Shilpa Medicare Secures Phase III Trial Nod for Recombinant Albumin

26 Nov 2024 , 07:49 PM

Shilpa Medicare has received approval from the Subject Expert Committee (Haematology) to conduct Phase III clinical trials for its Recombinant Human Albumin (rHA) 20%.

The rHA 20% product, derived from yeast, is a highly purified alternative to human serum albumin, matching it structurally and functionally.

Albumin is essential for various medical uses, such as:

• Restoring blood volume in accidents and severe burn injuries.
• Treating hypoproteinemia and fatal erythroblastosis.
• Replacing fluids during surgeries.

Human serum albumin supply is limited due to its dependency on donated human plasma or whole blood, highlighting the importance of Shilpa Medicare’s development.  Shilpa Medicare is the first Indian company to gain approval for Phase III trials of Recombinant Human Albumin.

Separately, Shilpa Pharma Lifesciences, a subsidiary of Shilpa Medicare, secured a Certificate of Suitability (CEP) for Nifedipine from the European Directorate for the Quality of Medicines & Healthcare (EDQM). Nifedipine is an antihypertensive and anti-anginal drug, categorized as a calcium-channel blocker in the dihydropyridine subclass