USFDA issues 15 observations for Jubilant HollisterStier General Partnership Montreal facility
Noida: Jubilant Pharmova Limited has 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," the Company stated.
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.
Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through multiple manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.