Now Reading: Pulse Pharma gets DCGI nod for nano vitamin D3 oral dispersion
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Pulse Pharma gets DCGI nod for nano vitamin D3 oral dispersion
Pulse Pharmaceuticals has received approval from the Drugs Controller General of India (DCGI) for its nano-carrier entrapped Vitamin D3 oral dispersion, the company announced on Thursday. Founder and Managing Director K. V.…
Pulse Pharmaceuticals has received approval from the Drugs Controller General of India (DCGI) for its nano-carrier entrapped Vitamin D3 oral dispersion, the company announced on Thursday. Founder and Managing Director K. V. Rambabu said the approval is likely the first in the world for a nanocarrier-based vitamin D3 product. The company already manufactures the product for pharma firms including Abbott and Sanofi for the Indian market, according to the Times of India.
The company said clinical studies showed the formulation delivered 50-60% higher serum vitamin D levels than conventional products. Pulse holds five patents across India, the U.S., Russia, Mexico and Australia, with an EU patent for its Aqueol platform in final approval stages. The company plans to use the DCGI nod to seek regulatory approvals in the U.S. and Europe, and to expand into South Asian, Southeast Asian, African and Middle Eastern markets.
Indian Opinion Analysis
Both The Hindu and the Times of India offer neutral, straight reporting with no discernible slant. Each leads with the DCGI approval and the company's claim of being a world first. The Times of India adds a concrete clinical performance figure (50-60% higher serum levels) and the existing manufacturing tie-ups with Abbott and Sanofi, which The Hindu omits. The Hindu, however, provides more detail on other nutrients and drugs in the pipeline. For a careful reader, the core news is the regulatory milestone and the patent portfolio. The key number to watch is the EU patent decision, which will signal the technology's global regulatory path.
The key number to watch is the EU patent decision, which will signal the technology's global regulatory path.
Coverage: 2 sources, 2 neutral
Sources (2): thehindu.com (neutral report), timesofindia.indiatimes.com (neutral report)
This story was synthesised by AI from the 2 sources linked above.
