Hot Pursuit     19-Apr-23
Zydus Life gets USFDA nod for Roflumilast tablets
The drug maker announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast tablets.
The product is reference listed drug of Daliresp tablets.

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).

According to IQVIA MAT February 2023 data, Roflumilast tablets, 250 mcg had annual sales of $34 million in the United States.

Meanwhile, the pharma company said that it received final approval from the United States Food and Drug Administration (USFDA) for the manufacture and marketing of Estradiol Transdermal System USP, 0.014 mg/day (weekly), which is used in the prevention of postmenopausal osteoporosis. The product is bioequivalent to the Menostar Transdermal System.

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.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

Shares of Zydus Lifesciences rose 0.13% to Rs 516.40 on the BSE.

Previous News
  Zydus Lifesciences consolidated net profit rises 30.64% in the June 2024 quarter
 ( Results - Announcements 09-Aug-24   13:48 )
  Indices trade higher; consumer durable shares rally
 ( Market Commentary - Mid-Session 22-Apr-24   13:37 )
  Zydus Life edges higher after launching OAB treatment drug Mirabegron in US
 ( Hot Pursuit - 22-Apr-24   09:25 )
  Zydus Life rises on USFDA nod for dyskinesia treatment drug
 ( Hot Pursuit - 28-Aug-24   09:57 )
  Zydus Life’s Ahmedabad facility gets EIR from USFDA
 ( Hot Pursuit - 01-Oct-24   12:13 )
  Zydus receives USFDA tentative approval for Edaravone Injection
 ( Corporate News - 14-Mar-24   13:51 )
  Zydus Life gets USFDA nod for Ivabradine tablets
 ( Hot Pursuit - 01-Dec-23   14:50 )
  Zydus receives USFDA tentative approval for Letermovir tablets
 ( Corporate News - 23-Mar-24   14:00 )
  Zydus Life gets tentative USFDA approval for Letermovir tablets
 ( Hot Pursuit - 23-Mar-24   14:21 )
  Zydus receives USFDA final approval for Chlorpromazine Hydrochloride Injection
 ( Corporate News - 14-Mar-24   12:24 )
  Zydus and Guardant Health sign co-marketing agreement to promote Guardant360® portfolio for precision oncology
 ( Corporate News - 02-Nov-23   13:03 )
Other Stories
  KRN Heat Exchanger makes stellar debut
  03-Oct-24   10:31
  Maruti Suzuki total sales rises to 1,84,727 units in Sep’24
  03-Oct-24   10:12
  Metal shares gain
  03-Oct-24   10:00
  Basic materials shares gain
  03-Oct-24   10:00
  Telecom shares rise
  03-Oct-24   10:00
  JSW Steel Ltd Spikes 1.87%
  03-Oct-24   09:30
  Eicher Motors Ltd Falls 3.14%, BSE Auto index Drops 2.14%
  03-Oct-24   09:30
  Adani Ports records 14% YoY growth in Sept'24 cargo volumes
  03-Oct-24   09:29
  NMDC iron ore production rises YoY to 3.04 MT in Sept'24
  03-Oct-24   08:38
  Tata Motors total sales drop 11% YoY in Sept’24
  01-Oct-24   15:33
Back Top