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Drugmaker Sun Pharmaceutical Industries has “voluntarily requested” the United States Food and Drug Administration to withdraw approvals given to 28 Abbreviated New Drug Applications (ANDAs).
“These older drug products belong to erstwhile Ranbaxy Laboratories Ltd and are not being marketed in the US since 2008,” the Mumbai-based company said of its action effected through one of its wholly-owned subsidiaries. The company did not, however, give details on the product approvals being withdrawn.
Last march, Sun had completed its $4-billion merger of Ranbaxy, a move that catapulted Sun to pole position in the domestic pharmaceutical segment. This was followed by an integration process that saw Sun Pharma divest non-strategic businesses and manufacturing facilities. Its Ireland facility, for instance, was one such decision.
Sun continues to be in the process of resolving issues raised by the US regulator on its manufacturing facilities, including import bans on four plants that came in from Ranbaxy.
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