Sun Hit As US FDA Raises Fresh Concerns Over Key Halol Plant
Indian generic giant Sun Pharma says the US FDA has flagged up new potential violations of good manufacturing practices at the company's key Halol factory, which exports a large number of products to the crucial US market and had been expected to overcome its past compliance problems.
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Public scrutiny has made 483 results much more impactful than intended, says Howard Sklamberg, former FDA deputy commissioner for global regulatory operations and policy. He reminds stakeholders that information in them is preliminary.
Further evidence of the impact of pricing pressure in the US was provided when Sun Pharma reported a sharp fall in profits in Q2 (although it beat the expectations of some analysts). Sun also expects a delay in EU approval for its late stage psoriasis asset, tildrakizumab, but US approval timelines appear unchanged, at least for now.