Manufacturing Compliance Woes Wilt Glenmark
An FDA audit flagged up compliance deviations at Glenmark’s manufacturing facility in Baddi, piling up pressure on the firm in an already challenging business environment that saw it report subdued Q2 earnings.
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Glenmark, which has been the recipient of a string of notices from the US Food and Drug Administration over manufacturing quality issues, is again under fire with the regulator blasting the leading Indian drugmaker for failing to ensure “consistent production” of safe and effective products.
Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.
After a weak second quarter, Lupin had a nasty surprise with the FDA issuing a combined warning letter for two of its Indian manufacturing sites. The FDA action is expected to setback US product approvals, though Lupin maintained that its “structural story of growth” remained intact.