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.
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.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.
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Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.
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Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.
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Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.
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South Korea’s Celltrion has doubled down on its efforts in further building its pipeline, eyeing a target of 22 commercialized products by 2030 while also aiming to submit INDs for 13 novel compounds.
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Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.