CROMA-PHARMA-GMBH
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
ARAMIS Global Ambassador, Dwyane Wade, Celebrates New Fragrance Launch During New York Fashion Week13.9.2025 19:13:00 CEST | Press release
Heritage men’s fragrance brand, ARAMIS, officially launched its new scent, Intuition, with global ambassador, Dwyane Wade, during New York Fashion Week. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250913048158/en/ ARAMIS Global Ambassador, Dwyane Wade, attends Brand’s NYFW Pop-Up at The High Line (Courtesy of BFA ) The celebration kicked off with an immersive pop-up on New York City’s iconic High Line, where guests explored the story behind the fragrance through scent, sound, and design. Dwyane Wade made a personal appearance at the interactive event, joined by his wife, actress Gabrielle Union. Later in the afternoon, Wade participated in an intimate conversation around personal grooming, fragrance, and modern masculinity at Bloomingdale's 59th Street. Moderated by Mike Muse, the conversation also featured Donato Smith, Wade's longtime barber, and friend. Bloomingdale’s top clients were given the opportunity to connect i
SUI Group Announces Completion of Existing $2 Million Stock Repurchase Program and Subsequent Authorization of New $50 Million Program12.9.2025 22:05:00 CEST | Press release
SUI Group Holdings Limited (“SUI Group,” “SUIG” or the “Company”) (NASDAQ: SUIG), the only publicly traded company with an official relationship with the Sui Foundation, today announced it has completed its previously authorized $2 million stock repurchase program. SUI Group is also announcing that its Board of Directors has now authorized a new stock repurchase program to acquire up to an additional $50 million of the Company’s common stock. Following the completion of its initial stock repurchase program, in which the Company repurchased approximately 318,743 shares of its common stock at an average price of $4.30 per share between September 10, 2025 and September 12, 2025, SUI Group’s new program provides the flexibility to support its Net Asset Value (“NAV”) per share by opportunistically purchasing its common stock. The Company believes that share repurchases at these levels are immediately accretive to existing stockholders and reflects its confidence in its underlying fundamenta
Andersen Consulting udvider sine kapaciteter i Asien og Stillehavsområdet med VDB Loi12.9.2025 17:43:00 CEST | Pressemeddelelse
Andersen Consulting udvider sine kapaciteter i Cambodja, Vietnam og Laos, da VDB Loi føjer rådgivningsydelser til sit eksisterende udbud af tjenester inden for skat og jura. VDB Loi, som ledes af administrerende direktør Jean Loi, der også fungerer som administrerende direktør for Andersen i Cambodja og Vietnam, blev grundlagt i 2012 som et skatte- og advokatfirma og har siden 2021 samarbejdet med Andersen Global. Med tilføjelsen af dets samlet udvalg af konsulentydelser er VDB Loi nu medlem af Andersen Consulting og tilbyder helhedsorienterede løsninger inden for forretningsstrategi, kunstig intelligens, teknologisk transformation og cybersikkerhed, hvilket komplementerer firmaets eksisterende platform til forhold inden for skat og jura. "Vi har været en del af Andersen-familien i flere år nu og anerkender den værdi og synergi, denne tværfaglige tilgang giver vores klienter," udtalte Jean. "I det nuværende erhvervsklima er det ikke tilstrækkeligt kun at være et skattefirma eller et ju
Allied Nations Gather to Discuss Future of Multilateral Defence Security Financing12.9.2025 17:35:00 CEST | Press release
The Defence, Security and Resilience Bank (DSRB) Development Group co-hosted an international conference in the City of London this week to discuss the creation of a new multilateral bank designed to bring capital market expertise to the frontlines of global security. The event at Mansion House, co-hosted by the Lord Mayor of London, included 72 attendees from 37 countries across the NATO alliance, the EU, and Indo-Pacific allied nations. Held on the eve of the Defence and Security Equipment International (DSEI event), the DSRB “Information Day” event also included a further 88 attendees from a wide range of institutions including the European Union, NATO, eight partner commercial banks, multiple development and central banks as well as representatives from global funds, ratings agencies, industry associations and think tanks. Notes to Editors: The DSR Bank Development Group is a non-profit working toward the establishment of the full bank alongside nation states and institutions. The
Illumination and Nintendo Announce the New Animated Film Based on the World of Super Mario Bros. Will Be Titled The Super Mario Galaxy Movie12.9.2025 15:33:00 CEST | Press release
Illumination (HQ: Santa Monica, CA, USA; Founder and CEO: Chris Meledandri) and Nintendo Co., Ltd. (HQ: Kyoto, Minami-ku, Japan; Representative Director and President: Shuntaro Furukawa, “Nintendo” hereafter) today announced that the title of the new animated film based on the world of Super Mario Bros., will be The Super Mario Galaxy Movie. The film will be released worldwide by Universal Pictures beginning April 3, 2026. In addition, the two companies announced that the returning voice actors for the characters will be: Mario (Chris Pratt), Princess Peach (Anya Taylor-Joy), Luigi (Charlie Day), Bowser (Jack Black), Toad (Keegan-Michael Key), and Kamek (Kevin Michael Richardson). The additional characters and voice cast for The Super Mario Galaxy Movie will be announced at a later date. The Super Mario Galaxy Movie will be released on April 3, 2026 in the US and many additional markets globally, and will be released on April 24, 2026 in Japan, with select territories releasing through
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