Zydus receives final approval from the USFDA for Roflumilast Tablets, 250 mcg

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") 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 that leads to chronic obstructive pulmonary disease (COPD). It is used to prevent 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 mn in the United States (IQVIA MAT Feb. 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.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 501.80 as compared to the previous close of Rs. 503.65. The total number of shares traded during the day was 105731 in over 3225 trades.

The stock hit an intraday high of Rs. 509.30 and intraday low of 500.35. The net turnover during the day was Rs. 53407183.00.

(*as of 31st December 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA FinalApproval RoflumilastTablets