Zydus Life gets final USFDA approval for Topiramate extended-release capsules

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate extended-release capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (USRLD: Qudexy XR extended-release capsules).

Topiramate extended-release capsule is indicated to prevent and control seizures in people with epilepsy. It may also be used to prevent migraine headaches.

Topiramate extended-release capsule had annual sales of $68.8 million in the United States according to IQVIA data (IQVIA MAT Sep 2022).

The group now has 335 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare Limited) 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 on 7.6% rise in revenue from operations to Rs 3942.60 crore in Q2 FY23 over Q2 FY22.

Shares of Zydus Lifesciences rose 1% to Rs 409.45 on Wednesday, 30 November 2022.

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