Withdraw nod for 28 drug applications of Ranbaxy: Sun Pharma to USFDA

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New Delhi: Drug major Sun Pharma on Tuesday said one of its subsidiaries has voluntarily requested the US health regulator to withdraw approval for 28 Abbreviated New Drug Applications belonging to Ranbaxy Laboratories.

In a Bombay Stock Exchange (BSE) filing, Sun Pharmaceutical Industries said: “One of the company’s wholly-owned subsidiaries has voluntarily requested the United States Food and Drug Administration (USFDA) to withdraw approval for 28 Abbreviated New Drug Applications (ANDAs)”.

It further said: “These older drug products belong to erstwhile Ranbaxy Laboratories and are not being marketed in the US since 2008.”

In April 2014, Sun Pharma had announced the acquisition of the troubled rival Ranbaxy in an all-stock transaction worth $4 billion. Shares of Sun Pharma were trading 0.15 % lower at Rs631.25 apiece on the BSE.