Docetaxel
KDMF Registration Details

Docetaxel

Korea DMF Database

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

Active 6 countries
  • Total Records 13
  • Last Modified 2026-01-23
  • Data Source MFDS
  • Last Updated 2026-01-23
DMF Records Timeline (13 records)
2021
31 Mar
Borak Co., Ltd. Active

Product

Docetaxel trihydrate

Registration Number

20210331-210-J-917

Initial Registration

2021-03-31

Last Modified

2024-12-30

MFDS Classification

Appendix 1

Country

korea

Manufacturer

Borak Co., Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2022

Manufacturing Facility

720-37, Chorok-ro, Yanggam-myeon, Hwaseong-si, Gyeonggi-do

2024
14 Oct
Hiple Co., Ltd. Active

Product

Docetaxel trihydrate

Registration Number

20200723-210-J-699(A)

Initial Registration

2024-10-14

Last Modified

-

MFDS Classification

Appendix 1

Country

china

Manufacturer

Qilu Pharmaceutical Co., Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year:

Manufacturing Facility

No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, 250100, PR China

2022
24 May
Hiple Co., Ltd. Active

Product

Docetaxel trihydrate

Registration Number

20220524-210-J-1304

Initial Registration

2022-05-24

Last Modified

2025-03-20

MFDS Classification

Appendix 1

Country

taiwan

Manufacturer

ScinoPharm Taiwan, Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year:

Manufacturing Facility

No. 1, Nan-ke 8th Road, Shan-Hua, Tainan 741014, Taiwan

2026
14 Apr
Kangil Chemipharm Co., Ltd. Active

Product

Docetaxel trihydrate

Registration Number

20250812-210-J-1965(1)

Initial Registration

2026-04-14

Last Modified

-

MFDS Classification

Appendix 1

Country

china

Manufacturer

Shandong Anxin Pharmaceutical Co., Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year:

Manufacturing Facility

Circular Economy Demonstration Park, Laoling County, Dezhou City 253600, Shandong Province, China

2022
03 Aug
Kangil Chemipharm Co., Ltd. Active

Product

Docetaxel

Registration Number

20220517-210-J-1300(1)

Initial Registration

2022-08-03

Last Modified

2025-03-11

MFDS Classification

Appendix 1

Country

china

Manufacturer

Qilu Pharmaceutical Co. Ltd

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2023

Manufacturing Facility

No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, PRChina Post code: 250100

2020
06 Nov
Masung LS Co., Ltd. Active

Product

Docetaxel hydrate

Registration Number

20201106-210-J-765

Initial Registration

2020-11-06

Last Modified

2022-02-04

MFDS Classification

Appendix 1

Country

India

Manufacturer

Mac-Chem Products (India) Pvt.Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2025

Manufacturing Facility

N-211/2/10, Tarapur, MIDC, Boisar, Dist. Palghar, 401506, India

2021
13 Jan
Myeongmun Pharmaceutical Co., Ltd. Active

Product

Docetaxel

Registration Number

20210113-210-J-821

Initial Registration

2021-01-13

Last Modified

-

MFDS Classification

Appendix 1

Country

India

Manufacturer

Intas Pharmaceuticals Limited

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2022

Manufacturing Facility

Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacharwadi, Taluka–Sanand 382210, District - Ahmedabad, State India

2020
08 Oct
Myeongmun Pharmaceutical Co., Ltd. Active

Product

Docetaxel

Registration Number

20201008-210-J-763

Initial Registration

2020-10-08

Last Modified

2026-01-23

MFDS Classification

Appendix 1

Country

taiwan

Manufacturer

Scinopharm Taiwan, Ltd

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2022

Manufacturing Facility

No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Tainan

2020
23 Jul
Otran Korea Co., Ltd. Active

Product

Docetaxel hydrate

Registration Number

20200723-210-J-699

Initial Registration

2020-07-23

Last Modified

2025-04-22

MFDS Classification

Appendix 1

Country

china

Manufacturer

Qilu Pharmaceutical Co., Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2024

Manufacturing Facility

No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, 250100, PR China

2025
12 Aug
Sampung Pharmachem Co., Ltd. Active

Product

Docetaxel trihydrate

Registration Number

20250812-210-J-1965

Initial Registration

2025-08-12

Last Modified

-

MFDS Classification

Appendix 1

Country

china

Manufacturer

Shandong Anxin Pharmaceutical Co., Ltd.

Identifiers

Withdrawal Date: -
Final Annual Reporting Year:

Manufacturing Facility

Circular Economy Demonstration Park, Laoling County, Dezhou City 253600, Shandong Province, China

2020
21 Apr
Sampung Pharmachem Co., Ltd. Active

Product

Docetaxel

Registration Number

20200421-210-J-608

Initial Registration

2020-04-21

Last Modified

-

MFDS Classification

Appendix 1

Country

Canada

Manufacturer

Phyton Biotech LLC

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2024

Manufacturing Facility

1527 Cliveden Avenue, Delta, British Columbia, V3M6P7, Canada

2022
17 May
Samyang Biopharm Co., Ltd. Active

Product

Docetaxel

Registration Number

20220517-210-J-1300

Initial Registration

2022-05-17

Last Modified

2025-12-16

MFDS Classification

Appendix 1

Country

china

Manufacturer

Qilu Pharmaceutical Co. Ltd

Identifiers

Withdrawal Date: -
Final Annual Reporting Year: 2023

Manufacturing Facility

No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, PRChina Post code: 250100

2023
07 Jun
Sanofi-Aventis Korea Co., Ltd. Active

Product

Docetaxel trihydrate

Registration Number

20230607-210-J-1506

Initial Registration

2023-06-07

Last Modified

2025-03-14

MFDS Classification

Appendix 1

Country

france

Manufacturer

Sanofi Winthrop Industrie

Identifiers

Withdrawal Date: -
Final Annual Reporting Year:

Manufacturing Facility

9, quai Jules Guesde, Vitry-sur-Seine, 94403, France

Related Databases
Status Breakdown
13 total
  • Active
Official Source

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

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