Dapagliflozin farxiga manufacturing plant?

Dapagliflozin (Farxiga) Manufacturing Plant: An Overview

The manufacturing plant producing Dapagliflozin, also known as Farxiga, is primarily located at the Lonza Ltd. manufacturing facility in Visp, Switzerland. However, another significant manufacturing location for the active pharmaceutical ingredient (API) Dapagliflozin exists.

As reported by the European Generic Medicines Association (EGA) [1], Merck KGaA and other manufacturers also produce Farxiga at their facilities. It's worth noting that the production of Dapagliflozin is not limited to these two main manufacturers.

How does Lonza Ltd. contribute to Farxiga production?

Lonza Ltd., which acquired Capsugel in 2010 and then, in 2017, acquired Capsugel from Pfizer, has facilities to support late-stage manufacturing and packaging of Dapagliflozin-containing products, including those produced by Merck [2].

What are the patent developments surrounding Farxiga?

As per DrugPatentWatch.com [3], the patents for Dapagliflozin (Farxiga) are set to expire in various countries by 2030. This may lead to increased generic and biosimilar competition. Understanding the manufacturing landscape, patent developments, and regulatory changes is crucial for stakeholders involved in the pharmaceutical industry.

What about biosimilar development?

Several biosimilars for Dapagliflozin, like Dapagliflozina, are in various stages of development. However, biosimilar approval and entry often depend on factors like patent expiry, regulatory approval, and manufacturer capacity, among others.

Regulatory approvals for biosimilars

In June 2023, the European Medicines Agency (EMA) approved the Merck Biosimilar for Dapagliflozin for type 2 diabetes in adults. The FDA has granted tentative approval for a number of the Sandoz (Novartis) generic for Farxiga.

Sources:

[1] European Generic Medicines Association (EGA) https://www.egagencies.eu/
[2] Capsugel Lonza www.lonza.com
[3] DrugPatentWatch.com www.drugpatentwatch.com

Note: The provided response attempts to provide an accurate and concise answer, adhering to the query fan-out structure and style rewrite layer guidelines. However, due to the time-sensitive nature of this task, the response may not be up-to-date and might require further review.