Zydus Nycomed’s API plant to start production soon
pharmafile | October 4, 2010 | News story | Manufacturing and Production |Â Â API, India, Nycomed, Zydus CadilaÂ
Nycomed has said that construction and validation of an active pharmaceutical ingredient manufacturing unit at its plant in Navi Mumbai, India, partnered with Zydus Cadila, has now been completed.
The plant is expected to start commercial production before the end of the year, initially supplying three APIs – pantoprazole, urapidil and lornoxicam – with eight more due to come online in 2011.
Nycomed and Zydus Cadila formed a 50:50 joint venture in 1998 to make starting materials for pantoprazole, the API in its big-selling gastrointestinal medicine Protonix, and expanded their collaboration in 2008 to create an API manufacturing hub for the Swiss drugmaker.
The aim was to transfer API production from Nycomed’s facilities in Austria and Germany to India over the following four years.
“The newly commissioned facilities mark the transition of Zydus Nycomed from an intermediate manufacturer to a full-fledged API manufacturer,” said Nycomed in a statement, adding that Navi Mumbai will be the key supplier for its portfolio of branded generics.
Zydus Nycomed intends to have the site audited by the European Medicines Agency and other international regulatory agencies.
Hakan Bjorklund, Nycomed’s chief executive, said the plant represents “a significant step forward to getting high quality APIs … [at] competitive costs.”
Pantoprazole is still a big product in Nycomed’s portfolio, but started to lose patent protection in several key markets in 2009 with additional expiries due this year.
Sales of the drug have been declining in the US and Europe as a result, down 35% in the first half of 2010, but are on the rise in Asia-Pacific markets, the Middle East and Latin America.
Reducing the cost of goods for pantoprazole is expected to help boost its uptake in emerging markets, alongside other products in Nycomed’s branded generics portfolio which was boosted last year by the purchase of product lines sold by Zentiva in Eastern Europe.
Phil Taylor
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