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Zydus Lifesciences jumps on getting USFDA’s final approval for Valbenazine Capsules

09 Aug 2024 Evaluate

Zydus Lifesciences is currently trading at Rs. 1308.00, up by 28.45 points or 2.22% 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 09-Aug-2024 and a 52 week low of Rs. 567.85 on 26-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%, while Institutions and Non-Institutions held 18.22% and 6.79% respectively.

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

Zydus Lifesciences Share Price

942.55 3.35 (0.36%)
17-Apr-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1675.20
Dr. Reddys Lab 1235.40
Cipla 1238.30
Zydus Lifesciences 942.55
Lupin 2324.25
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