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  • Professor Andrea M. Armani, University of Southern California
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Galderma Granted Key Manufacturing License Updates for New Biologics Capabilities at Its Center of Excellence

By: via Business Wire
  • The Swedish Medical Products Agency has issued a license update authorizing the future manufacture and bioanalytical testing of Galderma’s proprietary investigational ready-to-use liquid botulinum toxin A, RelabotulinumtoxinA
  • This further establishes Galderma’s Uppsala site as a world-class center of excellence and enhances Galderma’s autonomy in bringing new blockbuster platforms in dermatology to market

Galderma today announced that the Swedish Medical Products Agency (Läkemedelsverket) issued key manufacturing license updates that will allow the company to pursue its ambitious growth and innovation roadmap.

The license updates, issued following the agency’s good manufacturing practices (GMP) inspection of Galderma’s center of excellence in Uppsala, Sweden, enable Galderma to manufacture and perform bioanalytical testing on RelabotulinumtoxinA (QM1114). One of Galderma’s key innovation pipeline assets in Injectable Aesthetics, RelabotulinumtoxinA is a next-generation liquid neuromodulator in Injectable Aesthetics developed using Galderma’s proprietary PEARL™ technology. This technology preserves the molecule’s integrity, resulting in a highly active, complex-free botulinum toxin A.

 

“Our commitment to leading innovation in dermatology is reflected in our high-performance operations. These new license updates granted by the Swedish authorities reflect Galderma’s skills and the capacities we are building to support our rapid growth trajectory. As we work to extend our category leadership globally, these new capabilities will increase Galderma’s autonomy to manufacture and commercialize the next generation of scientifically differentiated innovations in dermatology.”

 

ADRIAN MURPHY

HEAD OF GLOBAL OPERATIONS

GALDERMA

 

Galderma’s center of excellence in Uppsala is one of the company’s four state-of-the-art manufacturing and R&D facilities around the world. Galderma is currently expanding this site in response to growing global demand for science-based premium dermatology solutions. The new facility—scheduled for completion by the end of 2025—will be strategically positioned to cater to the higher demand for injectable aesthetics treatments worldwide and the development of upcoming products. With a modular design that allows for seamless further expansion in the future, this forward-looking approach aligns with both Galderma’s growth strategy and its environment, social and governance (ESG) roadmap.

About RelabotulinumtoxinA (QM1114)

Developed by Galderma, RelabotulinumtoxinA is a highly active, innovative, complex-free and ready-to-use liquid botulinum toxin A with a proprietary strain. Manufactured using a unique state-of-the-art process, it is designed as a liquid. This avoids the need to reconstitute from powder and thus eliminates the variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. RelabotulinumtoxinA is currently being investigated globally, with a view to expanding its neuromodulator portfolio – part of the broadest injectable aesthetics portfolio on the market.

About Galderma

Galderma (SIX: GALD) is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ—the skin—meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com

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