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Natco Doubles Down On US With Ambitious ANDA Plan

 
• By Penelope MacRae

One of India’s leading generic players, Natco Pharma, aims to file at least 10 ANDAs in the US in the next two years to expand its footprint in this key market as more medicines fall off the patent cliff, and analysts say the company - which is also considering new therapeutic areas - could be on the “verge of a breakout” in its US business.

India

Natco Pharma Ltd. made global headlines four years ago when India’s patent authority gave the mid-sized firm a compulsory license to produce a generic version of Bayer AG’s cancer drug Nexavar (sorafenib) at a price 97% below the patent-protected original.

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More from India

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Enzene Sees Tariff Exemptions For India, Front-Ends US Capacity

 
• By Vibha Ravi

Enzene's CEO Himanshu Gadgil anticipates exemptions for Indian products from US tariffs expected to be imposed on pharmaceuticals. In an interview ahead of the US Vice Premier's India visit, he also talks about front-loading capacity at Enzene's US plant and a change in its biosimilars strategy

US Tariffs And Manufacturing Concentration: Double-Edged Sword?

 
• By Anju Ghangurde

India and the US are the major manufacturers of finished dosages for the US market in terms of volume (China accounts for 9% of injectables), though the US relies heavily on India for solid oral dosage forms and specific generics, including lenalidomide and albuterol. Scrip talks to experts on some of the key implications of geographic concentration of production for the US market amid the specter of tariffs.

More from Focus On Asia

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 
• By Dexter Jie Yan

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.

Novotech CEO On Flexible Trial Solutions Amid Tariff, Geopolitical Tensions

 
• By Anju Ghangurde

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.