Jubilant Pharmova Announces Completion Of USFDA Audit Of Solid Dosage Manufacturing Facility At Roorkee

Jubilant Pharmova Announces Completion Of USFDA Audit Of Solid Dosage Manufacturing Facility At Roorkee

The USFDA has issued 4 observations pursuant to the completion of audit. The company will submit an action plan on the observations.

FPJ Web DeskUpdated: Saturday, February 03, 2024, 11:49 AM IST
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Jubilant Pharmova Announces Completion Of USFDA Audit | Image: Jubilant Pharmova (Representative)

Jubilant Pharmova Limited announced that the United States Food and Drug Administration (USFDA) has concluded audit of the solid dosage formulations facility on February 2, 2024 at Roorkee site, India of Jubilant Generics Limited, a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited, the company announced through an exchange filing.

The USFDA has issued 4 observations pursuant to the completion of audit. The company will submit an action plan on the observations.

The company currently supplies only one product to US from Roorkee facility, that contributed less than one percent of Jubilant Pharmova’s 9M’FY24 revenues.

Jubilant Pharmova Limited shares

The shares of Jubilant Pharmova on Friday at 3:30pm IST closed at Rs 591.40, up by 2.56 per cent.

About Jubilant Pharma Limited

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 Nonsterile products and Generics (Solid Dosage Formulations) caters to major regulated markets (USA, EU and other geographies) through five manufacturing facilities.

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