US FDA has denied approval for Daiichi-Ranbaxy’s generic tamsulosin hydrochloride tablets to treat enlarged prostate due to the ongoing controversy on good manufacturing practice norms violations, reports said.
Tamsulosin, which is currently sold under the brand name Flomax was originally developed by Yamanouchi Pharmaceuticals which is now part of Astellas Pharma of Japan.
Tamsulosin is marketed by Boehringer-Ingelheim and CSL under license.Flomax enjoyed a sale of nearly $1.2 bn in US during the year 2009, reports indicate.
Ranbaxy, which is currently owned by Japanese drugmaker Daiichi Sankyo, was scheduled to launch the generic version of tamsulosin on March 2 in the US.
The Indian generic company could have launched tamsulosin eight weeks before the drug’s patent expiry following an out-of-court settlement in 2007.
Ranbaxy has been denied the approval for tamsulosin generic because of its failure to address the manufacturing violations in some of its facities in India and US.
Recently, US FDA has asked Ranbaxy to undertake concrete steps to ensure that all of the company’s facilities involved in manufacturing products to US market confirm with the regulator’s cGMP requirements.
Ranbaxy has been issued warnings for manufacturing violations at least thrice during the last four years by USFDA.
“FDA expects Ranbaxy immediately to undertake a comprehensive assessment of its global manufacturing operations to ensure that all sites manufacturing drug for the US market conform to US requirements,” US FDA alerted in its latest warning letter citing several violations of current Good Manufacturing Practices (cGMP) in its liquid manufacturing facility Ohm Laboratories.
During inspections carried out in Ohm Laboratories,Inc., located at 34 West Fulton Street, Gloversville, NY. in July 13 through August 12, 2009 the US FDA investigators identified significant violations from cGMP regulations for finished pharmaceuticals.
US FDA inspectors listed out several deviations in cGMP practice including failure of a batch of manufactured formulations or any of its components to meet its specifications, failure to comply with its written stability program,lack of laboratory control mechanisms and documented the execution of laboratory control functions at the time of performance, non-compliance with appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity,inadequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. improper equipment, post-marketing violations etc.
Even though Ranbaxy submitted responses to the warning letter on September 11,2009, October 12, November 11, and December 11, 2009 indicating the status of and timeframes for the September 2009 proposed corrective actions, response, US FDA did not find them sufficient.
In its warning letter, US FDA also took note of similar cGMP violations cited in the June 2006 and September 2008 Warning Letters issued to other Ranbaxy Laboratories facilities.
It has become clear for US FDA that Ranbaxy’s attempts to make global corrections after past regulatory actions by the FDA have been inadequate, the agency stated.
In view of this, US FDA reminded that Ranbaxy is responsible for ensuring that all Ranbaxy drug manufacturing operations comply with applicable US requirements, including the CGMP regulations.
Earlier in September, US FDA issued warning letters to Ranbaxy’s factories in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh and had blocked the import of 30 generic drugs from these two facilities to the United States.
US FDA conducted an inspection in Ranbaxy’s Paonta Sahib facility in Himachal Pradesh during 2008. Following these findings, the regulator has decided to revoke licences of 25 products made in this factory, FDA also stopped a number of application from this facility pending approval.
The US drug regulator which hauled up India’s leading generic maker for repeatedly violating manufacturing norms since atleast 2006, found out 1,676 errors in the audit of 15 applications approved for the US market.
Following these findings, the regulator has decided to revoke licences of 25 products made in this factory. The number of application stopped from this facility pending approval included the 6-months’ exclusive marketing rights for Ranbaxy’s version of world’s largest selling anti-obesity drug Lipitor, a worldwide best-seller, which comes off patent in 2011.
Ranbaxy Laboratories Ltd,in which Japan’s Daiichi Sankyo owns about 64 percent, reported net loss of 7.78 billion rupees ($156 million) in its fiscal first quarter ended March 2009, compared with a profit of 1.03 billion rupees in the year-ago quarter, following the US FDA action.
The US market accounted for about a quarter of Ranbaxy’s $1.6-billion revenues for the year ended 2008.