Ranbaxy Recalls Generic Lipitor
Ranbaxy, the 600 College Road-based subsidiary of Ranbaxy Laboratories, India’s biggest drugmaker, has recalled dozens of lots of its generic version of Lipitor because some may contain tiny glass particles.
The company posted a notice on its U.S. website on November 23 that it is recalling 10-, 20-, and 40-milligram doses of tablets of its generic version of cholesterol drug Lipitor — atorvastatin calcium.
‘‘Ranbaxy is proactively recalling the drug product lots out of an abundance of caution,’’ said the website statement. ‘‘This recall is being conducted with the full knowledge of the U.S. FDA.’’
The recall is the latest in a string of manufacturing problems that have caused the federal government to bar imports of the company’s medicines in the past, alleging quality lapses at Ranbaxy factories and that that the company lied about test results for more than two dozen of its generic drugs.
In 2008 the FDA found that there were manufacturing defects at two of the company’s plants in India and banned the company from to import more than 30 drugs.
Despite the ban, the FDA decided in November, 2011, to allow the company to sell generic Lipitor made at the company’s Ohm Laboratories, located in New Brunswick, North Brunswick and also at 600 College Road East. It has not been specified which facility manufactured the recalled drug.
In December the FDA entered into a settlement with the company that requires Ranbaxy to improve manufacturing procedures, ensure data on its products is accurate, and undergo extra oversight and review by an independent third party for five years.
Ranbaxy also set aside $500 million to resolve all potential civil and criminal liability related to the investigation. The company also agreed to relinquish 180-day marketing exclusivity for three pending generic drug applications.
Ranbaxy Inc., 600 College Road East, Suite 2100, Princeton 08540; 609-720-9200; fax, 609-720-1155. Dipak Venkat Krishnan, senior vice president and regional director, Americas www.ranbaxyusa.com.
IntelleRep, 103 College Road East, Princeton 08540; www.intellerep.com.
IntelleRep, a pharma marketing company, has vacated its office at 103 College Road East. The company’s phone and fax lines have been disconnected and a message on its website states, “Sadly IntelleRep has closed.”
The startup, which was the focus of a story in the October 17 issue of U.S. 1, moved into the 8,000-square-foot office in February after signing a five-year lease. IntelleRep focused on using a mix of telemarketing and technology to help pharma companies market their products.
Maguire-Burke Agency, 3865 Nottingham Way, Hamilton 08619 609-587-2707; fax, 609-586-9107. Robert J. Burke, broker.
Maguire-Burke Realtors has moved to 3865 Nottingham Way from 3635 Quakerbridge Road. The agency, founded in 1953 by broker/president Robert J. Burke, concentrates on commercial and residential home sales and leasing.