Malta gives Siegfried the generic advantage

By Anna Lewcock

- Last updated on GMT

Related tags European union Pharmacology

Siegfried Generics this week kicked off production at its new
manufacturing facility in Malta making the most of the country's
lack of pharma patents which gives the firm a head-start in
producing generic pharmaceuticals.

The new facility was constructed at a cost of CHF24m (€14.6m) Peter Gehler of the company told in-PharmaTechnologist.com, and is a "fully functioning pharmaceutical facility​" for solid dose forms such as tablets and capsules. The plant will be capable of manufacturing 460m tablets per year, but this capacity will be increased even further to around 1bn tablets following a second phase of work due to be completed in October/November this year. The Malta plant will effectively double Siegfried Generics' production capacity, complementing the company's one other production site in Zofingen, Switzerland. The advantage of the Malta site, however, lies in the fact that very few companies have bothered registering patents there, leaving Siegfried free to work on its generics formulations pretty much unhindered. In other EU countries where pharmaceutical products are covered by patents taken out by the manufacturers, companies are not allowed to begin process development on generic versions until the original patent has expired. This has been a particular nuisance to Siegfried, which has had to work with these constraints compounded by the fact that patents in Switzerland (where its only other site is located) tend to expire a couple of years later than in the EU. "There aren't really any patents registered in Malta, perhaps because big pharma just didn't think it was worth it,"​ Gehler said. "But it means that we can develop, produce and stockpile products and be there the day after a patent expires elsewhere." ​ This could provide the company with a significant advantage in the market, beating other manufacturers who will still be restricted in their activities due to the patent laws. The new plant boasts state-of-the-art equipment and is currently being used to manufacture amlodipine tablets, a generic version of Pfizer's Norvasc which has been the subject of a patent tussle between Pfizer and Mylan Laboratories, who has recently introduced a generic version itself. The firm's expertise lies in tablets, film- and sugar- coated tablets and hard gelatine capsules, for both immediate- and extended-release formulations. Although currently a solid-dose plant, Gehler told in-PharmaTechnologist.com that there is the possibility that it could be used to manufacture other dosage forms should the company decide to go down that route. Maltese regulatory authorities have given Siegfried Generics Malta the thumbs up after carrying out inspections of the new plant, and in December last year the company received production approval allowing manufacturing for the next two years.

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