Corporate News     12-Jun-24
Glenmark receives USFDA approval for Esomeprazole Magnesium Delayed-Release Capsules

Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent1 to Nexium®2 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon U.S. Holdings LLC. Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics Inc., USA.

According to Nielsen® syndicated data for the latest 52 weeks period ending 18 May 2024, the Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC) market achieved annual sales of approximately $259.2 million.

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace and 50 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Previous News
  Glenmark Pharmaceuticals launches TEVIMBRA® in India
 ( Corporate News - 24-Jun-25   10:53 )
  Nifty fails to hold 24,850 mark; media shares tumble
 ( Market Commentary - Mid-Session 18-Jun-25   11:36 )
  Glenmark pharma's US facility receives five observations after USFDA GMP inspection
 ( Hot Pursuit - 18-Jun-25   09:51 )
  Glenmark Pharmaceuticals Ltd soars 0.98%, rises for fifth straight session
 ( Hot Pursuit - 11-Jun-25   13:00 )
  Glenmark Pharma rises after zanubrutinib launch in India
 ( Hot Pursuit - 09-Jun-25   12:02 )
  Glenmark receives DCGI approval to launch oncology drug BRUKINSA in India
 ( Corporate News - 09-Jun-25   11:04 )
  Board of Glenmark Pharmaceuticals recommends final dividend
 ( Corporate News - 24-May-25   11:52 )
  Glenmark Pharmaceuticals reports consolidated net profit of Rs 4.65 crore in the March 2025 quarter
 ( Results - Announcements 24-May-25   07:44 )
  Glenmark Pharmaceuticals grants 1.19 lakh stock options under ESOS
 ( Corporate News - 22-May-25   16:03 )
  Glenmark Pharmaceuticals announces board meeting date
 ( Corporate News - 13-May-25   15:58 )
  Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001
 ( Corporate News - 05-May-25   19:16 )
Other Stories
  Vintage Coffee And Beverages to hold board meeting
  01-Jul-25   18:44
  Hind Rectifiers to convene AGM
  01-Jul-25   18:44
  Lupin carves-out its LupinLife Consumer Healthcare
  01-Jul-25   18:39
  Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel
  01-Jul-25   18:37
  LTIMindtree introduced its GCC-as-a-Service
  01-Jul-25   18:34
  Hyundai Motor India sells 60,924 units in June'25
  01-Jul-25   18:33
  Maruti Suzuki India records 6.26% decline in June sales
  01-Jul-25   18:30
  RateGain forges strategic partnership with Cloudbeds
  01-Jul-25   15:24
  Aurionpro Solutions announces strategic win with a leading UK-based financial institution
  01-Jul-25   15:17
  Tata Motors Q1 sales decline 8% to 2.10 lakh units
  01-Jul-25   15:08
Back Top