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List of Drug Master Files (KDMF) for Xeljanz Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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$ API Ref.Price (USD/KG) : 16,069Xls
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01 1Engichem Life Sciences Co., Ltd.

02 3Glenmark Life Sciences Limited

03 1Glenmark Pharmaceuticals Limited

04 2H.L.G.Nomics Co., Ltd.

05 1Hunan Jiudian Hongyang Pharmaceutical.Co.,Ltd

06 1Hunan Warrant Chiral Pharmaceutical Co., Ltd.

07 2Hwail Pharmaceutical Co., Ltd. @Changzhou Pharmaceutical Factory

08 1Korea Biochem Pharmaceutical Co., Ltd.

09 1Kyungbo Pharmaceutical Co., Ltd. @Changzhou Pharmaceutical Factory

10 1M/s. Micro Labs Limited

11 2MSN Laboratories Private Limited

12 1Pfizer Asia Manufacturing Pte Ltd

13 1Pfizer Ireland Pharmaceuticals

14 2Phalanx Labs Private Limited

15 1Samjin Pharmaceutical Co., Ltd.

16 1Zhejiang LEPU Pharmaceutical Co., Ltd.

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Tofacitinib citrate

Registrant Name : Hiple Co., Ltd.

Registration Date : 2022-09-16

Registration Number : Su55-7-ND(3)

Manufacturer Name : Glenmark Life Sciences Limit...

Manufacturer Address : Plot No 3109, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gujarat St...

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02

Discovery on Target
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Discovery on Target
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Tofacitinib citrate

Registrant Name : AH Biopharm Co., Ltd.

Registration Date : 2022-07-13

Registration Number : Su424-1-ND

Manufacturer Name : Hunan Jiudian Hongyang Pharm...

Manufacturer Address : Tongguan Circular Economy Industrial base, Wangcheng Economic and Technological Devel...

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03

Discovery on Target
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Tofacitinib citrate

Registrant Name : Otran Pharm Korea Co., Ltd.

Registration Date : 2023-07-05

Registration Number : No. 695-17-ND

Manufacturer Name : Hunan Warrant Chiral Pharmac...

Manufacturer Address : No.139, Tongguan Avenue, Tongguan Circular Economy Industrial Park, Wangcheng Distric...

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04

Discovery on Target
Not Confirmed
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Discovery on Target
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Tofacitinib citrate

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2022-02-14

Registration Number : 2014-24-ND

Manufacturer Name : Hwail Pharmaceutical Co., Lt...

Manufacturer Address : No. 518, East Laodong Road, Changzhou City, Gyeonggi-do, Hwaseong-si, Hyangnam-eup, Y...

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05

Discovery on Target
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Discovery on Target
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Tofacitinib citrate

Registrant Name : Alvogen Korea Co., Ltd.

Registration Date : 2022-12-22

Registration Number : Su522-6-ND

Manufacturer Name : M/s. Micro Labs Limited

Manufacturer Address : Plot No.43-45, KIADB, Bommasandra, Industrial Area, 4th Phase, Anekal Taluk, Bengalur...

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06

Discovery on Target
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Tofacitinib citrate

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2021-12-03

Registration Number : No. 434-35-ND(1)

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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07

Discovery on Target
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Tofacitinib citrate

Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

Registration Date : 2023-09-18

Registration Number : Number 87-38-ND

Manufacturer Name : Pfizer Asia Manufacturing Pt...

Manufacturer Address : 31 Tuas South Avenue 6, 637578, Singapore

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08

Discovery on Target
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Discovery on Target
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Tofacitinib citrate

Registrant Name : Samjin Pharmaceutical Co., Ltd.

Registration Date : 2024-05-29

Registration Number : 1324-2-ND

Manufacturer Name : Samjin Pharmaceutical Co., L...

Manufacturer Address : 156 Osong Life 6-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do

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09

Discovery on Target
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Tofacitinib citrate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2024-02-29

Registration Number : Number 258-17-ND

Manufacturer Name : Zhejiang LEPU Pharmaceutical...

Manufacturer Address : No.29, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, China

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10

Discovery on Target
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Tofacitinib aspartate

Registrant Name : Engichem Life Sciences Co., Ltd.

Registration Date : 2024-02-02

Registration Number : 238-10-ND

Manufacturer Name : Engichem Life Sciences Co., ...

Manufacturer Address : 59 Biovalley-ro, Jecheon-si, Chungcheongbuk-do

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