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Minakem Generic APIs Minakem Generic APIs

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List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Kukjeon Pharmaceutical to the Review Authority in Korea.

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01 Altioctate Tromethamine salt (1)

02 Amlodipine adipate (1)

03 Atorvastatin Calcium (1)

04 Celecoxib (1)

05 Choline alfoscerate (2)

06 Cinacalcet hydrochloride (1)

07 Dapagliflozin citrate (1)

08 Eperisone hydrochloride (1)

09 Epinastine hydrochloride (1)

10 Escitalopram oxalate (1)

11 Fimasartantromethamine saline hydrate (1)

12 Guayacol (1)

13 Isotretinoin (1)

14 Itopride hydrochloride (1)

15 Loxoprofen sodium hydrate (1)

16 Napamostat Mesylate (1)

17 Nizatidine (1)

18 Phendimetrazine Tartrate (1)

19 Pyrazinamide (1)

20 Solifenacin succinate (1)

21 Tianeptine Sodium (1)

22 doxycycline monohydrate (1)

23 spherical adsorption bomb (1)

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01 HK Innoen Co., Ltd. (1)

02 Kookjeon Pharmaceutical Co., Ltd. (23)

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01 Gukjeon Pharmaceutical Co., Ltd.@Yantai Valiant pharmaceutical Co., Ltd.@Anhui Heryi Pharmaceutical Co., Ltd (1)

02 Gukjeon Pharmaceutical Co., Ltd.@[Manufacturer of starting material 'loxopropenoic acid'] Liaoning Medya Pharmaceutical Co.,Ltd.@Dijia Pharmaceutical Group Co., Ltd (1)

03 Gukjeon Pharmaceutical Co., Ltd.@[Manufacturer] Suzhou Homesun Pharmaceutical Co., Ltd (1)

04 Gukjeon Pharmaceutical Co., Ltd.@[Starting material (amlodipine) manufacturing site]Changzhou Ruiming Pharmaceutical Co.,Ltd. (1)

05 Gukjeon Pharmaceutical Co., Ltd.@[Zhebang Pharmaceutical Co., Ltd.] Zhejiang Zhebang Pharmaceutical Co.,Ltd. (1)

06 Gukjeon Pharmaceutical Co.,Ltd@[Manufacturer of crude product] Jiangsu ToHope Pharmaceutical Co.,Ltd@[Manufacturer of starting material] Zhejiang Changming Pharmaceutical Co., Ltd (1)

07 Guobang Pharmaceutical Co., Ltd.@[Act 2] Zhejiang Guobang Pharmaceutical Co., Ltd (1)

08 Hubei Haosun Pharmaceutical Co., Ltd.@Anhui Heryi Pharmaceutical Co., Ltd. (1)

09 Kookjeon Pharmaceutical Co., Ltd. (4)

10 Kookjeon Pharmaceutical Co., Ltd. @[Jopum Manufacturer] Reine Lifescience (1)

11 Kookjeon Pharmaceutical Co., Ltd. @[Starting Material Manufacturing Site] Lee Pharma Limited (1)

12 Kookjeon Pharmaceutical Co., Ltd.@Calyx Chemicals & Pharmaceuticals Ltd (1)

13 Kookjeon Pharmaceutical Co., Ltd.@Synergene Active Ingredients Pvt. Ltd. (1)

14 Kukjeon Pharmaceutical Co., Ltd. @[Manufacturer of Jopum] Jiangsu Nhwa Pharmaceutical Co., Ltd. (1)

15 Kukjeon Pharmaceutical Co., Ltd.@[Manufacturer of Jopum] Vasudha Pharma Chem Limited(Unit-III)@Anhui Heryi Pharmaceutical Co., Ltd (1)

16 Kukjeon Pharmaceutical Co., Ltd.@[Starting Material Manufacturer]Aurore Pharmaceuticals Private Limited (Unit-1) (1)

17 Kukjeon Pharmaceutical Co., Ltd.@[Starting material (doxycycline hyclate) Yancheng Suhai Pharmaceutical Co.,Ltd (1)

18 Suzhou Fushilai Pharmaceutical Co., Ltd.@[Jopum Manufacturer①] Suzhou Fushilai Pharmaceutical Co.,Ltd@[Jopum Manufacturer ②] Zhongshan Belling Biotechnology Co.,Ltd (1)

19 [1st law crude product manufacturer ③] Dong Zhi Tang Pharmaceutical (Anhui) Co., Ltd.@[law 1 crude product manufacturer ①] Zhongshan Belling Biotechnology Co.,Ltd@[3rd law crude product manufacturer ①] Zhongshan Belling Biotechnology Co.,Ltd@[3rd method p (1)

20 [Guobang Pharmaceutical Co., Ltd.]Zhejiang Guobang Pharmaceutical Co., Ltd.@[Guobang Pharmaceutical Co., Ltd.@[Guobang Pharmaceutical Co., Ltd.①]Zhejiang Warrant Pharmaceutical Co., Ltd (1)

21 [Subdivided packaging (subdivided manufacturer)]_x000D_ Kukjeon Pharmaceutical Co., Ltd.@[Subdivided portion manufactured (manufacturer)]_x000D_ Hanseochem Co., Ltd. (1)

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01 South Korea (24)

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Kookjeon Pharmaceutical Co., Ltd.
2017-05-29
20170529-166-I-533-10
Gukjeon Pharmaceutical Co...
South Korea
8 Balangongdan-ro, Hyangn...
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HK Innoen Co., Ltd.
2017-04-07
20170407-130-H-331-46
Gukjeon Pharmaceutical Co...
South Korea
8 Balangongdan-ro, Hyangn...
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Kookjeon Pharmaceutical Co., Ltd.
2017-03-17
20170317-132-H-325-42
Kookjeon Pharmaceutical C...
South Korea
8 Balangongdan-ro, Hyangn...
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Kookjeon Pharmaceutical Co., Ltd.
2018-06-20
20180620-209-J-114
Gukjeon Pharmaceutical Co...
South Korea
8@60 Balangongdan-ro, Hya...
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Kookjeon Pharmaceutical Co., Ltd.
2014-11-19
20141119-168-I-449-12
[1st law crude product ma...
South Korea
[1st Law Torch Manufactur...
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Kookjeon Pharmaceutical Co., Ltd.
2015-06-25
20150625-168-I-473-14
Suzhou Fushilai Pharmaceu...
South Korea
8 Balangongdan-ro, Hyangn...
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Kookjeon Pharmaceutical Co., Ltd.
2017-04-07
2520-21-ND
Guobang Pharmaceutical Co...
South Korea
8@No.6 , Balangongdan-ro ...
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Kookjeon Pharmaceutical Co., Ltd.
2023-09-21
2520-45-ND
Kookjeon Pharmaceutical C...
South Korea
8 Balangongdan-ro, Hyangn...
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Kookjeon Pharmaceutical Co., Ltd.
2017-10-10
20171010-101-F-86-03
Kukjeon Pharmaceutical Co...
South Korea
8 Balangongdan-ro, Hyangn...
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Kookjeon Pharmaceutical Co., Ltd.
2014-07-18
20140718-46-C-332-10
Gukjeon Pharmaceutical Co...
South Korea
8@No. Balangongdan-ro, Hy...
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