14 Oct 2026
The USFDA closed a 5-13 October inspection of Zydus Lifesciences' Moraiya plant in Ahmedabad with five observations.
The site's previous inspection in 2022 ended with four observations and a voluntary-action classification.
06 Oct 2026
Zydus Lifesciences and MSN launched the first US generic of Bayer's Adempas (riociguat) tablets in all five strengths.
MSN develops and makes the product. The release puts Bayer's global Adempas sales at about EUR 745 million in 2025.
28 Sep 2026
Zydus Lifesciences closed a USFDA inspection of its SEZ II plant at Ahmedabad with a single observation.
The cGMP inspection ran from 21 to 28 September and raised no data integrity observations. The company said it will work to address the one observation.
26 Sep 2026
Zydus Lifesciences cleared a USFDA inspection of its New Jersey pharmacovigilance office with nil observations.
The audit covered post-marketing surveillance for more than 500 products sold in the United States. It lands after warning letters at Baddi in June and at Jarod in 2024.
21 Aug 2026
Zydus received final USFDA approval for Ascorbic Acid Injection with 180-day competitive generic therapy exclusivity.
The reference product, Ascor Injection, recorded about $11.6 million of US sales in the twelve months to June 2026 on IQVIA data, so the direct revenue is modest. The CGT designation carries the value: the exclusivity period runs from first commercial marketing and holds off a second generic for six months. Manufacturing sits at the group's injectables plant at Jarod near Vadodara.
26 Jun 2026
Zydus Lifesciences formed a joint venture, Zydus Sunshine Lifesciences, to build a pharmaceutical plant in Sri Lanka, with the JV carrying investment of over 20 million dollars.
Zydus takes a 50 percent stake for up to 5 million dollars and the Horana plant will make drugs for Sri Lanka's retail market, giving it a local base in a neighbour looking to cut import dependence.
16 Jun 2026
Zydus Lifesciences completed its acquisition of US-listed Assertio Holdings through a 23.50 dollar per share cash tender, taking the company private and delisting it from Nasdaq.
The deal hands Zydus an established US specialty oncology platform anchored by ROLVEDON, used to prevent febrile neutropenia in cancer patients. About 66 percent of Assertio shares were tendered before the merger closed.
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