Sun Pharmaceutical Industries Limited has informed the Exchange regarding a press release dated May 16, 2025
SUNPHARMA · price
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Sun Pharma announced that the US FDA has granted premarket approval (PMA) for the next generation LED-based BLU-U® Blue Light Photodynamic Therapy Illuminator, used in combination with LEVULAN® KERASTICK® for treating actinic keratosis (AK) on the face, scalp, or upper extremities. The new Model 4170E is more compact, lighter, and features updated LED panels replacing the older fluorescent tubes, while maintaining the same safety and efficacy. The approval was granted under the FDA's Real-Time Review Program, and the device will be available for delivery in the near future through Sun Pharma's specialty dermatology channel.
This strengthens Sun Pharma's specialty dermatology portfolio in the US, supporting its high-margin specialty business (which accounts for over 18% of company sales). Positive for the company's US growth story, though the financial impact is likely modest given it's a product upgrade rather than a new therapy.