Tech Sheet on Tofacitinib Citrate
Tofacitinib Citrate (Xeljanz) is an oral, small molecule drug used to treat adults with moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis, and moderate to severe ulcerative colitis. Tofacitinib works by blocking the body’s production of enzymes called Janus kinases (JAKs). Tofacitinib citrate is the first oral JAK inhibitor approved for use in chronic ulcerative colitis
The global drug sales of Tofacitinib (Xeljanz®) stood at 2.6 billion USD in 2022 and recorded a historical growth (CAGR) of 22% between 2017 to 2022. In addition, before losing patent protection in 2026, it is expected that Tofacitinib will witness peak sales at $2.8 billion in 2025.
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- Crystalline polymorphic form
- Customized particle size distribution (PSD), which plays a vital role in the formulation development.
- Our process involves efficient chemical transformations that offer a distinctive advantage concerning quality and manufacturability.
We manufacture Tofacitinib citrate API at our cGMP API manufacturing facility, successfully inspected by international regulatory authorities - USFDA, KFDA, WHO-GMP, Russian federation, and ANVISA (document-based inspection completed and certificate is available).
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