Sun Pharma can finally begin to receive US Food and Drug Administration (FDA) approvals for new products from its key Halol formulations manufacturing facility in Gujarat, India, after successfully addressing all issues in a longstanding warning.
FDA lifts bar for Sun at its key Halol plant
Sun Pharma can finally begin to receive US Food and Drug Administration (FDA) approvals for new products from its key Halol formulations manufacturing facility in Gujarat, India, after successfully addressing all issues in a longstanding warning.
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Generics Bulletin previews the most noteworthy and anticipated events for May 2025.
During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.
News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.
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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As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
Amid several insights into its expectations of biosimilar competition in 2025, Roche has confirmed the total amount it anticipates being shaved from its top line this year.
Despite industry-wide uncertainty surrounding the Trump administration’s interest in pharma-focused tariffs, Hikma has maintained its guidance for the 2025 financial year.