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Pharma/fine chemicals roundup—12 March
7:51 AM MDT | March 12, 2013 | By DEEPTI RAMESH
China to establish a more powerful food and drug safety watchdog
The Chinese government says that it will elevate the status of the existing State Food and Drug Administration (Beijing) in order to strengthen regulation and boost people's confidence in the country's food and drug products. The proposed ministry-level General Administration of Food and Drug will replace a large group of overlapping regulators with an entity similar to the US FDA, the government says. Overlapping supervision by various departments and some supervision blind spots are weak links in the current food safety supervision system, the government says.
Ranbaxy’s API business reports rise in sales
The active pharmaceutical ingredient (API) business of Indian pharmaceutical major Ranbaxy Laboratories (Gurgaon, India) recorded sales of 2.14 billion Indian rupees ($39.5 million) in the fourth quarter ended 31 December 2012, compared with sales of Rs2.08 billion in the year-ago quarter. For the full-year 2012, Ranbaxy’s API business recorded sales of Rs7.30 billion compared with sales of Rs6.98 billion in 2011. Profits for the API business were not disclosed.
Ashland to expand pharmaceutical center in Delaware
Ashland says it plans to expand its pharmaceutical research and development unit at the Ashland Research Center at Wilmington, DE. Ashland will expand its existing capabilities to include formulation development and GMP contract manufacturing services for solid dispersions and oral solid dosages. To support early-stage clinical trials, the expansion will include spray drying and extrusion processes previously located at Columbia, MD. About 20 positions will be relocated from Columbia to Wilmington in connection with the expansion, Ashland says. The company expects the new facility to be operational by summer 2014. Ashland currently has pharmaceutical technology centers at Buenos Aires; São Paulo; Shanghai; Düsseldorf; Hyderabad, India; Istanbul; and Mexico City, in addition to Wilmington.
Dow names new pharma and food solutions head
Dow Chemical announced that is has named Marc van Gerwen global business director for Dow’s pharma and food solutions unit, formally known as Dow Wolff Cellulosics. Van Gerwen has been with Dow since 2007 as strategic planner for Rohm and Haas’s Europe, Mideast, and Africa region. In 2009, he joined Dow's microbial control business as global commercial director, where he helped move the business into shale gas. In 2011, he joined Dow Wolff Cellulosics as global marketing and sales leader. Van Gerwen succeeds Martin Sonntag, who is leaving the company.
DBV Technologies signs API manufacturing deal with Sanofi
DBV Technologies (Bagneux, France) says it has entered into a manufacturing agreement with Sanofi (Paris) to produce Viaskin’s active pharmaceutical ingredients (API). Viaskin is a new standard in the treatment of allergies, DBV says. “The strategic manufacturing agreement with Sanofi is an important step for DBV in the light of Viaskin’s late-stage development and potentially fast-coming commercialization,” says Pierre-Henri Benhamou, chairman and CEO of DBV. “We believe that the extraction and protein expertise of Sanofi, notably at the Aramon [France] site, will highly benefit DBV, thereby securing our API procurement in the years to come.”
DSM Sinochem launches new API
DSM Sinochem Pharmaceuticals (DSP; Singapore), the former DSM Anti-Infectives business, says it has added Puriclor (cefaclor) to its DSMPureActives range of enzymatically produced active pharmaceutical ingredients (API). Puriclor, a second-generation cephalosporin antibiotic, is used to treat bacterial infections such as pneumonia as well as ear, throat, and urinary tract infections. DSM and Sinochem completed a deal in August 2011 to establish a 50-50 joint venture for the DSM Anti-Infectives business. Sinochem acquired a 50% stake in DSM Anti-Infectives for €210 million ($273 million), creating DSP. The jv develops, produces, and sells raw materials, intermediates, and APIs for anti-infectives such as antibiotics and antifungals, and APIs for other therapeutic classes such as cholesterol-lowering medicines. Puriclor is the first second-generation semisynthetic cephalosporin (SSC) product to be produced in DSPs new multiproduct plant at Zibo, China. The launch of Puriclor allows DSP to further drive its growth in SSCs and perfectly fits in the company strategy of strengthening the beta-lactam business and broadening DSP’s API portfolio, the company says.