Hyderabad's Pulse Pharma Secures DCGI Nod for Nano Vitamin D3 Delivery Platform

Hyderabad-based nano pharmaceutical drug delivery company Pulse Pharmaceuticals announced on Thursday that it has received regulatory approval from the Drugs Controller General of India (DCGI) for its nano-carrier entrapped vitamin D3 oral dispersion delivery platform.

The regulatory clearance marks a significant milestone in transitioning nano drug-delivery research into a commercially viable, patient-ready product. According to the company, the approval was granted following a stringent scientific evaluation and may represent the first regulatory clearance globally for a nanocarrier-based vitamin D3 delivery system.

The technology is designed to improve bioavailability, tolerability, and convenience for patients. Pulse Pharmaceuticals has already been utilizing this nano-delivery platform to manufacture products for major pharmaceutical companies, including Abbott and Sanofi, for the Indian market.

KV Rambabu, founder and managing director of Pulse Pharmaceuticals, noted that the DCGI approval highlights India's expanding contribution to pharmaceutical innovation for patients worldwide. He stated that the domestic clearance now clears the path for the Hyderabad company to pursue regulatory approvals in major international markets, including highly regulated regions such as the United States and Europe.

Beyond vitamin D3, Pulse Pharmaceuticals is actively working on applying its nano drug-delivery platforms to other essential nutrients and common medications. The pipeline includes formulations for nutrients such as iron, vitamin B12, and vitamin K2-7, as well as widely used medicines including paracetamol, diclofenac, and ibuprofen.