379, 385, 386, 388 to 396 Borpatla Village, Hatnoora Mandal Sangareddy District, Telangana, India, 502296

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20121010-142-I-104-06(1)

2013
12 Sep
Franlucast Luggage Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Fujimoto Chemicals Co., Ltd. Senboku Plant

Registration Number

20130912-171-I-213-05

MFDS Classification

Appendix 1

Initial Registration

2013-09-12

Last Modified

2016-05-19

Manufacturing Facility

1-24, Rinkai-cho, Izumiohtsu-city, Osaka, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

japan

Identifiers

Registration No.: 20130912-171-I-213-05

2013
12 Aug
Naphtopidil Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Asahi Kasei Finechem Co., Ltd. Nobeoka Pharmaceuticals Plant

Registration Number

Su6401-7-ND

MFDS Classification

new substance

Initial Registration

2013-08-12

Last Modified

2026-03-22

Manufacturing Facility

6-2633-7 Asahi-machi, Nobeoka, Miyazaki 882-0847 Japan

Withdrawal Date

-

Final Annual Reporting Year

2026

Country

japan

Identifiers

Registration No.: Su6401-7-ND

2013
08 May
Tosufloxacin tosylate hydrate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Fujifilm Toyama Chemical Co., Ltd. Toyama 1st Factory/

Registration Number

20130418-206-I-208-02(1)

MFDS Classification

Appendix 1

Initial Registration

2013-05-08

Last Modified

2015-06-09

Manufacturing Facility

4-1, Shimo-Okui 2-Chome, Toyama-shi, Toyama, Japan

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

japan

Identifiers

Registration No.: 20130418-206-I-208-02(1)

2013
22 Mar
Donepezil hydrochloride Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Apitoria Pharma Private Limited

Registration Number

20130322-158-I-295-12

MFDS Classification

Appendix 1

Initial Registration

2013-03-22

Last Modified

2021-09-28

Manufacturing Facility

Unit-I, Sy.No. 379, 385, 386, 388 - 396, Borpatla Village, Hatnoora Mandal, Sangareddy District, Telangana, INDIA.

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20130322-158-I-295-12

2012
02 Mar
Levitiracetam Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Apitoria Pharma Private Limited

Registration Number

20120302-183-I-34-01

MFDS Classification

Appendix 1

Initial Registration

2012-03-02

Last Modified

2026-05-06

Manufacturing Facility

Unit-IV, Sy. No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No's 1, 2, 4 to 9, 11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India. PIN: 532 409

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20120302-183-I-34-01

2011
15 Dec
Fluconazole Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Cipla Limited

Registration Number

20050831-74-A-146-03(5)

MFDS Classification

Initial Registration

2011-12-15

Last Modified

2013-05-30

Manufacturing Facility

Plot No. D7, MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, District-Pune, Maharashtra, India (Mumbai Central Mumbai 400 008 India)

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20050831-74-A-146-03(5)

2011
25 Nov
Carvedilol Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Apitoria Pharma Private Limited Unit-II

Registration Number

20070302-60-B-241-17(1)

MFDS Classification

Appendix 1

Initial Registration

2011-11-25

Last Modified

2022-07-05

Manufacturing Facility

Survey No. 10 & 13, IDA, Kazipally, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20070302-60-B-241-17(1)

2011
14 Oct
Sepicsim hydrate Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Orchid Pharma Limited

Registration Number

20050831-26-A-56-03(1)

MFDS Classification

etc

Initial Registration

2011-10-14

Last Modified

2016-08-09

Manufacturing Facility

Plot Nos. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, India

Withdrawal Date

-

Final Annual Reporting Year

2025

Country

India

Identifiers

Registration No.: 20050831-26-A-56-03(1)

2005
25 Nov
Acetyl-carnitine hydrochloride Active

Applicant

Dong-A ST Co., Ltd.

Manufacturer

Biosint SpA

Registration Number

20051125-43-B-216-06

MFDS Classification

Appendix 1

Initial Registration

2005-11-25

Last Modified

2020-07-29

Manufacturing Facility

Via del Murillo, 16/Via Roio 2 - 04013 SERMONETA(LT) ITALY

Withdrawal Date

-

Final Annual Reporting Year

2023

Country

Italy

Identifiers

Registration No.: 20051125-43-B-216-06

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Status Breakdown
27 total
  • Active
Official Source

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

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Country

china

Identifiers

Registration No.: Su247-19-ND

100% Official Data

Compiled from official MFDS & Korean regulatory sources

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Data updated regularly from official sources

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

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