01 1Enzychem Life Sciences Co., Ltd. @Kekule Pharma Limited
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.
01 1AH Biopharm Co., Ltd.
02 2Aging Life Science Co., Ltd.
03 1Alvogen Korea Co., Ltd.
04 1Engichem Life Sciences Co., Ltd.
05 2H.L.G.Nomics Co., Ltd.
06 1Hiple Co., Ltd.
07 2Hwail Pharmaceutical Co., Ltd.
08 2Klasia Co., Ltd.
09 1Korea Biochem Pharmaceutical Co., Ltd.
10 2Korea Pfizer Pharmaceutical Co., Ltd.
11 1Kukjeon Pharmaceutical Co., Ltd.
12 1Kyungbo Pharmaceutical Co., Ltd.
13 1M-Peak Korea Co., Ltd.
14 1Otran Pharm Korea Co., Ltd.
15 1Pharmapia Co., Ltd.
16 1SG Biochem Co., Ltd.
17 1Samjin Pharmaceutical Co., Ltd.
01 3Tofacitinib aspartate
02 16Tofacitinib citrate
03 2Topacitinib
04 1Topacitinib hydrate
01 3China
02 9India
03 7South Korea
04 2U.S.A
05 1Blank
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...
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...
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...
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, P...
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...
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), ...
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
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 Osongsaengmyeong 6-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-02-29
Registration Number : Su258-17-ND
Manufacturer Name : Zhejiang LEPU Pharmaceutical...
Manufacturer Address : No.29, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, China
Registrant Name : Engichem Life Sciences Co., Ltd.
Registration Date : 2024-02-02
Registration Number : 238-10-ND
Manufacturer Name : Enzychem Life Sciences Co., ...
Manufacturer Address : 59 Biovalley-ro, Jecheon-si, Chungcheongbuk-do @Sy.No . 180/1 to 15, MIA, Kazipally, ...
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A Tofacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tofacitinib, including repackagers and relabelers. The FDA regulates Tofacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tofacitinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Tofacitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tofacitinib supplier is an individual or a company that provides Tofacitinib active pharmaceutical ingredient (API) or Tofacitinib finished formulations upon request. The Tofacitinib suppliers may include Tofacitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Tofacitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tofacitinib Drug Master File in Korea (Tofacitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tofacitinib. The MFDS reviews the Tofacitinib KDMF as part of the drug registration process and uses the information provided in the Tofacitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tofacitinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tofacitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tofacitinib suppliers with KDMF on PharmaCompass.
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