Drug Approval | November 24, 2025
Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The company will soon be launching a new portfolio of products in this segment
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
The partnership will enable rapid and reliable product delivery
The licence covers Actimed’s existing patents, its proprietary know-how and any future related patents, giving Mankind full control to advance the products under its own brands
The issue comprises a fresh issue of Rs. 95 crore and targeting a total raise of around Rs. 895 crore
Both companies will jointly execute development and scale-up of multiple strategic APIs, including late-stage NCE-1 opportunities
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