Pharma/fine chemicals roundup—28 May
10:08 AM MDT | May 28, 2013 | By DEEPTI RAMESH
India outlines API export norms, to comply with new EU regulations
India’s Ministry of Commerce & Industry (New Delhi) says that it is taking action in order to ensure that active pharmaceutical ingredients (APIs) exported from India into the European Union meet the new EU standards and regulations, which will become effective on 2 July. To comply with the EU requirements, the Indian government declared the Central Drugs Standard Control Organization (CDSCO; New Delhi) as the "competent authority" in India that can confirm the quality of the APIs exported to the European Union; the CDSCO has also laid down a protocol for India API exporters to follow to comply with EU regulations.
FDA issues warning letter to Boehringer Ingelheim API plant
FDA issued a warning letter earlier this month to the active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facility Boehringer Ingelheim (Ingelheim am Rhein, Germany) for violations of cGMP. An FDA inspection of the facility from 5–12 November 2012 identified significant violations of cGMP for the manufacture of APIs and the cGMP regulations for finished pharmaceuticals, FDA says. The violations for the manufacture of APIs at the Ingelheim am Rhein site include failure of the company’s quality unit to thoroughly investigate critical deviations in the manufacturing of APIs and failure to conduct investigations regarding the presence of foreign particles found in the APIs, FDA says.
Novo acquires Xellia Pharmaceuticals in $700-million deal
Novo (Hellerup, Denmark), parent of pharmaceutical firm Novo Nordisk (Bagsvaerd, Denmark), has acquired Xellia Pharmaceuticals (Oslo) from private equity firm 3i (London) for an enterprise value of $700 million, 3i and Novo have announced. The closing of the transaction is expected to take place during the third quarter. Xellia specializes in anti-infective products for multidrug-resistant infections. "When the management team bought out Xellia in 2008, we had ambitious plans, which we were able to implement with 3i's support. We have successfully transitioned the business," says Carl-Åke Carlsson, CEO of Xellia. "Now, as we focus on the future and the further development of the business, including the launch of our novel antibiotics pipeline, we look forward to working with Novo and benefitting from their expertise in the life science sector."
Bayer HealthCare appoints new CIO
Bayer says that Johannes Schubmehl was appointed CIO of Bayer HealthCare on 1 May. He succeeded Matthias Moritz, who left the company at the end of March. Schubmehl has held various managerial positions in the Bayer group since 1999. From 2006–10 he was CIO of Bayer CropScience and then transferred to Bayer Business Services, where he was responsible for the human resources services unit with about 1,000 employees worldwide. Bayer HealthCare, a subgroup of Bayer, had sales of €18.6 billion ($23.9 billion) in 2012, and is based at Leverkusen.
AstraZeneca acquires specialty pharma company Omthera for $323 million
AstraZeneca has agreed to acquire Omthera Pharmaceuticals (Princeton, NJ), a specialty pharmaceutical company focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia. AstraZeneca will acquire Omthera for $12.70/share, or approximately $323 million.
Beyond IHS Chemical Week:
Ranbaxy looks to rebuild quality reputation as Daiichi vows legal action
Ranbaxy Laboratories is putting all of its weight behind a quality push following its admission of manufacturing adulterated drugs just as its parent company, Daiichi Sankyo, is pursuing legal action. The latest quality efforts follow Ranbaxy's agreement to pay $500 million to the US Department of Justice after lying to FDA, manipulating data on its manufacturing processes and knowingly manufacturing adulterated drugs.
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