FDA lifts bar for Sun at its key Halol plant
Sun Pharma can finally begin to receive US Food and Drug Administration (FDA) approvals for new products from its key Halol formulations manufacturing facility in Gujarat, India, after successfully addressing all issues in a longstanding warning.
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Sun Pharma’s Halol facility has been placed under an import alert by the FDA following an inspection earlier this year that uncovered GMP deficiencies.
An FDA warning letter issued to Aurobindo highlights recurring failures over several sites, while Teva is setting up a biologics development campus in the US and Nexus is investing in sterile injectables capacity.
Sun’s MD Dilip Shanghvi made the rather frank admission during the firm’s third-quarter earnings call, maintaining that generics is nevertheless an “interesting” business for the Indian major. In light of this outlook, Sun has continued its policy of withdrawing what it feels are “unviable” ANDAs from under FDA review.