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Zydus Lifesciences (Zydus) today announced that the United States Food and Drug Administration (USFDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day. (URLD: Climara Pro® Transdermal System 0.045 mg/0.015 mg per day).
The ANDA has been designated by the USFDA as a Competitive Generic Therapy (CGT). The product is eligible for the 180-day exclusivity period available to certain first approved applicants under the CGT pathway, subject to the provisions of the U.S. Federal Food, Drug, and Cosmetic Act. Any exclusivity period, where applicable, would commence upon first commercial marketing of the product.
Estradiol and Levonorgestrel Transdermal System is primarily used treat moderate to severe symptoms of menopause. It is also used in postmenopausal women for prevention of osteoporosis. The product will be manufactured at the group's manufacturing plant at Moraiya, near Ahmedabad, Gujarat.
Zylidac Bio, a fully integrated biologics CDMO within the Zydus Lifesciences (Zydus) group, and Prolific Machines, a biotechnology company advancing biologics development and manufacturing through integrated optogenetics-enabled solutions delivering breakthrough yields, superior on-target quality, and precise process control, today announced a partnership to scale Prolific's platform from early development through GMP production. Both companies are headquartered in Emeryville in the San Francisco Bay Area.
Prolific's technology uses light to control protein expression in engineered cell lines, enabling substantial gains in productivity and product quality. The platform combines optogenetics enabled cell lines, illumination systems compatible with standard bioreactors, AI-driven process optimization, and advanced analytics. The technology is particularly useful for difficult-to express proteins including multi-specific antibodies, fusion proteins, cytokines and other complex modalities. Prolific has reported a record-breaking productivity milestone of 21 g/L in a 15-day intensified fed-batch CHO run for a monoclonal antibody (mAb) at small scale, along with up to three-fold titer increases for other complex formats.
Under the agreement, Zylidac Bio will first complete a tech transfer of Prolific's process at 50 liter scale to reproduce Prolific's results at the Zylidac site. The companies plan to subsequently scale client programs 250 liters, and into GMP manufacturing scale. Prolific's illumination hardware will work seamlessly with Zylidac's existing bioreactors, eliminating the need for customers to build new manufacturing infrastructure.
The partnership creates an end-to-end development and manufacturing pathway for Prolific's clients, spanning early development through commercial-scale supply. Programs can start with cell line development at Prolific and move seamlessly a short distance to Zylidac for scale-up, drug substance and drug product manufacturing, fill-finish, and packaging.
Zydus Sunshine Lifesciences, the proposed joint venture between Zydus Lifesciences (Zydus) and Sunshine Healthcare, part of Sunshine Holdings PLC, signed an agreement with the Board of Investment of Sri Lanka on 13 October 2026 to establish a pharmaceutical manufacturing facility in the BOI zone in Horana, Sri Lanka.
Both companies had announced the formation of a Joint Venture on 26 June 2026. The project envisages a phased investment of over USD 20 million. The facility will be developed on a site of nearly four acres, with commercial operations expected to commence in 2028, subject to project timelines and relevant regulatory approvals.
In its first phase, the facility will manufacture oral solid dosage forms for the Sri Lankan market. The investment supports the Zydus' international presence and commitment to expanding access to quality medicines. Local manufacturing is expected to strengthen medicine supply chain resilience and support the availability of essential medicines in Sri Lanka.
Zydus Lifesciences and Formycon AG (Formycon), an independent developer of biosimilars, today jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda®1 (pembrolizumab).
To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of an application for a Keytruda® biosimilar.
The BLA was submitted in the third quarter of 2026. Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027. The regulatory dossier for FYB206 has also been submitted to Health Canada.
Zydus Lifesciences Ltd rose for a fifth straight session today. The stock is quoting at Rs 1168, up 0.6% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is down around 0.29% on the day, quoting at 23345.95. The Sensex is at 74600.56, down 0.35%. Zydus Lifesciences Ltd has added around 5.82% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has added around 2.24% in last one month and is currently quoting at 27021.15, down 0.34% on the day. The volume in the stock stood at 10.16 lakh shares today, compared to the daily average of 13.26 lakh shares in last one month.
The benchmark September futures contract for the stock is quoting at Rs 1172, up 0.49% on the day. Zydus Lifesciences Ltd is up 11.79% in last one year as compared to a 7.25% fall in NIFTY and a 20.76% fall in the Nifty Pharma index.
The PE of the stock is 31.79 based on TTM earnings ending June 26.
Zydus Lifesciences Ltd is up for a third straight session today. The stock is quoting at Rs 1154.5, up 1.71% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.24% on the day, quoting at 23325.6. The Sensex is at 74505.4, up 0.26%. Zydus Lifesciences Ltd has gained around 4.53% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has gained around 1.14% in last one month and is currently quoting at 26579.25, up 0.13% on the day. The volume in the stock stood at 14.78 lakh shares today, compared to the daily average of 12.44 lakh shares in last one month.
The benchmark September futures contract for the stock is quoting at Rs 1158.9, up 1.74% on the day. Zydus Lifesciences Ltd is up 11.3% in last one year as compared to a 7.9% slide in NIFTY and a 17.31% slide in the Nifty Pharma index.
The PE of the stock is 31.13 based on TTM earnings ending June 26.
Zydus today announced positive topline results from its completed EVIDENCES-X™ Phase II(b), prospective, multicentre, randomized, double-blind, placebo controlled clinical trial evaluating the efficacy and safety of Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis.
The liver biopsy-driven EVIDENCES-X™ study enrolled 189 subjects who were randomized in a 1:1:1 ratio to receive Saroglitazar 2 mg, Saroglitazar 4 mg or placebo over a treatment period of 52 weeks. The study successfully met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52 with the treatment difference of 26.5%. In addition to achieving the primary endpoint, the study demonstrated encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology parameters, steatosis, inflammation and ballooning assessments. Further details would be presented in the upcoming Liver Congress.
The EVIDENCES-X™ trial was led by Prof. Naga Chalasani, M.D., Interim Chair, Department of Medicine, Indiana University School of Medicine, and Prof. Arun J. Sanyal, M.D., Division of Gastroenterology, Virginia Commonwealth University, as co-Principal Investigators.
Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) and MASH, continue to represent significant unmet medical needs globally. Experts estimate that approximately 25% of adults worldwide are affected by MASLD, while MASH affects an estimated 5% to 20% of the adult population. MASH is characterized by hepatic steatosis, inflammation, and hepatocellular injury and can progress to advanced fibrosis, cirrhosis, liver failure, liver cancer, and death.