28 January 2015: Recipharm, the leading contract development and manufacturing organisation (CDMO), is pleased to announce its readiness for serialisation and the successful completion of a complex serialisation project for China on behalf of one of its customers. A new regulation determining serialisation was introduced by the Chinese regulatory authority with strict importation deadlines set in place offering zero flexibility on full compliance.
Recipharm has developed a highly adaptable solution utilising a meticulous and methodical approach proven to ensure full and complete compliance. Fifty seven (57) serialised batches have already been supplied since February 2014.
The project, for a top ten pharmaceutical company was achieved in record time and a number of strategies to anticipate delays were adopted. Advanced planning ensured that all suppliers were thoroughly vetted and meticulously selected during the period between February and June 2013 with orders placed in early July of that year.
Integration was key, with Recipharm working closely with the pharmaceutical customer, forming project teams and a joint steering committee. Costs were minimised and success ensured via the constant interchange of ideas and information. New technology was also introduced and applied to ensure each individual box has its own 1D barcode and unique serial number.
Stéphane Guisado, General Manager at Recipharm Fontaine commented: “We are very pleased with the success of this China focused serialisation project carried out for the pharma partner concerned. Traditionally, full compliance with China’s regulations, especially in the field of serialisation, has proved to be a major challenge for the pharma sector. There is no room for compromise when it comes to meeting regulatory deadlines. Moreover, the time-lines set by laws have to be met in full and on time and are often imposed with relatively short notice regarding implementation lead time.” He continued:”Consequently, Recipharm as a forward looking CDMO, has now developed the skills and knowledge to provide a platform for delivering a serialisation solution for all markets.”
For further information please visit www.recipharm.com or contact:
Stephane Guisado, General Manager Recipharm Fontaine, stephane.guisado@recipharm.com, Tel: +33 3 8044 7833 Amine Tahiri, Commercial Manager Recipharm Fontaine, amine.tahiri@recipharm.com, Tel +33 3 8044 7805 For media enquiries, please contact Tristan Jervis or Alex Heeley at De Facto Communications on: E-mail: t.jervis@defacto.com or a.heeley@defacto.com, Tel: +44 (0) 207 861 3019/3043
About Recipharm
Recipharm is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry based in Sweden employing some 2,200 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material including API and pharmaceutical product development. Recipharm manufactures more than 400 different products to customers ranging from Big Pharma through to smaller research- and development companies. Recipharm’s turnover is approximately SEK 3.3 billion and the Company operates development and manufacturing facilities in Sweden, France, the UK, Germany, Spain, Italy and Portugal and is headquartered in Jordbro, Sweden. The Recipharm B-share (RECI B is listed on NASDAQ Stockholm. For more information on Recipharm and our services, please visit www.recipharm.com.
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