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Pharma/Fine Chemicals Roundup – July 24
1:37 PM MDT | July 24, 2012 | By DEEPTI RAMESH,&NBSP;SOTIRIOS FRANTZANAS, AND VINCENT VALK
NOVASEP EXPANDS HPAPI MANUFACTURING FACILITY IN FRANCE
Novasep (Pompey, France) says it will expand its highly potent active pharmaceutical ingredients (HPAPIs) manufacturing capabilities at the company's Le Mans, France, facility. The investment is €3 million ($3.7 million). The plant's expansion is expected to be fully operational by the beginning of 2013, the company says.
EUROPEAN API SALES TO REACH $38.25 BILLION BY 2017
The total revenue generated by the European active pharmaceutical ingredient (API) market was $26.28 billion in 2011 and is expected to grow at a CAGR of 6.5% to reach $38.25 billion by 2017, says a recent report by GBI Research. This growth will be supported by healthy demand from both the generic and biotech API sectors, the report says. Europe is the third largest regional market for APIs by revenue in the world, and the European API market revenue accounted for about 24.2% of the global API market revenue of $108.6 billion in 2011, the report says.
SCINOPHARM SIGNS API MANUFACTURING DEAL WITH VIVUS
API manufacturer ScinoPharm Taiwan (Shanhua, Taiwan) says it will commercially manufacture topiramate API for biopharmaceutical company Vivus’s (Mountain View, CA) newly-approved anti-obesity drug, Qsymia. ScinoPharm will manufacture the topiramate API at its Tainan, Taiwan, facility. The U.S. FDA approved Qsymia for the treatment of obesity on July 17. Topiramate is an API that ScinoPharm began commercially producing two years ago as a generic API for the treatment of epilepsy and other nervous system disorders. With this approval for weight management, the market potential for topiramate is expected to increase substantially, ScinoPharm says.
SIEGFRIED TO EXPAND PRODUCTION SITE AT ZOFINGEN
Siegfried (Zofingen, Switzerland), a producer APIs, intermediates, and finished drugs, says the company will expand its production site at Zofingen. The site produces pharmaceutical ingredients and finished drug products. Siegfried says that it will exchange land with the city of Zofingen and StWZ Energie, the Zofingen public utility company. Siegfried will thereby obtain land that directly borders its premises and which can be used for expansion, the company says. The city of Zofingen, in exchange, acquires property available for the expansion of local companies or the settlement of new businesses and production facilities, while StWZ Energie gains land suitable for the relocation of its administration and operations buildings. Agreements concerning the exchange of over 80,000 sq meters of land have been signed.
EMA FORMS PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE
The European Medicines Agency (EMA; London) says it has recently formed the Pharmacovigilance Risk Assessment Committee (PRAC), whose first meeting was held last week. The new committee will play a major role in overseeing the safety of medicines in the European Union. The PRAC is one of the main outcomes of the new pharmacovigilance legislation that came into operation on July 1, 2012, EMA says. The legislation aims to save lives by strengthening the European system for monitoring the safety of medicines.
DKSH JOINS RX-360
DKSH (Zürich, Switzerland), the market expansion services group, says its performance materials business unit has been accepted as a new Rx-360 member, making it one of only a few chemical distribution companies in the international pharmaceutical supply chain consortium. Rx-360 is a pharmaceutical and biotech industry consortium that was formed in 2009 by industry leaders to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. To join Rx-360, DKSH had to meet the consortium's membership criteria and agree to comply with Rx-360's policies. “This is a valuable complementary addition to our service portfolio and guarantees our customers that they can rely on an absolute safe supply of active pharmaceutical ingredients (APIs) and excipients,” says Hansjörg Jakubetz, v.p./pharmaceutical industry, DKSH performance materials.
FOSTER WHEELER RECEIVES CONTRACT FOR API PLANT CONVERSION IN U.K.
Foster Wheeler says that one of its global engineering and construction group subsidiaries has been awarded an engineering, procurement, and construction management (EPCM) services contract by Epax Pharma UK (Middlesbrough, U.K.), a subsidiary of Trygg Pharma (Oslo). Foster Wheeler will convert parts of the former Lundbeck pharmaceutical plant at Seal Sands, U.K., under the terms of the EPCM services contract, to enable the production of an omega-3 API from fish oil. Financial terms of the contract were not disclosed.
DSM SIGNS MANUFACTURING DEAL IN BRAZIL
DSM’s pharmaceutical division has signed its first contract manufacturing agreement in South America, the company says. Under the agreement, DSM with work with Recepta Biopharma (São Paolo) on process development and manufacture of Recepta’s antibodies at the company’s site in Groningen, Netherlands. Recepta is working on developing monoclonal antibodies for cancer treatment.