Sun down on latest Indian US FDA import alert

The facility in Karkhadi, Gujarat produces cephalosporins, a class of β-lactam antibiotics, but in a filing with the Bombay Stock Exchange this morning Sun Pharmaceutical Industries announced the unit had been placed under an import alert by the US Food and Drug Administration (FDA).

The alert​ was issued following an inspection when the US agency identified some non-compliance of current Good Manufacturing Practice (cGMP) regulations, and thus drugs made from the facility may be detained without physical examination “until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center.”​

Sun Pharma spokesperson Mira Desai told in-Pharmatechnologist.com the alert “has a negligible impact on company-wide revenues,”​ and would be unlikely to cause any shortages in the US.

Furthermore, she confirmed the firm has already initiated several corrective steps to address the observations made by the FDA but was unable to provide more details.

Shares in the firm fell by over 5% following the announcement.

Import Alert & India​

The news sees Sun Pharma join a growing list of high profile Indian drugmakers who have had products headed for the US banned due to GMP violations.

All four of Ranbaxy’s facilities in India are subject to the alert – the API plant in Toansa​ becoming the latest to fall under the ban in January - whilst two of Wockhardt facilities​ fell under the import ban last year.

The FDA has spoken at length about ensuring quality from Indian suppliers, and Commissioner Margaret Hamburg visited the country last month in part to address this issue. A Statement of Intent was signed pledging cooperation in ensuring compliance between the US and Indian authorities, and the FDA has also said it would up the number of inspectors in the country​.

This specific Import Alert (66-40) cites 33 facilities in India where product imports are banned from. However, whilst much recent emphasis has been on India, 31 facilities in China are also affected by the ban. The next largest country is Germany, with eight plants banned from exporting their drugs to the US.

An antibiotic producing facility run by Sun Pharma has been hit with an import alert from the US FDA in the latest blow for Indian drug exporters.

The facility in Karkhadi, Gujarat is dedicated to producing cephalosporins, a class of β-lactam antibiotics, but in a filing with the Bombay Stock Exchange this morning Sun Pharmaceutical Industries announced the unit had been placed under an import alert by the US Food and Drug Administration (FDA).

The alert​ was issued following an inspection of the plant when the agency identified some non-compliance of current Good Manufacturing Practice (cGMP) regulations, and thus drugs made from the facility may be detained without physical examination “until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center.”​

Sun Pharma spokesperson Mira Desai told in-Pharmatechnologist.com the alert “has a negligible impact on company-wide revenues,”​ and would be unlikely to cause any shortages in the US.

Furthermore, she confirmed the firm has already initiated several corrective steps to address the observations made by the FDA but was unable to provide more details.

Shares in the firm fell by over 5% following the announcement.

Import Alert & India​

The news sees Sun Pharma join a growing list of high profile Indian drugmakers who have had products headed for the US banned due to GMP violations.

All four of Ranbaxy’s facilities in India are subject to the alert – the API plant in Toansa​ becoming the latest to fall under the ban in January - whilst two of Wockhardt facilities​ fell under the import ban last year.

The FDA has spoken at length about ensuring quality from Indian suppliers, and Commissioner Margaret Hamburg visited the country last month in part to address this issue. A Statement of Intent was signed pledging cooperation in ensuring compliance between the US and Indian authorities, and the FDA has also said it would up the number of inspectors in the country​.

This specific Import Alert (66-40) cites 33 facilities in India where product imports are banned from. However, whilst much recent emphasis has been on India, 31 facilities in China are also affected by the ban. The next largest country is Germany, with eight plants banned from exporting their drugs to the US.