GÖTEBORG, Sweden--(BUSINESS WIRE)--Regulatory News:
Vitrolife (STO:VITR) is the first company to receive regulatory approval for an entire IVF culture media portfolio in China. With the approval from Chinese SFDA (State Food and Drug Administration), Vitrolife can now provide a unique level of compliance to the IVF community with products covering all steps of an IVF treatment.
“It has been a long and intense journey to secure that our customers can work with ease of mind, fulfilling regulatory requirements”. We are very proud and happy to be the first company to offer approved quality leading products from retrieval to transfer”, says Dr. Meishan Jin, Vitrolife’s Regional Manager Asia
This approval confirms that Vitrolife brings safe, efficient and certified products in the hands of IVF professionals.
“China experiences very rapid growth in terms of IVF treatments and Vitrolife are one of the companies best positioned to take care of that growth. With this approval, our growth will be further leveraged for the future, says Dr. Magnus Nilsson, CEO Vitrolife”
During the approval process the company has cooperated closely with national authorities, to set the quality standard for IVF-products and secure that customers can work according to Chinese rules and regulations.
The SFDA approval adds to the list of stringent regulatory approvals of Vitrolife products for CE-mark, FDA, Canada Health, TGA accompanied by many local registrations. More information on Vitrolife products and concepts can be found on www.vitrolife.com
Gothenburg, May 5, 2011
VITROLIFE AB (publ)
Magnus Nilsson
CEO
Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation. The Fertility product area works with nutrient solutions (media), cryopreservation products and advanced consumable instruments such as needles and pipettes, for the treatment of human infertility. The Transplantation product area works with solutions and systems to evaluate and maintain organs outside the body in order to select usable organs and keep them in optimal condition while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes.
Vitrolife today has approximately 220 employees and its products are sold in more than 85 markets. The company is headquartered in Gothenburg, Sweden, and there are subsidiaries in USA, Australia, France, Italy, United Kingdom and Japan. Production facilities are located in Sweden and the USA. The Vitrolife share is listed on NASDAQ OMX Stockholm, Small Cap.
Vitrolife AB (publ), Box 9080, SE-400 92 Göteborg, Sweden. Corporate identity number 556354-3452.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
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