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BIOCON

Pharma Secures Key USFDA Approval

's wholly owned subsidiary, Biocon Pharma, has received USFDA approval for its ANDA for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg, and 5 mg strengths. The drug is indicated for the treatment of Tuberous Sclerosis Complex (TSC)—including SEGA tumors and TSC-associated partial-onset seizures—across both adult and pediatric patients. This approval strengthens Biocon’s vertically integrated specialty and complex generics portfolio, reinforcing its presence in the regulated US market. Everolimus is a high-value, niche therapy requiring complex manufacturing capabilities, underscoring Biocon’s execution strength in difficult-to-make formulations. As India’s largest and Asia’s leading biotechnology company, Biocon continues to build a robust biopharmaceutical platform focused on affordable therapies for chronic and rare diseases, backed by innovation, scale, and global regulatory credibility. 📈 Complex generics | US market expansion | Portfolio deepening