Zydus Life gets tentative USFDA approval for Levothyroxine Sodium injection

The drug maker said it has received tentative approval from the US drug regulator to market Levothyroxine Sodium injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial.

Levothyroxine Sodium injection, manufactured by Fresenius Kabi USA, LLC, is indicated for the treatment of myxedema coma. The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.

According to IQVIA data Levothyroxine Sodium injection had annual sales of $45.2 million in the United States.

As of 30th September 2022, the Zydus group had 334 approvals and filed over 431 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.

On consolidated basis, the company's net profit declined 82.6% to Rs 522.50 crore despite of 7.6% rise in revenue from operations to Rs 3942.60 crore in Q2 FY23 over Q2 FY22.

The scrip was down 0.47% at Rs 399.90 on the BSE.

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