Corporate News     19-Apr-23
Zydus receives USFDA approval for Roflumilast Tablets
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 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).

Previous News
  Zydus Life Matoda facility receives two observations from USFDA after inspection
 ( Hot Pursuit - 19-Jun-25   09:50 )
  Zydus Life subsidiary ZHL appoints Swati Dalal as MD
 ( Hot Pursuit - 16-Jun-25   14:42 )
  Zydus Lifesciences appoints Managing Director
 ( Corporate News - 16-Jun-25   14:16 )
  Zydus' Ankleshwar API unit clears USFDA inspection
 ( Corporate News - 12-Jun-25   10:41 )
  Zydus Life receives USFDA EIR for Gujarat facility
 ( Hot Pursuit - 12-Jun-25   09:55 )
  Zydus Life receives USFDA EIR for Dabhasa API facility
 ( Hot Pursuit - 10-Jun-25   15:19 )
  Zydus receives EIR for the API manufacturing facility at Dabhasa
 ( Corporate News - 10-Jun-25   14:11 )
  Zydus Lifesciences Ltd spurts 0.24%, up for fifth straight session
 ( Hot Pursuit - 10-Jun-25   13:00 )
  Stock Alert: Yes Bank, Zydus Lifesciences, Ashok Leyland, R Systems Intl
 ( Market Commentary - Stock Alert 04-Jun-25   08:05 )
  Zydus Lifesciences gets USFDA nod for Rifaximin tablets
 ( Hot Pursuit - 02-Jun-25   10:47 )
  Zydus Lifesciences receives USFDA tentative approval for Rifaximin Tablets
 ( Corporate News - 02-Jun-25   09:12 )
Other Stories
  Wipro allots 1.70 lakh equity shares under ESOP
  09-Jul-25   18:19
  Bharti Airtel incorporates step-down wholly owned subsidiary - Airtel Money
  09-Jul-25   17:56
  Asian Paints sells 4.42% stake in Akzo Nobel India in block deal
  09-Jul-25   17:30
  ACC commissions 1.5 MTPA brownfield grinding unit at Sindri Plant
  09-Jul-25   17:19
  Granules India extends corporate guarantee for Senn Chemicals A.G.
  09-Jul-25   16:31
  Welspun Corp schedules AGM
  09-Jul-25   16:29
  Pecos Hotels & Pubs AGM scheduled
  09-Jul-25   16:29
  Board of Pecos Hotels & Pubs recommends final dividend
  09-Jul-25   16:29
  Intellect implements eMACH.ai Digital Engagement Platform at Faisal Islamic Bank of Egypt
  09-Jul-25   16:29
  Delphi World Money to hold AGM
  09-Jul-25   16:28
Back Top