Zydus Lifesciences Ltd.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes. Zydus’ generic Glatiramer Acetate Injection is an FDA-approved, AP-rated substitutable generics of Copaxone 20 mg/ml, 40 mg/ml and indicated for the treatment of relapsing forms of Multiple Sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 

Zydus’ generic Glatiramer Acetate Injection, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe. Glatiramer Acetate Injection had annual sales of $719 million in the United States (IQVIA MAT Mar2025). The group now has 426 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04. 

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.