Bharat Serums and Vaccines Limited (BSVL) has received a US patent for one its novel formulation, Amphotericin B Emulsion, which is a novel formulation of Amphotericin B in emulsion formulation. All the excipeints used for this formulation are US FDA approved for injectable formulations.

Comparative tests in animals have shown this formulation to be many times safer than any of the existing Amphotericin formulations. Amphotericin B has been considered to be the gold standard in the treatment of fungal infections. However, Amphotericin is highly nephrotoxic, which limits the usage of the drug. Despite introduction of newer antifungal formulations into the market, there continues to be an interest in Amphotericin formulations primarily due to the fact that over a period of time, the fungi build resistance to the anti fungal agents.

BSVL has already received the marketing permission for this drug in India for Visceral Leishmaniasis and is in process of conducting clinical trials for obtaining the permission in treatment of fungal infections. BSV has also conducted a pre IND meeting with the US FDA for the clinical path and is in process of filing the IND by Quarter I 2006.

The present anti fungal market is in excess of USD 2.0 billion out of which the various Amphotericin formulation have a market share of in excess of USD 300 million. BSVL expects that a safer Amphotericin formulation would be in a position to capture a substantial share of the global anti fungal market.