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Pharma/fine chemicals roundup—3 June 2014
4:58 AM MDT | June 3, 2014 | By DEEPTI RAMESH
FDA scaling back API facility inspections in US; Socma asks FDA to ensure frequency of inspections does not exceed three years
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of Socma, issued a letter on 27 May to the US Food and Drug Administration (FDA) asking that the agency ensure the frequency of inspections for any domestic active pharmaceutical ingredient (API) manufacturer remains consistent. It was recently disclosed that the FDA would be scaling back by nearly 40%, the number of domestic API inspections it plans to conduct in fiscal years 2014 and 2015, in order to increase the number of foreign inspections. BPTF, which is an association for manufacturers of APIs, excipients and intermediates, says it is alarmed at the reduction in inspections. This could result in the failure of a number of compliant API manufacturers to receive safety inspections in a timely manner and not meet the agency's generic drug user fee amendments (GDUFA) commitment of inspecting domestic API manufacturers within a three-year cycle, BPTF says.
Aurobindo Pharma reports rise in API sales
The active pharmaceutical ingredient (API) business of Aurobindo Pharma (Hyderabad, India) reports a 1.4% rise in sales in the company’s fiscal fourth quarter, ended 31 March 2014, compared with the year-ago quarter, to 7.54 billion Indian rupees ($127 million). For the full fiscal year ended 31 March, the API business reports a 12.9% increase in sales, compared with the previous fiscal year, to Rs28.64 billion. Earnings figures for the API business have not been disclosed. Cephalosporin accounted for Rs8.75 billion of Aurobindo’s total API sales in the fiscal year, semisynthetic penicillin accounted for Rs9.77 billion, and nonbetalactam accounted for Rs10.11 billion. Aurobindo is one of the global leaders in APIs.
Cambrex appoints new board member
Cambrex (East Rutherford, NJ) says that James Winschel, Jr. has been appointed to the company's board of directors for a term expiring on the date of its 2015 annual meeting and will serve on the board's audit committee and regulatory affairs committee. Winschel's appointment maintains the size of the board at nine members following John Miller's retirement in April, the company says.
WuXi PharmaTech opens HPAPI laboratory at Shanghai
WuXi PharmaTech (Shanghai, China), a pharmaceutical, biotechnology, and medical device R&D services company with operations in China and the United States, says that its manufacturing subsidiary, Syn-The-All Pharmaceutical Co. (STA), has opened a high-potency active pharmaceutical ingredient (HPAPI) laboratory at Shanghai, thereby adding HPAPI processing to its portfolio of services. The lab will support process development and clinical-trial supply of high-potency small molecules at kilogram scale. “With the increasing use of HPAPIs in drug discovery and development, this new service augments WuXi's ability to provide highly efficient and cost-effective solutions for our partners worldwide,” says Ge Li, chairman and CEO of WuXi PharmaTech.
Lonza appoints new executive committee member
Lonza says it has appointed Sven Abend as member of Lonza’s executive committee effective 1 July. Abend, currently CEO of Kolb (Hedingen, Switzerland), will be primary responsible for corporate strategy and business development, as well as consumer care and industrial solutions.
AMRI to acquire OsoBio for $110 million
Albany Molecular Research Inc. (AMRI; Albany, NY) says that it has signed a definitive agreement to acquire Oso Biopharmaceuticals Manufacturing (OsoBio; Albuquerque, NM) for $110 million in cash. OsoBio is contract manufacturer of highly complex, injectable drug products, including sterile liquid, suspension, and lyophilized formulations. The acquisition is expected to be completed in the third quarter. OsoBio's forecast full-year 2014 revenue is $58–60 million, with adjusted Ebitda of $9–10 million, AMRI says.