Zydus Life gets USFDA nod for Sirolimus tablets

The drug maker said that it received final approval from US Food and Drug Administration for Sirolimus tablets, 1 mg and 2 mg.

The said drug is equivalent to reference listed drug, Rapamune tablets. It will be manufactured at the group's formulation manufacturing facility at Moraiya.

Rapamune is used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. It is also given to treat a rare lung disorder called lymphangioleiomyomatosis which predominantly affects women of childbearing age.

According to IQVIA MAT sales data for the 12-month period ending December 2022, Sirolimus tablets had annual sales of $69 million in United States.

As of 31 December 2022, the Zydus Group had 342 approvals and filed over 440 abbreviated new drug application (ANDAs) since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is engaged in an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The product portfolio of the company includes active pharmaceutical ingredients [API] and human formulations.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

The scrip declined 0.47% to Rs 475 on the BSE.

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