Shilpa Medicare gets CDSCO panel nod to conduct Phase III clinical trials for Recombinant Human Albumin 20%
New Delhi: In relation to the successful completion of Phase I clinical trials, Shilpa Medicare Ltd has announced that the Subject Expert Committee (Haematology)(SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has provided approval to conduct Phase III clinical trials for Recombinant Human Albumin (rHA) 20%.
"Shilpa Medicare Ltd announces that the results of its Phase I clinical trials were accepted by Subject Expert Committee (Haematology) (SEC) which has now provided approval to conduct Phase III clinical trials for Recombinant Human Albumin (rHA) 20%," the Company stated in a BSE filing.
The studies will be conducted based on the approved protocol by SEC. Shilpa is the first company in India to receive the approval for conducting Phase III clinical trials, claims the Company.
This approval clears regulatory strategy for India and various emerging markets that accept Indian studies and is an important step towards providing a reliable and safe alternative to human serum albumin, addressing the global demand and supply challenges.
Albumin is in high demand for various medical treatments, including restoring blood volume and replacing lost fluids during accidents, serious burn injuries, fatal erythroblastosis, hypoproteinemia, and surgeries. However, the supply of human serum albumin is limited due to the reliance on whole blood or donated human plasma. Shilpa’s Recombinant Human Albumin 20% (rHA), derived from yeast, offers a highly purified, structurally and functionally equivalent alternative to human serum albumin.
Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its strong R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.
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