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This pharma company's shares surged to a new 52-week high after receiving final approval from the USFDA.
Ashwin Urkude
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This pharma company's shares surged to a new 52-week high after receiving final approval from the USFDA.

The share has delivered over 95 per cent returns in the past year, transforming into a multi-bagger with over 260 per cent returns in the last two years.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules, 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza Capsules). Valbenazine Capsules are indicated for the treatment of adults with tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India.

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 40 mg, and 80 mg, and was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 60 mg. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Valbenazine Capsules, 40 mg, and 80 mg, and is eligible for 180 days of sole generic drug exclusivity for Valbenazine Capsules, 60 mg.

Valbenazine Capsules had annual sales of USD 1993.6 million in the United States (IQVIA MAT June 2024). The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is currently trading at Rs 1308.00, up by 28.45 points or 2.22 per cent from its previous closing of Rs 1279.55 on the BSE. The scrip opened at Rs 1296.15 and has touched a high and low of Rs 1323.90 and Rs 1283.95 respectively. So far 90674 shares were traded on the counter.

The BSE group 'A' stock of face value Rs 1 has touched a 52-week high of Rs 1323.90 on 9th Aug 2024 and a 52-week low of Rs 567.85 on 26th Oct 2023. Last one week high and low of the scrip stood at Rs 1323.90 and Rs 1218.25 respectively. The current market cap of the company is Rs 131132.41 crore. The promoters holding in the company stood at 74.98 per cent, while Institutions and Non-Institutions held 18.22 per cent and 6.79 per cent respectively.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. The company is one of the leading innovation-driven pharmaceutical companies in India with a presence across the pharmaceutical value chain of innovating (research & development), manufacturing, marketing, and selling of finished dosage human formulations (generics, branded generics, and specialty formulations, including biosimilars and vaccines), active pharmaceutical ingredients (APIs), animal healthcare products and consumer wellness products. Innovation is the backbone of the company as it ensures business sustainability through the continuous availability of new products for various businesses.

Disclaimer: The article is for informational purposes only and not an investment advice.

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