Zydus Lifesciences receives USFDA approval and announces manufacturing partnership

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for its Estradiol and Levonorgestrel Transdermal System. This generic version of the Climara Pro® system is intended to treat moderate to severe menopause symptoms and prevent osteoporosis in postmenopausal women. The approval includes a 180-day exclusivity period under the Competitive Generic Therapy (CGT) pathway, which is expected to strengthen the company’s position in the US market.

Separately, Zylidac Bio, a biologics CDMO within the Zydus Lifesciences group, has entered a partnership with Prolific Machines to scale advanced biologics manufacturing. The collaboration aims to integrate Prolific’s light-based technology, which uses optogenetics to control protein expression, into Zylidac’s production processes. The partnership will focus on scaling technology from 50-liter development stages to 250-liter and full GMP manufacturing scales to support the production of complex proteins and monoclonal antibodies.