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tofacitinib

Tablets, sustained release (SR) 11 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
EU GMP
Comments
Ref. Xeljanz. Dossier status: Pilot BE completed. Validation stage.
Manufacturer #10844
A pharmaceutical manufacturer operating as an end-to-end CDMO/CMO partner for pharmaceutical products, with vertically integrated capabilities spanning active pharmaceutical ingredients, intermediates, and finished oral solid dosage forms such as tablets and capsules. The company highlights multiple cGMP-inspected manufacturing sites supporting both API and formulation supply, alongside strong in-house development and analytical support for scale-up and commercial production. Its quality system is described as fully GMP-driven across operations, with APIs having undergone EU-GMP inspection/certification and oral solid pharmaceutical products produced under Chinese GMP requirements, reinforced by a mature EHS and compliance culture to ensure reliable global supply.

Manufacturer usually replies in 72 days

tofacitinib

Tablets 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA
Registered in
United States
Manufacturer #38372

Manufacturer founded in 1993, with over 17,000 employees, acts as a CTD dossier owner and manufacturer. It is also a GMP manufacturer with approvals including NMPA (China), US FDA, EU GMP, UK MHRA. Products are sold in 70 countries and regions worldwide As a CTD dossier owner and manufacturer, it holds GMP manufacturer status for both APIs and finished dosage forms. There are 26 finished dosage production lines and 7 narcotic API production lines, certified under national top-ranking GMP standards. This Manufacturer is both CTD dossier owner and manufacturer in key therapeutic areas (steroid hormones, anesthetics etc.), combining R&D, registration and production. It functions as CTD dossier owner and manufacturer across multiple product types.

Manufacturer usually replies in 81 days

tofacitinib

Tablets 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #36474
A pharmaceutical manufacturer producing a wide range of pharmaceutical products including finished dosage forms such as tablets, capsules, syrups, oral solutions and topical patches, along with active pharmaceutical ingredients (APIs), excipients and related materials developed for diverse therapeutic areas. The company operates modern GMP-certified facilities and also provides contract manufacturing (CMO/CDMO) services, supporting research and development as well as production workflows to ensure consistent quality and availability of its pharmaceutical products.

Manufacturer usually replies in 23 days

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Markets of interest JAK (Janus kinase) inhibitor, tofacitinib used to treat moderate to severe rheumatoid arthritis, active psoriatic arthritis and moderate to severe ulcerative colitis. The substance is used alone or with other pharmaceutical products, including methotrexate or certain similar medications for rheumatoid arthritis patients. The medication is prescribed to people with ulcerative colitis who are unable to take or who did not respond to tumor necrosis factor (TNF) inhibitor medications. The drug blocks the body’s immune response by decreasing janus kinase enzymes’ activity, which may stop the inflammatory process in ulcerative colitis. The medication is available for sale in the form of tablets (at concentrations of 5mg, and 10 mg), film coated tablets (at concentration 5mg) or extended release (er) tablets (at concentration of 11 mg), and provided by a wide range of tofacitinib suppliers from various countries including the Y, Y, and Y. Mostly due to the availability of raw materials for the manufacturing process and low labor costs, the leading tofacitinib manufacturers and distributors are based in India and China. Licensing and brand names Tofacitinib was approved by the FDA for the treatment of severely active rheumatoid arthritis in the United States in 2012, in 2017 for the treatment of active psoriatic arthritis, and in 2018, for the treatment of moderately to severely active ulcerative colitis. European Medical Agency (EMA) approved tofacitinib in 2017 for the treatment of severely active rheumatoid arthritis, and in 2018 for the treatment of active psoriatic arthritis and severely active ulcerative colitis. The drug is available for sale as a generic medication. Tofacitinib is marketed in some countries under the trade names Xeljanz. The leading tofacitinib supplier and manufacturer is the Chinese company Beijing THTD Pharmaceutical Technology Co. Ltd. Other manufacturing companies from India, Italy, Argentina, Russia, Turkey and Canada, have also successfully adapted to the demands of the global marketplace and produce a variant of the drug with tofacitinib as an active ingredient. Target supply price The wholesale acquisition cost of the tofacitinib supply of 56 tablets of 5 mg in the EU is about 758 EUR. The retail price in the USA reaches $4,916 for a supply of 60 tablets of 5mg each. The medication wholesale prices and commercial terms can vary depending on the supplier. Information from manufacturers We provide a detailed list of the tofacitinib manufacturers and suppliers that you are looking for. You can also find the dossier status of the drug that you order, and the GMP approvals of the different variants of the medication. The product description of all tofacitinib suppliers contains essential information about the medication, including clinical data, stability zones, and a list of countries where tofacitinib is already registered in. Manufacturers also specify the commercial terms of their offers, such as the market for which the offer is intended, deal type, dossier licensing fee, supply price, payment terms as well as delivery terms. Licensing and brand names Tofacitinib was approved by the FDA for the treatment of severely active rheumatoid arthritis in the United States in 2012, in 2017 for the treatment of active psoriatic arthritis, and in 2018, for the treatment of moderately to severely active ulcerative colitis. European Medical Agency (EMA) approved tofacitinib in 2017 for the treatment of severely active rheumatoid arthritis, and in 2018 for the treatment of active psoriatic arthritis and severely active ulcerative colitis. The drug is available for sale as a generic medication. Tofacitinib is marketed in some countries under the trade names Xeljanz. The leading tofacitinib supplier and manufacturer is the Chinese company Beijing THTD Pharmaceutical Technology Co. Ltd. Other manufacturing companies from India, Italy, Argentina, Russia, Turkey and Canada, have also successfully adapted to the demands of the global marketplace and produce a variant of the drug with tofacitinib as an active ingredient. Target supply price The wholesale acquisition cost of the tofacitinib supply of 56 tablets of 5 mg in the EU is about 758 EUR. The retail price in the USA reaches $4,916 for a supply of 60 tablets of 5mg each. The medication wholesale prices and commercial terms can vary depending on the supplier. Information from manufacturers We provide a detailed list of the tofacitinib manufacturers and suppliers that you are looking for. You can also find the dossier status of the drug that you order, and the GMP approvals of the different variants of the medication. The product description of all tofacitinib suppliers contains essential information about the medication, including clinical data, stability zones, and a list of countries where tofacitinib is already registered in. Manufacturers also specify the commercial terms of their offers, such as the market for which the offer is intended, deal type, dossier licensing fee, supply price, payment terms as well as delivery terms.

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