Shilpa Medicare Ltd. has announced that the Subject Expert Committee (Haematology) has approved the company to conduct Phase III clinical trials for its Recombinant Human Albumin (rHA) 20%. This approval follows the successful completion of Phase I trials, as previously reported on August 7, 2024.
The Phase III studies will proceed based on the protocol sanctioned by the committee. Shilpa Medicare is the first Indian company to receive such approval, marking a significant milestone in addressing the global demand and supply challenges associated with human serum albumin.
Human serum albumin is essential in medical treatments for restoring blood volume and replacing lost fluids in cases such as accidents, severe burns, fatal erythroblastosis, hypoproteinemia, and surgeries. However, its supply is limited due to reliance on whole blood or donated human plasma. Shilpa’s rHA, derived from yeast, offers a highly purified alternative that is structurally and functionally equivalent to human serum albumin.
Shilpa Medicare is an integrated pharmaceutical group specializing in niche oncology and non-oncology APIs, peptides, polymers, and differentiated finished dosage formulations, including orally dispersible films and transdermal patches. The company also provides end-to-end contract development and manufacturing organization (CDMO) services to global pharmaceutical companies, supported by four R&D units and seven manufacturing facilities.
This advancement underscores Shilpa Medicare’s commitment to innovation and its role in enhancing healthcare solutions on a global scale.
