USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit
Drug Approval

USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations

  • By IPP Bureau | June 19, 2024

Jubilant Pharmova Limited ('Company') today announced that the United States Food and Drug Administration (USFDA) has concluded the audit of the Jubilant HollisterStier General Partnership (JHSGP)'s contract manufacturing facility located in Montreal, Canada.

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations.

JHSGP is a subsidiary of Jubilant HollisterStier Inc., USA, a step down subsidiary of Jubilant Pharma Limited, Singapore, and a wholly owned subsidiary of the Company.

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