Zydus Lifesciences Ltd

Zylidac Bio, a CDMO within the Zydus Lifesciences group, has partnered with Prolific Machines to scale Prolific's next-generation biologics manufacturing platform. This collaboration aims to transition Prolific's light-controlled cell line development technology from laboratory scale to Good Manufacturing Practice (GMP) production. The partnership will leverage Zylidac's Emeryville facility to scale Prolific's platform, which uses light to control protein expression, offering higher yields and improved quality for complex biologics. The initial phase involves tech transfer to a 50-liter scale, with plans to scale up to 250 liters and eventually to full GMP manufacturing. This integration provides an end-to-end development and manufacturing pathway for Prolific's clients, from cell line development to commercial supply.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day. This product, used for treating menopausal symptoms and preventing osteoporosis, is designated as a Competitive Generic Therapy (CGT) by the USFDA. Consequently, Zydus is eligible for a 180-day exclusivity period upon its first commercial marketing. The drug had annual sales of approximately USD 45.7 million in the US. The product will be manufactured at Zydus's facility in Moraiya, Gujarat. This approval adds to Zydus's portfolio, bringing their total USFDA ANDA approvals to 458.

Zydus Lifesciences Ltd has announced that its Board of Directors will convene on Wednesday, November 4, 2026. The primary agenda item for this meeting is the consideration and approval of the unaudited financial results for the quarter and half-year ended September 30, 2026. In compliance with SEBI regulations, the company has also informed about a trading window closure for directors and designated persons, which will be in effect until November 6, 2026, reopening on November 9, 2026.

Zydus Lifesciences Ltd has received an overall ESG rating of 71 for FY26 from NSE Sustainability Ratings and Analytics Limited (NSRAL), a SEBI registered ESG Rating Provider. The company has been categorized as a 'leader' in sustainability. This rating is unsolicited and based on publicly available data. The report was received on October 15, 2026. This disclosure is made in compliance with SEBI regulations.

Zydus Sunshine Lifesciences (Pvt) Ltd, a joint venture between Zydus Lifesciences Limited and Sunshine Healthcare (part of Sunshine Holdings PLC), has signed an agreement with the Board of Investment of Sri Lanka. The agreement is to establish a pharmaceutical manufacturing facility in the BOI zone in Horana, Sri Lanka. The project involves a phased investment exceeding USD 20 million and will be developed on nearly four acres. Commercial operations are anticipated to begin in 2028, pending project timelines and regulatory approvals. Initially, the facility will produce oral solid dosage forms for the Sri Lankan market. This investment aims to bolster Zydus' international presence, enhance access to quality medicines, and strengthen Sri Lanka's medicine supply chain resilience.

Zydus Lifesciences Ltd announced that the USFDA conducted an inspection of its manufacturing plant in Moraiya, Ahmedabad, from October 5th to October 13th, 2026. The inspection concluded with 5 observations. The company stated it will work closely with the USFDA to address these observations expeditiously. This disclosure is made pursuant to SEBI regulations.

Zydus Lifesciences and Formycon AG announced that the US Food and Drug Administration (USFDA) has accepted their Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda® (pembrolizumab). This marks the first publicly announced acceptance by the USFDA for a Keytruda® biosimilar. FYB206 was developed without a comparative Phase III efficacy trial, following a pathway agreed upon with the USFDA in early 2025. Zydus holds exclusive commercialization rights for the United States and Canada. The BLA was submitted in Q3 2026, with a decision expected in Q3 2027. The regulatory dossier has also been submitted to Health Canada. This development is significant for expanding access to affordable pembrolizumab therapy.

Zydus Lifesciences' subsidiary, Zydus Therapeutics, presented new post hoc analysis from its Phase 3 EPICS-III trial of saroglitazar for primary biliary cholangitis (PBC) at the ACG 2026 Annual Meeting. The analysis indicated a numerically higher biochemical response treatment difference with saroglitazar compared to placebo, particularly in U.S. subgroups. Specifically, U.S. patients showed a 60.7% response difference versus 41.6% in non-U.S. subgroups. These findings build on saroglitazar's clinical profile in PBC patients with inadequate response or intolerance to UDCA. Saroglitazar is currently under review by the FDA, with a planned U.S. launch by March 2027 if approved. The drug was generally well-tolerated in the trial.

Zydus Lifesciences Ltd., in partnership with MSN Laboratories Private Limited (MSN), has announced the launch of Riociguat Tablets in the United States. This marks the first generic version of Adempas® (riociguat) to be introduced in the U.S. market. The product, developed and manufactured by MSN, is approved by the USFDA in five strengths for treating pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). This first-to-market launch aims to provide a lower-cost alternative to U.S. patients. Bayer's Adempas® had global sales of approximately EUR 745 million (USD 850 million) in 2025.

Zydus Lifesciences Limited has announced an extension for the closing date of its joint venture with Sunshine Healthcare Lanka Limited and Zydus Sunshine Lifesciences (Private) Limited. The original agreement, dated June 26, 2026, involved Zydus subscribing to 50% of Zydus Sunshine's equity, forming a 50:50 joint venture. Both parties are still working to fulfill the condition precedents outlined in the Share Subscription and Shareholders' Agreement (SSSHA). Consequently, the closing date has been mutually extended, with the transaction now expected to be completed by December 2026. This extension was formalized through a letter executed on October 1, 2026.