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Sun’s Halol Site Out Of Compliance Rut, Could Add Some SPARC Too

Executive Summary

Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.

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Sun Site Stares At FDA Action But Dent May Be Limited

FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.

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