Are Jubilant Pharmova’s US Plant Closure, FDA Observations At Canada Unit A Concern?

Lupin Continues Good Run With Agency

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits. Scrip takes a look at the likely impact.

Ups And Downs For Companies
US FDA's Inspections Have Long Impacted Indian Companies' Earnings • Source: Shutterstock

The US Food and Drug Administration (FDA) has had a significant influence on the direction Indian pharma companies’ revenues could head in a financial year given the dependence of these companies on North America and the role played by the agency as the geography’s gatekeeper.

For instance, Lupin Limited went through an extended winter phase when one or the other of its manufacturing units received either observations or a warning letter from the agency, rendering such

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