samedan logo

home > news > detailed info

Catalent Announces Commercial Supply Agreement with Aurinia Pharmaceuticals for Newly-Approved LUPKYNIST Softgels


SOMERSET, N.J. – February 18, 2021 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it recently signed a multi-year commercial supply agreement with Aurinia Pharmaceuticals, a biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need, for LUPKYNIS™ (voclosporin), a drug to treat adult patients with lupus nephritis (LN).

LUPKYNIS was approved by the U.S. Food and Drug Administration (FDA) in January 2021 for use in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN, and is the first FDA-approved oral therapy for LN.

Under the terms of the agreement, Catalent will manufacture LUPKYNIS as a softgel dosage form at its pharmaceutical softgel center of excellence in St. Petersburg, Florida.

LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). Approximately 40% of patients with SLE develop LN at some point in their lifetime, and approximately a third have LN when they are diagnosed with SLE. There are approximately 200,000 - 300,000 people with SLE in the United States, making people with LN a significant subset of the total SLE population.

“Catalent has a long track record in bringing novel drugs to market, and has supported over 80% of all prescription pharmaceutical softgel brand launches in the U.S. It has nearly 90 years of experience in the formulation and manufacturing of softgels for both pharmaceutical and consumer health products, which it has drawn upon to jointly develop LUPKYNIS with Aurinia,” commented Dr. Aris Gennadios, President, Softgel and Oral Technologies, Catalent. “We know the benefits that the dosage form offers developers and patients, and look forward to working with Aurinia on the commercial production of this innovative therapeutic option for patients with lupus nephritis going forward, having previously partnered on its development.”

Catalent’s 435,000 square-foot site in St. Petersburg is the company’s primary softgel development and manufacturing facility in North America and has a capacity of 18 billion capsules per year.

Additional information on LUPKYNIS, including the important safety information for the product, can be found at

phone +1 888 765 8846
email 14 Schoolhouse Road, Somerset 08873 NJ , USA
Print this page
Send to a friend
News and Press Releases

New laboratory and regulatory services for biotech customers

USA/Germany, September 21, 2020. Gerresheimer adds essential laboratory and regulatory services to its broad portfolio of products, solutions and services for biotech companies. Specialized laboratory technicians and an experienced team of further specialists offer these services in the two innovation and technology centers in Bünde (Germany) and Vineland (New Jersey/USA). Gx Biological Solutions offers full service for biotech companies regarding product development of primary packaging and drug delivery solutions, material and functional testing as well as comprehensive regulatory support. The partnership with Gerresheimer shortens the time to market for pharmaceutical companies, minimizes risks and saves resources.
More info >>

White Papers

Exploring Protein Stability by nanoDSF

NanoTemper Technologies GmbH

nanoDSF determines thermal and chemical protein stability with ultra-high resolution and with unmatched reproducibility. The detection of the intrinsic tryptophan and tyrosin fluorescence enables measurements at close-to-native conditions in any buffer, even in the presence of detergents. nanoDSF is applied in antibody engineering, membrane protein research, formulation and quality control.
More info >>

Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement