Our History

Syntese is the Danish word for ‘synthesis’ and our company is indeed a synthesis of expertise, experience and excellence. We have been a work in progress for nearly 30 years – and we are committed to ongoing improvement of our Mesalazine so that it remains the best on the market.

Our history began in the early 1980s when a Ferring Group team in the Synthesis department invented the 5-ASA purification process that was to become the cornerstone of our business.

The product
In 1986 Ferring launched Pentasa® – a treatment for inflammatory bowel diseases that was based on Mesalazine. The demand for Mesalazine has been increasing ever since, as it is the only active pharmaceutical ingredient free of side effects that has been successful in helping people with inflammatory bowel diseases. We supply pharmaceutical companies with this ingredient to use in their own formulas, resulting in various kinds of medication for patients with the diseases.

The plant
In order to meet increased demand, a new plant was set up in Copenhagen and came on stream in 1992. A subsidiary of Ferring Pharmaceutical A/S, Syntese has been growing steadily ever since and is now among the world’s biggest manufacturers of Mesalazine – and still the only company that is dedicated only to Mesalazine and nothing but.

Even though we are continuously honing our production process, we have stared to outgrow our plant and are looking for new ways to expand production.

The process
In the beginning, we produced Mesalazine solely by purifying technical grade 5-ASA, but our ambition was always to create the molecule ourselves. By using water-based coupling chemistry, our R&D team collaborated with our production team in order to develop a synthesis of technical grade 5-ASA. It was a big year for us when this resulted in the implementation of our own validated synthesis process in 2001.

The certifications
As we supply to pharmaceutical companies worldwide, our registrations and certifications have to be unwaveringly correct and up to date at all times. So this has always been a top priority for us. We pride ourselves in being experts in certification and often act as consultants to our clients, making use of the experience we have acquired all over the world.

We filed our first European DMF on the new process in 2001 and a Canadian DMF, based on USP specifications, in 2002. In 2005 we obtained a Certificate of Sustainability from EDQM.

Our next major milestone was the submission of a US DMF to the FDA in 2006, which was followed by a successful FDA audit in 2007.

In 2011 we achieved the advanced ISO 14001 (environmental management) certification.

In 2013 Syntese achieved the occupational health and safety management systems’ certification  – DS/OHSMS 18001:2008.

 

 


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