MoneyWorks4Me

Biocon’s arm gets USFDA nod for ANDA of Everolimus Tablets

12 Jan 2026 Evaluate

Biocon’s wholly owned subsidiary -- Biocon Pharma has secured approval from the U.S. Food and Drug Administration (USFDA) for its ANDA for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths. Everolimus Tablets for Oral Suspension are indicated for the treatment of adult and pediatric patients aged 1 year and older with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA) and for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. The approval will further strengthen the company’s portfolio of vertically integrated drug products.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

Peers
Company Name CMP
Sun Pharma. Inds. 1842.00
Dr. Reddys Labs. 1161.00
Cipla 1365.00
Lupin 2096.00
Zydus Lifesciences 1119.50
View more..