USFDA4 Jun 2024, 09:38 pm
Shilpa Medicare's Subsidiary Files DMF for Patented Recombinant Human Albumin 20%
AI Summary
Shilpa Medicare Ltd. announces that its wholly owned subsidiary, Shilpa Biologicals Pvt Ltd, has filed a Type IV Drug Master File (DMF) with the USFDA for its patented, novel recombinant Human Albumin 20%. This environment-friendly, high-quality, and scalable product is designed to meet the growing demand for human serum albumin, addressing current and future market needs.
Key Highlights
- Shilpa Biologicals Pvt Ltd, a subsidiary of Shilpa Medicare Ltd, has filed a Type IV DMF with USFDA for recombinant Human Albumin 20%.
- The novel recombinant Human Albumin 20% process is patented, environment-friendly, and cost-competitive.
- The product is a high-quality, scalable solution designed to fulfill the growing demand for human serum albumin.
- This development is expected to help Shilpa Medicare address current and future market demands for human serum albumin.
- The announcement was made by Ritu Tiwary, Company Secretary & Compliance Officer of Shilpa Medicare Ltd.