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Where is tagrisso manufactured?

See the DrugPatentWatch profile for tagrisso

Tagrisso (osimertinib) is produced by AstraZeneca, the company that holds the commercial rights to the drug. The exact, day‑to‑day manufacturing site details are kept under the usual regulatory confidentiality that applies to pharmaceutical manufacturing, but the public information that is available points to a few key locations in the world’s major production hubs.

Region Typical Manufacturing Site Notes
United Kingdom Cambridge, UK (AstraZeneca’s main small‑molecule manufacturing facility) This site is a GMP‑certified plant that handles the synthesis of many of AstraZeneca’s oncology APIs, including osimertinib.
United States St. Charles, Missouri (AstraZeneca’s U.S. oncology production hub) The St. Charles facility is a GMP‑approved plant that produces a range of oncology drugs for the U.S. market. It is one of the primary sites for Tagrisso’s U.S. supply.
Other Global Locations Multiple sites across the U.S., Europe, and Asia AstraZeneca operates a network of GMP‑certified plants for global distribution. Tagrisso is manufactured at several sites to meet demand and to support regional supply chain resilience.

How the manufacturing process works

  1. API synthesis – The active ingredient, osimertinib, is produced through a multi‑step chemical synthesis that starts with simple precursors and involves a series of reactions, purifications, and crystallizations.
  2. Quality control – At each step, the intermediate product is tested against strict analytical methods (HPLC, mass spectrometry, etc.) to ensure purity, potency, and consistency.
  3. Formulation – The purified API is blended with excipients (filler, binder, lubricant) to produce the final tablet formulation. The tablets are then compressed, coated, and packaged.
  4. GMP compliance – All stages take place in facilities that are fully compliant with Good Manufacturing Practice (GMP) standards set by the U.S. FDA, the European Medicines Agency (EMA), and other regulatory bodies.

Why multiple sites are used

  • Supply chain resilience – Having several manufacturing plants allows AstraZeneca to keep Tagrisso available even if one site faces a temporary shutdown (maintenance, raw‑material shortage, natural disaster, etc.).
  • Regulatory and market access – Producing the drug in the U.S. and the EU (and in other regions) helps meet local regulatory requirements and speeds up product availability.
  • Demand forecasting – Tagrisso is a high‑demand oncology drug, and distributed production ensures that the global patient population can receive treatment without significant delays.

Bottom line

  • Tagrisso is manufactured by AstraZeneca.
  • Primary manufacturing hubs are the Cambridge, UK plant and the St. Charles, MO, U.S. plant, with additional GMP‑certified sites worldwide to support global supply.
  • Exact, day‑to‑day location details are not publicly disclosed beyond these general regions, but the production follows the same rigorous GMP standards across all facilities.

If you need the most current, specific plant information (for example, for regulatory or supply‑chain inquiries), the best route is to contact AstraZeneca’s customer support or the regulatory authority in your jurisdiction.



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