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With Seroquel Generic Approval, Is Aurobindo Close To Getting Off The FDA Hook?

 
• By Vikas Dandekar

India’s Aurobindo Pharma lands U.S. FDA approval of generic Seroquel despite warning letter issued last year.

MUMBAI – When Aurobindo Pharma Ltd. announced U.S. FDA approval for its generic versions of Seroquel (quetiapine) in multiple strengths late on March 28, analysts were excited as the drug’s patent expiry opened up a large revenue potential for the generics industry with sales crossing $4.5 billion annually.

But more intriguing is the fact that the product used for the treatment of schizophrenia and bipolar disorders had been approved out of Unit III, Aurobindo’s site that had been...

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More from India

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Pharma Women’s Workforce In India: Weak Start, Promotions, C-Suite Drop Off

 
• By Anju Ghangurde

McKinsey senior partner Vivek Pandit talks to Scrip about some of the intricacies underlying the key findings of a study on pharma’s workforce gender gap in India. Women’s representation starts low at entry level, peaks at senior manager positions and falls off again for C-suite roles, this found.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

 
• By Vibha Ravi

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By Vibha Ravi

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.

More from Focus On Asia

Pharma Women’s Workforce In India: Weak Start, Promotions, C-Suite Drop Off

 
• By Anju Ghangurde

McKinsey senior partner Vivek Pandit talks to Scrip about some of the intricacies underlying the key findings of a study on pharma’s workforce gender gap in India. Women’s representation starts low at entry level, peaks at senior manager positions and falls off again for C-suite roles, this found.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

 
• By Vibha Ravi

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

Japan Pharma Sees US Revenues Grow But Policy Impact Still Unclear

 
• By Lisa Takagi

Japanese majors put in generally solid performances in the fiscal year ended 31 March, but overseas revenues and forex effects, rather than the domestic market, provided most of the growth.