Pharma/Fine Chemicals Roundup – August 9
5:53 AM MDT | August 9, 2011 | By DEEPTI RAMESH
FDA REPORTS PROGRESS ON DRUG INSPECTION COLLABORATION
The U.S. Food and Drug Administration (FDA) and its international counterparts have released reports on the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally. The report on the active pharmaceutical ingredients (API) initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration, the European Medicines Agency (EMA), France, Germany, Ireland, Italy, the U.K. and European Directorate for the Quality of Medicines & Healthcare (EDQM). Over the course of the 24-month pilot phase, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine collaborative inspections, FDA says. The FDA used these reports to inform decisions, such as whether to postpone or expedite its own inspection. The FDA also prohibited imports into the U.S. of a firm’s products based on the negative findings from a European inspection, FDA adds.
These pilot programs are part of the FDA’s global strategy to ensure the safety and quality of imported products. The FDA increased the number of foreign drug manufacturing inspections by 27% between 2007 and 2009 and has opened several international offices in key locations such as China and India. The agency also recently joined the Pharmaceutical Inspection Cooperation/Scheme, an organization of drug manufacturing inspectorates from 39 countries, FDA says.
ICIG ACQUIRES ROCHE’S API SITE IN U.S.
The International Chemical Investors Group (ICIG; Frankfurt) says it has signed an agreement with Roche (Basel, Switzerland) to acquire Roche Colorado Corp. (Boulder, CO), which includes Roche’s pharmaceutical production facility at Boulder. ICIG will acquire the Roche affiliate company in Boulder with its technical development and small molecule manufacturing capabilities. ICIG will operate the Boulder site and it will be renamed Corden Pharma Colorado. Corden Pharma is the pharmaceutical arm of ICIG investments. Corden Pharma Colorado will supply Roche with a number of active pharmaceutical ingredients (API) that the Boulder site currently produces, under the terms of the deal. Roche Colorado currently has about 265 employees.
“By purchasing the Boulder facility, we position ourselves for a commanding presence in the contract peptide manufacturing industry,” says Wolfgang Niedermaier, president of Corden Pharma. “We are excited to expand the market for the Boulder site’s unique technical capabilities, attracting additional API production opportunities that will build on its existing portfolio of Roche products and other pharmaceutical contract business.”
CHINA’S SFDA TO INTENSIFY SUPERVISION OF CONTRACT MANUFACTURING ASSIGNMENTS FROM OVERSEAS FIRMS
The State Food and Drug Administration (SFDA; Beijing) says that it will intensify the supervision of acceptance of pharmaceutical contract manufacturing assignments from overseas pharmaceutical companies, and it will strictly regulate these contract manufacturing assignments.
IPCA LABORATORIES BUYS ONYX RESEARCH CHEMICALS
Ipca Laboratories (Mumbai) has acquired Onyx Research Chemicals, the holding company of Onyx Scientific (Sunderland, U.K.). Ipca, in its filing to the Bombay Stock Exchange today, said that the acquisition of 100% stake in Onyx Research Chemicals was done through its wholly owned subsidiary Ipca Laboratories U.K. Ltd.
“The acquisition brings together two contract manufacturing organizations to better serve their customers on a global basis,” says Harish P. Kamath, senior v.p./legal and company secretary of Ipca Laboratories.
Onyx Scientific is a supplier to several large pharma and biotech customers. It offers custom synthesis, solid state chemistry, scale-up and cGMP manufacturing up to a few kilogram levels. Ipca Laboratories is a fast growing pharmaceutical major with a strong focus on exports, which now account for 55% of the company’s income. Ipca is vertically integrated and produces finished dosage forms and active pharmaceutical ingredients.
CAMBREX SECURES SALES HIKE, ENJOYS CURRENCY BOOST
Fine chemicals firm Cambrex has recorded Ebitda for the second quarter of the year up 9% to $12.1 million, on corresponding sales up 18% to $67.5 million. Excluding a 10.7% favorable impact of foreign exchange, reflecting a weaker U.S. dollar, sales increased 6.9%. The increase is primarily due to higher sales of certain larger custom manufacturing products and higher volumes of generic active pharmaceutical ingredients (API). These increases were partially offset by the timing of orders for certain products, lower custom development revenues and lower pricing across several product categories.
“We are pleased with our second quarter and year to date performance with sales volumes significantly higher year over year,” says Steven M. Klosk, Cambrex’s president and CEO. “Similar to the first quarter, we saw increases in revenues for some of our larger custom manufacturing products and continued strong orders for our generic APIs. Although profit margins were negatively impacted by foreign exchange, tiered pricing arrangements and production inefficiencies at one of our plants, a continued focus on cost reductions helped mitigate those impacts and contributed to our strong cash flow in the quarter.”
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