Clopidogrel Bisulfate Withdrawn - KDMF Registration Details

Korea DMF Database
Indiakorea
Clopidogrel Bisulfate Withdrawn

Clopidogrel Bisulfate Withdrawn

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

Withdrawal
Last Modified
2026-02-09
Data Source
MFDS
First Registration
2011-05-16
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DMF Records Timeline (6 records)
Clear
2011
12 Aug
Daewoong Pharmaceutical Co., Ltd. Withdrawal

Product

Clopidogrel sulfate

Registration Number

20110225-129-H-88-15(5)

Initial Registration

2011-08-12

Last Modified

2026-02-09

MFDS Classification

Appendix 1

Country

India

Manufacturer

Dr. Reddy's Laboratories Ltd.

Identifiers

Withdrawal Date: 2026-02-09
Final Annual Reporting Year: 2025

Manufacturing Facility

CTO-Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

2017
08 Dec
IMCD Korea Co., Ltd. Withdrawal

Product

Clopidogrel sulfate

Registration Number

20110225-129-H-88-15(12)

Initial Registration

2017-12-08

Last Modified

2025-11-07

MFDS Classification

Appendix 1

Country

India

Manufacturer

Dr. Reddy's Laboratories Limited

Identifiers

Withdrawal Date: 2025-11-07
Final Annual Reporting Year: 2025

Manufacturing Facility

CTO-Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

2011
16 May
Kyungdong Pharmaceutical Co., Ltd. Withdrawal

Product

Clopidogrel sulfate

Registration Number

20110516-129-H-167-17

Initial Registration

2011-05-16

Last Modified

2024-02-14

MFDS Classification

Appendix 1

Country

korea

Manufacturer

Kyungdong Pharmaceutical Co., Ltd.

Identifiers

Withdrawal Date: 2024-02-14
Final Annual Reporting Year: 2014

Manufacturing Facility

224-3, Jeyakdanji-ro, Yanggam-myeon, Hwaseong-si, Gyeonggi-do

2013
04 Jul
Seongwoo Chemical Co., Ltd. Withdrawal

Product

Clopidogrel sulfate

Registration Number

20130704-129-H-223-32

Initial Registration

2013-07-04

Last Modified

2023-07-13

MFDS Classification

Appendix 1

Country

India

Manufacturer

Ipca Laboratories Limited

Identifiers

Withdrawal Date: 2023-07-13
Final Annual Reporting Year: 2022

Manufacturing Facility

PO Sejavta Dist. Ratlam (MP) PIN. 457 002, India

2011
15 Sep
ST Pharm Co., Ltd. Withdrawal

Product

Clopidogrel sulfate

Registration Number

20110915-129-H-182-26

Initial Registration

2011-09-15

Last Modified

2024-02-16

MFDS Classification

Appendix 1

Manufacturer

ST Pharm Co., Ltd. @ [Manufacturer of Starting Material (Clopidogrel Camposulfonic Acid) ①] Zhejiang Liaoyuan Pharmaceutical Co., Ltd.

Identifiers

Withdrawal Date: 2024-02-16
Final Annual Reporting Year: 2023

Manufacturing Facility

231, Hyeopnyeop-ro, Siheung-si, Gyeonggi-do @ Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone, Duqiao town, Linhai City, Zhejiang Province, 317016, China

2022
19 Sep
Teragen Etex Co., Ltd. Withdrawal

Product

Clopidogrel hydrogen sulfate

Registration Number

20210715-129-H-390-56(3)

Initial Registration

2022-09-19

Last Modified

2026-01-26

MFDS Classification

Appendix 1

Country

India

Manufacturer

Dr. Reddy's Laboratories Ltd.

Identifiers

Withdrawal Date: 2026-01-26
Final Annual Reporting Year:

Manufacturing Facility

CTO-Unit-V, Peddadevulapally Village, Tripuraram Mandal, Nalgonda District, Telangana - 508207, India

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Status Breakdown
6 total
  • Withdrawal
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

Dr. Reddy's Laboratories Ltd.

Identifiers

Registration No.: 20110225-129-H-88-15(5)
Classification: Appendix 1

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