Drug Shortages: Despite Gains, Many Drugs are Still in Short Supply

A recent article from Bloomberg noted that “as shortages of sterile injectables persist, the makeup of that part of the industry is in flux.”  To address the current marketplace struggles,  Mylan has agreed to buy Agila Specialties, the injectables unit of Strides Arcolab, for $1.6 billion, and analysts think Claris Lifesciences could be next, saying “it is a matter of supply and demand.”    Claris has five (5) FDA-sanctioned manufacturing facilities in Ahmedabad, and an analyst tells Bloomberg it might be worth about $500 million.  Claris has “a ready-made facility,” Ranjit Kapadia, an analyst at Centrum Broking in Mumbai, said in a telephone interview. “There’s a scarcity of injectable facilities in the global space, and in the U.S. there’s a shortage of injectable products, so this may lead to an acquisition.”  Claris was itself barred from selling its products in the U.S. after the FDA found it was producing contaminated drugs and failed to fully investigate the cause, according to a 2010 warning letter from the agency. Claris was told in August 2012 that it had addressed the complaints and was allowed to resume U.S. sales. Last month, it got FDA approval for its ninth drug.  There are shortages of sterile injectable drugs in the U.S. and growing demand, but only a limited number of FDA-approved plants to make them.  “Manufacturing injectable drugs requires sterile facilities to protect against unwanted contaminants, and the FDA has crac...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs