Zydus Lifesciences Ltd. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levothyroxine Sodium injection in 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial in the American market.
Levothyroxine Sodium injection, used to treat myxedema coma or severe hypothyroidism, is manufactured by Fresenius Kabi USA, LLC.
Zydus Lifesciences, formerly known as Cadila Healthcare Ltd., will manufacture the drug at the group’s injectable facility at Jarod, in Vadodara, Gujarat.
According to IQVIA data, Levothyroxine Sodium injection had annual sales of $ 45.2 million in the US market for the 12-month period ending in September 2022.
Zydus Lifesciences now has 334 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.
The company posted an over 82 percent fall in its consolidated profit at Rs 522.7 crore for the September quarter compared to Rs 3,002 crore in the year-ago period. Its net sales rose to Rs 4134.7 crore from Rs 3,784.8 crore in the same period a year ago.
Zydus Lifesciences shares ended at Rs 400, down 0.52 percent.
(Edited by : Rukmani Krishna)
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