CROMA-PHARMA-GMBH
8.7.2020 15:02:07 CEST | Business Wire | Press release
On July the 8th , Croma-Pharma GmbH (Croma) has stated that the company submitted the drug file of its botulinum toxin product to the German authority BfArM. The filing of the dossier stands for the next essential step towards Croma’s complete aesthetic portfolio in Europe, which already comprises of a comprehensive HA filler range, threads, PRP and skincare products.
Croma has licensed the product from the Korean toxin producer Hugel Inc. for Europe and established a joint venture company in 2018 with Hugel, Inc., in order to develop and commercialize Croma’s HA filler products together with Hugel’s botulinum toxin product in the US, Canada, Australia and New Zealand.
The filing to BfArM marks the first milestone in Croma’s approach to a European wide regulatory approval.
“We are pleased to announce that our toxin has finally been submitted – since quite some time hence, a European company will launch a botulinum toxin, which makes us both, happy and proud. Combining our present product and service offering with the last “missing link” will definitely boost our business and will have a feelable impact not only on our marketing and sales approach, but for sure also on our corporate culture.”, CEO Andreas Prinz points out in a first statement.
Croma’s botulinum toxin submission in Europe is based on 2 completed randomized, placebo-controlled Phase III pivotal trials (BLESS I and II) that enrolled a total of 917 subjects in Europe and the US. A third confirmatory pivotal trial to support the US submission (BLESS III) is currently ongoing in sites in Europe and the US and has completed its interim analysis after all 355 patients completed their visits for the primary endpoint.
About Croma-Pharma GmbH
Founded in 1976, Croma-Pharma GmbH (Croma) is an Austrian family-owned company that specializes in the industrial production of hyaluronic acid syringes for the fields of medical aesthetics, ophthalmology and orthopaedics. Croma currently runs 12 international sales companies and distributes its products in more than 70 countries. Within its global sales network, Croma focuses with own branded products on minimally invasive aesthetic medicine. Besides a broad range of HA fillers from the own production site, Croma markets PDO lifting threads, a Platelet Rich Plasma (PRP) system and a personalized skincare technology in its core strategic markets.
About Hugel, Inc:
Established in Korea in 2001, Hugel is a global leader in medical aesthetics providing botulinum toxin formulation BOTULAX / LETYBO, HA filler The CHAEUM / DERMALAX, and derma cosmetic WELLAGE / PR4 brands. Dedicated to provide proven, high quality medical aesthetic solutions that satisfy both consumers’ and practitioners’ needs, Hugel is leading Korean market for both botulinum toxin and HA filler products and is distributing its products to over 40 countries. Visit: www.hugel.co.kr
View source version on businesswire.com: https://www.businesswire.com/news/home/20200708005060/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
NIQ (NYSE: NIQ) Unveils Six New AI-Powered Capabilities at C360, Executing on Its Vision for Agentic Commerce9.6.2026 21:00:00 CEST | Press release
New capabilities help organizations operationalize trusted market intelligence across enterprise AI environments and workflows, while preparing for the future of agentic commerce NielsenIQ (NYSE: NIQ) today unveiled six new AI-powered capabilities at C360, the company's flagship client and industry event, marking a major milestone in the execution of NIQ’s AI strategy. Thenew capabilities help brands, retailers, and other organizations operationalize trusted market intelligence across enterprise workflows, AI environments, and the emerging world of agentic commerce. NIQ’s AI value creation strategy is built on two foundational principles: Delivering The Full View™: Combining the industry’s broadest and deepest datasets, advanced AI models, and rich content to help organizations unlock actionable insights and drive AI innovation at scale. Enabling AI-Powered Capabilities: Delivering trusted intelligence and proprietary IP through NIQ’s advanced AI applications, assistants, and agents em
H55 Delivers Certification-Grade Propulsion Battery Modules to Pratt & Whitney Canada, Supporting Demonstration of Hybrid-Electric Aircraft Technology9.6.2026 17:31:00 CEST | Press release
Production-conforming systems manufactured in a regulator-approved facility mark H55’s transition from technology development to commercialization of certification-grade energy storage solutions for hybrid-electric aviation. H55 today announced the delivery of certification-grade propulsion battery modules to Pratt & Whitney Canada in support of the RTX Hybrid-Electric Flight Demonstrator — a milestone that further validates H55’s transition from technology development to industrial-scale execution and represents an important step in the commercialization of the company’s certification-grade energy storage technologies for hybrid-electric aerospace applications. Pratt & Whitney is an RTX business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609825006/en/ H55 Adagio Battery Modules in Pratt & Whitney Canada Hangar ©RTX The delivery represents more than hardware integration. It demonstrates H55’s ability to manufacture p
New Polymorph of Indomethacin Discovered9.6.2026 17:00:00 CEST | Press release
- Joint Research Involving Rigaku Published in Crystal Growth & Design - Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; “Rigaku”), announced that the results of a joint research project conducted with Shionogi & Co., Ltd., JEOL Ltd., and Meiji Pharmaceutical University have been published in Crystal Growth & Design, a world-renowned international journal in the field of crystallography. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609347405/en/ Cover of the June 2026 issue of Crystal Growth & Design, featuring this research. This research uncovered a previously unknown polymorph (κ-form) of indomethacin, a widely used pain relief and anti-inflammatory drug. The research team also conducted structural analysis and characterization of the newly identified crystal form. Although indomethacin has
SLB Collaborates with Qualcomm on Edge AI Solutions for Energy Operations9.6.2026 16:28:00 CEST | Press release
Collaboration combines edge computing and energy workflows to support real-time operational decision-making Global energy technology company SLB (NYSE: SLB) today announced a memorandum of understanding with Qualcomm Technologies, Inc. to enable edge AI solutions for the energy industry, supporting real-time operational decision-making across wells, facilities and production systems. The collaboration combines Qualcomm Technologies’ low-power edge computing and AI processing capabilities, with SLB’s Agora™ edge AI and IoT solutions developed for remote and operationally complex environments. “Together, SLB and Qualcomm Technologies aim to help operators apply AI more effectively across energy infrastructure,” said Rakesh Jaggi, president, Digital, SLB. “Many energy operations rely on real-time decision-making in remote environments where connectivity and responsiveness directly affect performance. AI systems designed around the realities of energy operations can help support more consi
RevBits and Stony Brook University’s Ethos Lab Establish a Collaborative Partnership to Further the Field of Cyber Security Education and Application9.6.2026 16:15:00 CEST | Press release
Through the partnership, RevBits will provide its full suite of cybersecurity solutions to Stony Brook University’s Ethos Lab, to deliver the capability to advance student education and equip them with the knowledge needed to face modern cyber threats in a realistic, contained environment. Stony Brook University’s (SBU) Ethos Lab, in the College of Engineering and Applied Sciences Department of Computer Science, recently announced a collaborative partnership with RevBits, LLC. Through the partnership, SBU’s Ethos Lab will utilize the RevBits solutions suite to build computer science labs and a cybersecurity-focused curriculum, reinforcing lessons from the classroom. The platform simulates environments containing five major threat landscapes, including Endpoint Security, Privileged Access Management, Email Security, Zero Trust Network and Deception Technology. SBU’s Department of Computer Science was recently designated as a National Center of Academic Excellence in Cybersecurity Resear
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom