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
Andersen Consulting styrker rådgivning inden for bygningsaktiver gennem samarbejde med Grinity20.2.2026 23:18:00 CET | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Grinity, et rådgivningsfirma med speciale i bygningsaktiver, der leverer tekniske, miljømæssige og bæredygtige udviklingstjenester til bygge- og ejendomsmarkederne. Med sæde i Tjekkiet og Slovakiet og mere end 130 specialister betjener Grinity private og offentlige kunder inden for kommerciel udvikling, industri, teknologi, bilindustri og bæredygtighed. Virksomheden tilbyder tværfaglig ekspertise inden for projekt- og omkostningsstyring, teknisk rådgivning, transaktionsydelser, ESG-rådgivning og energioptimering af bygninger. "Bæredygtighed er blevet en strategisk nødvendighed, men kunderne har også brug for en integreret ydelse på tværs af omfang, omkostninger, tidsplan, risiko og kvalitet," udtalte Pavel Čermák, administrerende direktør for Grinity. "Ved at kombinere vores ekspertise inden for projekt- og omkostningsstyring, teknisk rådgivning og energioptimering med Andersens globale platform kan vi levere omfattende, fremadsku
Telekom Srbija Group Announces Platinum Sponsorship of EXPO 2027 Belgrade20.2.2026 12:32:00 CET | Press release
Telekom Srbija to power EXPO 2027 and unveil dedicated pavilion showcasing its technology ecosystem Telekom Srbija Group today announced its Platinum Sponsorship of EXPO 2027 Belgrade, marking a major milestone in the company’s continued leadership in digital innovation and infrastructure across the region. As a Platinum Sponsor, Telekom Srbija will play a central role in delivering the digital backbone of EXPO 2027, powering connectivity and enabling the state-of-the-art technological infrastructure that will support one of the largest international events ever hosted in Serbia. EXPO 2027 represents a defining moment for Belgrade, Serbia, and the wider region. For Telekom Srbija, the partnership is both a strategic commitment and a landmark opportunity to demonstrate the full strength of its technological ecosystem on a global stage. Telekom Srbija will also host its own pavilion at EXPO 2027, creating an immersive space to showcase its technologies, innovation platforms and future-fa
Axelspace Secures Japan Ministry of Defense Satellite Constellation Project20.2.2026 12:01:00 CET | Press release
As an optical imagery provider, Axelspace has entered into a contract for the acquisition of image data Axelspace Corporation (“Axelspace”), a leading developer and operator of microsatellites dedicated to realizing its vision of “Space within Your Reach,” announced that, for the purpose of carrying out the Ministry of Defense’s satellite constellation project, it has entered into a contract with Tri-Sat Constellation Co., Ltd. and Mitsui Bussan Aerospace Co., Ltd. for acquisition of optical imagery data. Tri-Sat Constellation Co., Ltd. is a special purpose company (SPC) established by Mitsubishi Electric Corporation, SKY Perfect JSAT Corporation, and Mitsui & Co., Ltd. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260220758297/en/ An imagery of satellite constellation © the Ministry of Defense The Ministry of Defense’s satellite constellation project was awarded to a consortium comprising Mitsubishi Electric Corporation, S
Sai Life Sciences to Recruit 700+ Professionals in FY2720.2.2026 10:09:00 CET | Press release
Sai Life Sciences Limited (BSE: 544306 | NSE: SAILIFE), one of India’s leading integrated contract research, development and manufacturing organizations (CRDMOs), today announced plans to hire 700+ scientific, technical, and management professionals during 2026–27 as it scales capabilities to meet growing global demand for end-to-end drug discovery, development and manufacturing services. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260220711675/en/ Integrated R&D Campus, Sai Life Sciences, Hyderabad, India The recruitment will span roles across medicinal chemistry, biology, DMPK, process and analytical development, formulation development, process engineering, technology transfer, quality, peptides, business development, program management, and manufacturing, among others. A specific area of focus through this recruitment drive will be on attracting high-calibre scientists from leading institutions in India and globally,
Balmain Beauty Introduces Destin de Balmain: A New Prestige Fragrance20.2.2026 08:30:00 CET | Press release
Balmain Beauty unveils Destin de Balmain, its debut prestige fragrance. The new feminine fragrance is a bold, floral fruity eau de parfum that captures the unstoppable energy of the Balmain woman: independent, youthful, and unapologetic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219851364/en/ Destin de Balmain (Photo Credit: Balmain Beauty) THE STORY: LIVE YOUR DESTINY Destin de Balmain is destiny you hold in your hands, a journey of optimism and infinite possibilities. The refillable fragrance unites those who express themselves without rules or expectations. Inspired by the Parisian House’s savoir-faire and modern pulse, the daring fragrance celebrates choosing your path and living your destiny. “Destin de Balmain features a joyful, optimistic spark of ripe strawberry,” said Quentin Bisch, Perfumer. “The fruit’s juicy vivacity brings bright, elevated sweetness to the composition. Notes of peony further convey the f
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