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
Compass Pathways Commends White House Executive Order to Accelerate Research and Access for Psychedelic Treatments18.4.2026 22:12:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, welcomes the White House Executive Order on accelerating medical treatments for serious mental illness. “We commend the Administration’s Executive Order on psychedelic treatment which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have,” said Kabir Nath, CEO at Compass Pathways. “Today’s announcement aligns regulatory urgency with patient need, and we applaud the Administration for taking this important step forward in accelerating access, without compromising rigorous science. Compass is conducting the largest, most robust classic psychedelic studies to date with COMP360 synthetic psilocybin. We have recently reported two positive phase 3 trials in treatment-resistant depression (TRD) with highly statistically significant and clinically meaningful data that
2026 NAB Show Opens Tomorrow, Uniting Global Media Leaders to Shape the Future of Storytelling18.4.2026 04:08:00 CEST | Press release
CEO of Zhong, one of YouTube’s most-watched creators with 70 million subscribers and 95 million followers on all platforms, joins program The 2026 NAB Show kicks off Saturday, April 18, with the show floor and exhibits opening on April 19, highlighting the most innovative companies and bringing together the world’s most influential voices across media, entertainment and technology for the industry’s premier global event. As the only platform that convenes broadcasters, media companies, content creators and technology innovators at scale, NAB Show continues its century-long legacy as the catalyst for innovation, growth and deal-making in a rapidly evolving, multi-platform world. From artificial intelligence and the creator economy to sports, streaming and cloud transformation, NAB Show is where the tools, talent and ideas driving the future of storytelling converge. “NAB Show is where the global media ecosystem comes together not just to explore what’s next—but to build it,” said Karen
Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product17.4.2026 23:43:00 CEST | Press release
A pioneer in smoke-free tobacco products, Philip Morris International is the only company that has received modified risk tobacco product authorizations for heated tobacco products.In their order, FDA concluded that: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals” The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes. The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit th
Canva Announces Anthropic Collaboration to Bring AI-Powered Design to Millions17.4.2026 17:51:00 CEST | Press release
New collaboration brings Canva into Claude Design by Anthropic, turning AI-generated ideas into fully editable, on-brand designs Canva, the world’s leading all-in-one visual communication platform, today announced the next chapter in its two-year strategic collaboration with Anthropic, bringing Canva directly into the newly launched Claude Design by Anthropic Labs, one day after unveiling Canva AI 2.0 to a crowd of 6,500 people at Canva Create in Los Angeles.. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260410843169/en/ Canva and Claude Canva is also today introducing HTML importing, a new capability that makes it easy to bring interactive content generated in tools like Claude into the Canva editor for drag-and-drop collaboration, refinement, and publishing. The collaboration makes it easier for Claude Design users to turn AI-generated drafts and ideas into fully editable designs in Canva, where they become collaborative
Andersen Consulting tilføjer samarbejdsfirmaet Nuvolar17.4.2026 15:43:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform for digitale transformation gennem en samarbejdsaftale med Nuvolar, et teknologikonsulenthus med speciale i cloudbaseret softwareudvikling og avancerede Salesforce-implementeringer. Nuvolar, der blev stiftet i 2008 og har hovedsæde i Spanien, leverer end-to-end digital produktudvikling med dyb ekspertise inden for Salesforce, specialudviklede web- og mobilapplikationer, full-stack udvikling, UX/UI-design, produktledelse og langsigtede supporttjenester. Med mere end 110 fagfolk fordelt over Barcelona, Madrid, Miami og Mexico City arbejder virksomheden med kunder inden for luftfart, sundhedsvæsen, forbrugsgoder, medicinalindustrien samt hotel- og restaurationsbranchen for at designe og implementere skalerbare, forretningskritiske platforme, der optimerer driften og fremskynder den digitale transformation. "Samarbejdet med Andersen Consulting giver os mulighed for at levere vores ekspertise i en større skala," udtalte Marc Vivas, administrerende di
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