Jubilant Pharmova arm gets OAI status from USFDA for Montreal facility

The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.

Published On 2023-05-30 06:18 GMT   |   Update On 2023-05-30 06:18 GMT
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NoidaJubilant HollisterStier General Partnership (JHSGP), a wholly owned subsidiary of Jubilant Pharmova Limited has announced that it received a communication from the US Food and Drug Administration (USFDA) through which the latter intimated that pursuant to its February 2023 audit of the Contract Manufacturing (CMO) facility at Montreal Canada, the US FDA has determined inspection classification of the facility as “Official Action Indicated”(OAI). 

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Official Action Indicated means regulatory and/or administrative actions will be recommended.

The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.

"The Company is engaging closely with the USFDA and is committed to address the observations within the stipulated time," the company stated.

Read also: Jubilant announces additional loan facility by Government of Canada for expansion of its CMO Montreal facility

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 five manufacturing facilities. The CRDMO segment (through Jubilant Biosys) provides collaborative research and partnership for Drug Discovery through two 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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