Bengaluru, January 12, 2026: Biocon Limited on Monday announced a key regulatory milestone in its global formulations business, as its wholly owned subsidiary Biocon Pharma Limited received approval from the U.S. Food and Drug Administration for Everolimus Tablets for Oral Suspension across multiple strengths.
The approval covers Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg dosages, marking a significant addition to Biocon’s growing portfolio of complex oral solid and specialty formulations for regulated markets.
Product Indication and Therapeutic Use
Everolimus Tablets for Oral Suspension are indicated for the treatment of adult and pediatric patients aged one year and above diagnosed with Tuberous Sclerosis Complex (TSC) who develop Subependymal Giant Cell Astrocytoma (SEGA), a rare type of brain tumour. The formulation is also approved for adjunctive treatment of partial-onset seizures associated with TSC in adult and pediatric patients aged two years and older.The oral suspension format is particularly relevant for pediatric and special-needs patient populations, where ease of administration and dosing flexibility are critical to treatment adherence.
Strategic Significance for Biocon
The latest approval strengthens Biocon’s vertically integrated pharmaceutical portfolio, spanning active pharmaceutical ingredients, complex formulations, and finished dosage products for global markets. It also reinforces the company’s positioning in oncology and rare disease therapies, segments that continue to see sustained demand and long-term growth opportunities.Biocon has been steadily expanding its presence in regulated markets through approvals of complex generics and differentiated dosage forms, leveraging its manufacturing scale, R&D capabilities, and global regulatory track record.
About the Company
Biocon Limited is a leading Indian biopharmaceutical company listed on the BSE and NSE, with operations spanning biosimilars, generics, and novel biologics. The company focuses on developing and commercialising high-quality, affordable medicines for chronic and life-threatening diseases, with a strong presence across regulated and emerging markets.Source:
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