Biomatrix' Manufacturing Receives ISO 9001/EN46001 Certification
Biomatrix, Inc. (Ridgefield, NJ) has received ISO 9001/EN46001 certification of its quality system for the manufacturing of the company's medical therapeutics in its new manufacturing facility in Ridgefield, NJ. Biomatrix' Canadian manufacturing facility also has ISO 9001/EN46001 certification and is in compliance with US Food and Drug Administration Good Manufacturing Practices (GMP).
Endre Balazs, CEO of Biomatrix, stated, "Receipt of ISO 9001/EN46001 certification for our US manufacturing plant is an extremely important milestone for Biomatrix, confirming the high quality standards to which we have always adhered. It recognizes our commitment to the highest quality in design and manufacture of our medical devices. It also signifies that we have successfully completed our new manufacturing plant and the quality systems necessary to operate this facility. Our ability to complete this nearly $30 million construction project and the hiring and training of over one hundred people on schedule is a major accomplishment. This important goal was achieved through the teamwork and commitment to quality which has been and remains the hallmark of Biomatrix' success."
Balazs explained the importance of this certification for entering foreign markets. "Attaining ISO 9001/EN46001 certification permits us to manufacture and ship our product from our US manufacturing facility to the 19 countries of the European Economic Area and a number of countries in Latin America and Asia. This approval of the new manufacturing plant will also permit us to supply the growing demand for our products from companies in these areas. Finally, certification will help us launch our Synvisc and Hylaform products more broadly internationally."
Biomatrix's Hyaluran-based Products
Synvisc, Biomatrix' novel product for the treatment of osteoarthritis of the knee, is marketed in the US, most countries of the European Economic Area, and certain countries in Latin America and Asia. Through marketing and distribution agreements with a number of large multinational pharmaceutical companies, and through its wholly-owned subsidiaries, Biomatrix has contracts to market Synvisc in approximately 90 countries. Wyeth-Ayerst Laboratories has distribution rights and markets Synvisc in the US and certain European countries; Boehringer-Ingelheim in France; Rhone-Poulenc Rorer in Canada; Hoffman La Roche in Sweden and South Africa; Novartis Pharma AG in Latin America; and Bayer AG in Australia, New Zealand and certain countries in Asia.
Biomatrix manufactures and sells other viscoelastic products through distributors: Hylaform, for treating facial wrinkles and depressed scars, is marketed in 21 countries by Collagen Corp; Gelvisc Vet is for treating arthritis in animals; two Hylashield products for the protection of the surface of the eye from noxious environmental conditions; and several polymers for the skin care industry.
For more information: Ann Marie Fields, Biomatrix, Inc., 65 Railroad Ave., Ridgefield, NJ 07657. Tel: 201-945-9550, ext. 267. Fax: 201-945-9550.