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.
Jubilant Pharmova Limited, formerly Jubilant Life Sciences Limited is engaged in Radiopharma, Allergy Immunotherapy, CDMO of Sterile Injectable, Generics, Contract Research Development and Manufacturing (CRDMO) and Proprietary Novel Drugs businesses. With a network of 46 radio-pharmacies in the US, Jubilant’s Radiopharma business is engaged in manufacturing and supply of Radiopharmaceutical products and services. Its other businesses such as Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Generics (Solid Dosage Formulations) caters to major regulated markets (USA, EU and other geographies) through multiple manufacturing facilities. The CRDMO segment (through Jubilant Biosys) provides collaborative research and partnership for Drug Discovery through two world-class research centers in India. The company is also involved in the manufacturing of Active Pharmaceutical Products (API) through a US FDA approved facility in Nanjangud, Karnataka. Jubilant Therapeutics (JTI) invested for in-house Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders.
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