Zydus Lifesciences hits 52-week high on getting USFDA’s final approval for Roflumilast Tablets

Today, the stock opened at Rs 519.70 and touched a high and low of Rs 519.70 and Rs 513.60, respectively. 

Approval from USFDA 

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg). 

Roflumilast reduces inflammation in the lungs which leads to chronic obstructive pulmonary disease (COPD). It is used to prevent the worsening of symptoms in people with severe COPD. The drug will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad, (India). 

Roflumilast Tablets, 250 mcg had annual sales of USD 34 million in the United States (IQVIA MAT February 2023). The group now has 363 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04. 

Stock price movement 

On Wednesday, the shares of Zydus Lifesciences closed at its 52-week high at Rs 517.30, up by 0.30% from its previous closing of Rs 515.75 on the BSE. The stock opened at Rs 519.70 and touched a high and low of Rs 519.70 and Rs 513.60, respectively. 

The BSE group 'A' stock of face value of Rs 1 touched a 52-week high and low of Rs 519.70 and Rs 319.40, respectively. Last one week high and low of the scrip stood at Rs 519.70 and Rs 499.50respectively. The current market cap of the company is Rs 52,361.32 crore. 

The promoters holding in the company stood at 74.98%, while Institutions and Non-Institutions held 17.02% and 8.00% respectively. 

Company Profile 

Zydus Lifesciences is one of the top five players in the domestic formulations market, and domestic sales formed 32% of consolidated revenue in fiscal 2022. The group is ranked among the top 3 players in the high-growth segments such as respiratory, pain management, gynaecology and dermatology, which account for about 11%, 10%, 6% and 5%, respectively, of its domestic formulation sales.