Pharma/Fine Chemicals Roundup – April 3
8:21 AM MDT | April 3, 2012 | By DEEPTI RAMESH
LONZA APPOINTS RICHARD RIDINGER AS CEO
Lonza says its board of directors has elected Richard Ridinger, 53, as the company’s new CEO effective May 1, 2012. Earlier this year, Lonza fired CEO Stefan Borgas following a series of weak financial results. Lonza recorded a 45.8% fall in net profits for 2011, to SF154 million ($169 million). Sales increased 0.4% last year, to SF2.69 billion. Rolf Soiron, Lonza chairman, has been the acting CEO since the end of January 2012. Richard Ridinger has held several leadership functions at Henkel for 14 years and at Cognis for 11 years. Most recently, Ridinger was responsible for care chemicals, the largest sector at Cognis with about 3,000 employees. Following the takeover of Cognis by BASF at end of 2010, Ridinger supported the integration of the company.
SHASUN TO BUILD NEW MANUFACTURING PLANT IN INDIA
Shasun Pharmaceuticals (Chennai, India), a manufacturer of active pharmaceutical ingredients (APIs), intermediates, excipients, and formulations, plans to invest about Rs2.5 billion ($49 million) in the current fiscal year ending March 31, 2013, to expand its activities, say press reports. The expansion will include building a new manufacturing plant at Visakhapatnam, India, and increasing the production capacity of existing plants.
FDA WARNS AGAINST USING TWO PHTHALATES AS EXCIPIENTS
The U.S. FDA, in a draft guidance, recommends that the pharmaceutical industry avoid using two specific phthalates - dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) - as excipients in drug and biologic products., due to the potential risk to human health. The FDA has determined that there is evidence that exposure to DBP and DEHP from pharmaceuticals may lead to developmental and reproductive issues in humans.
PIRAMAL OPENS ANTIBODY DRUG CONJUGATES FACILITY IN SCOTLAND
Piramal Healthcare (Mumbai) has opened a facility for producing antibody drug conjugates (ADC), for cancer drugs, at Grangemouth, Scotland. The manufacturing facility received £145,000 of Scottish Enterprise funding. These new drugs will be reviewed for a European licence soon – providing an opportunity for them to be considered for use in the NHS in Scotland ahead of the rest of the UK. Within the global API industry, niche technologies such as ADCs, highly potents, cytotoxics, are growing considerably, according to fine chem manufacturers.
RANBAXY RESUMES EXPORTS TO U.S.
Ranbaxy Laboratories (Gurgaon, India) says it has begun exporting formulations to the U.S., four years after a ban on certain Ranbaxy drug imports by the U.S. FDA. In 2008, the FDA halted imports of generic drugs made at two of Ranbaxy’s Indian plants, and the agency issued two warning letters to Ranbaxy for deviating from GMP standards relating to the company’s generic pharmaceutical production plants at Dewas and Paonta Sahib, India. Ranbaxy says it has begun exporting atorvastatin calcium oral tablets to the US market, from its facility at Mohali, India, starting March 2012. “The resumption of supplies from India into the U.S. market is a significant milestone for Ranbaxy. This is a testimony to our commitment to provide quality affordable medicines to the U.S. healthcare system. Going forward, our Mohali facility will cater to the U.S. and other geographies,” says Arun Sawhney, CEO and managing director of Ranbaxy.
Ranbaxy's formulations facility at Mohali was approved by the FDA in October 2011, and in the first quarter of 2012, the company received approval from the FDA to manufacture and market atorvastatin 10mg, 20mg, 40mg and 80mg strength tablets. Ranbaxy launched the first generic version of Pfizer’s cholesterol-lowering drug Lipitor - atorvastatin calcium tablets - in the U.S. market on December 1, 2011. Ranbaxy Pharmaceuticals (Jacksonville, FL) USA, a subsidiary of Ranbaxy received final approval from the FDA to manufacture and market atorvastatin. Lipitor, the top-selling drug, generated annual sales of about $7.89 billion in the U.S. The drug is manufactured by Ranbaxy’s Ohm Laboratories subsidiary at New Brunswick, NJ. The supply of atorvastatin tablets from India supplements the company’s current production from Ohm Laboratories, Ranbaxy says. The new facility at Mohali will manufacture oral solid products for export to U.S., European Union and other countries based on filings and after receiving the necessary approvals, Ranbaxy says.
SANOFI TO ACQUIRE ANTIRETROVIRAL PORTFOLIO FROM HETERO DRUGS FOR SOUTH AFRICA
Sanofi (Paris) says it has signed a definitive agreement for the acquisition of an antiretroviral (ARV) product portfolio from Hetero Drugs (Hyderabad, India), a leading manufacturer of active pharmaceutical ingredients (APIs) and finished drugs. Through the acquisition, Sanofi will deliver ARV products at affordable prices and increase the manufacturing offer for ARV products in South Africa, as the entire product portfolio will be manufactured locally by Sanofi in South Africa. This agreement follows the government’s priority to secure supply and create local jobs while providing medicines at affordable prices, Sanofi says. “Sanofi is committed to supporting and enabling the South African government to reach its goal of providing 80% of all patients access to locally manufactured antiretroviral product in this decade,” says Christopher A. Viehbacher, CEO of Sanofi. Sanofi says it is the leading pharmaceutical company in Africa with sales of about €1 billion in 2011. Sanofi employs 4,400 people in the continent.
Earlier this year, Lonza said it is in discussions with the South African government for establishing a joint venture called Ketlaphela to build an active pharmaceutical ingredient (API) manufacturing facility for anti-retroviral medicines in South Africa.
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