In the latest blow for India’s pharmaceutical sector, the US Food and Drug Administration (US FDA) has banned products manufactured at Sun Pharmaceutical Industries’ Karkhadi facility in Gujarat from entering the US.
The regulator, according to an announcement on its website dated March 12, listed the facility on its ‘red list’ which implies the drugs from the facility will be detained without physical examination as the company has not met the standards laid down in the US FDA’s current Good Manufacturing Practices (cGMP) rules.
The company’s Karkhadi facility manufactures antibiotics and active pharmaceutical ingredients (APIs). Sun Pharma has 10 manufacturing sites in India.
Commenting on the development, Sun Pharma, in a statement, said, “The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the US FDA.”
It added that the contribution of the plant, which makes antibiotic cephalosporin, to its consolidated revenue is negligible. “Sun Pharma has a negligible presence in the cephalosporin market with just one key product, cephalexin,” HSBC analyst Girish Bakhru wrote in a note.
“We therefore do not see any material impact in terms of sales and profitability,” Bakhru added. He estimated the net impact on FY15 earnings to be less than two per cent.
ENS Economic Bureau | Mumbai
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