GALD GALDERMA GROUP AG

Galderma Granted Key Manufacturing License Updates for New Biologics Capabilities at Its Center of Excellence

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:

EN
19/06/2024

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on GALDERMA GROUP AG

 PRESS RELEASE

AMWC 2025: Galderma Pushes the Innovation Frontier With Updates From I...

ZUG, Switzerland--(BUSINESS WIRE)-- Galderma (SWX:GALD) will showcase a strong presence at the 23rd Aesthetic & Anti-Aging Medicine World Congress (AMWC) in Monaco from March 27-29, 2025, with two symposia, four Masterclass sessions, 11 research e-posters, and an experiential Galderma lounge alongside its interactive booth (O2, Hall Ravel) featuring five Meet-the-Expert sessions. This extensive program highlights the breadth of Galderma’s leading Injectable Aesthetics portfolio, designed to address the present and future needs of patients and healthcare professionals alike. This press release ...

 PRESS RELEASE

Galderma Delivers 2024 Record Net Sales of 4.410 Billion USD, up 9.3% ...

ZUG, Switzerland--(BUSINESS WIRE)-- Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its financial results for the full year 2024, delivering strong results for another consecutive year while making significant progress with its blockbuster platforms and future growth drivers. Record net sales: Achieved 4,410 million USD in net sales, up 9.3% year-on-year on a constant currency basis1, with volume-based growth fueled by focused execution and differentiated innovation Broad-based growth: Continued performance across all product categories with constan...

 PRESS RELEASE

AAD 2025: Galderma to Present Extensive Updates From Across Its Dermat...

ZUG, Switzerland--(BUSINESS WIRE)-- Galderma will present updates from across its broad dermatology portfolio at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place from March 7-11, 2025 in Orlando, Florida. The company will present 22 e-posters – including two oral presentations – with updates on a number of its innovative products, including Nemluvio, Sculptra, Restylane and Relfydess. These presentations combined reinforce the strength of Galderma’s growth journey, its status as the pure-play category leader in dermatology, and its innovative pipeline. “We’re bring...

 PRESS RELEASE

Galderma’s Nemluvio® (Nemolizumab) Granted Marketing Authorization in ...

ZUG, Switzerland--(BUSINESS WIRE)-- Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumab’s subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at leas...

 PRESS RELEASE

Galderma’s Nemluvio® (Nemolizumab) Approved in the European Union for ...

ZUG, Switzerland--(BUSINESS WIRE)-- Galderma (SWX:GALD) today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.11 This press release features multimedia. View the full release...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch