01-12-2023 02:02 PM | Source: Accord Fintech
Zydus Lifesciences gains on getting USFDA`s final approval for Ivabradine Tablets

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Zydus Lifesciences is currently trading at Rs. 639.65, up by 1.80 points or 0.28% from its previous closing of Rs. 637.85 on the BSE.

The scrip opened at Rs. 640.00 and has touched a high and low of Rs. 648.70 and Rs. 639.65 respectively. So far 26027 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 668.50 on 10-Aug-2023 and a 52 week low of Rs. 401.05 on 19-Dec-2022.

Last one week high and low of the scrip stood at Rs. 648.70 and Rs. 628.05 respectively. The current market cap of the company is Rs. 64887.35 crore.

The promoters holding in the company stood at 74.98%, while Institutions and Non-Institutions held 17.95% and 7.07% respectively.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Ivabradine Tablets, 5 mg and 7.5 mg (USRLD: Corlanor Tablets, 5 mg and 7.5 mg). Ivabradine is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. It is also used in children aged 6 months and older for the treatment of stable symptomatic heart failure due to cardiomyopathy. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Ivabradine Tablets, 5 mg and 7.5 mg and therefore may be eligible for 180 days of shared generic exclusivity for Ivabradine Tablets, 5 mg and 7.5 mg. Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of $136.5 million in the United States (IQVIA MAT October, 2023). The group now has 382 approvals and has so far filed over 448 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.