Hot Pursuit     17-Jun-24
Alembic Pharma gets USFDA nod for Icatibant injection
Alembic Pharmaceuticals announced that it has received final approval from US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Icatibant injection, single-dose prefilled syringe.
The approved drug is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection of Takeda Pharmaceuticals U.S.A., Inc.

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. This is the first peptide product approval from the USFDA received by the company.

Alembic has a cumulative total of 205 ANDA approvals (177 final approvals and 28 tentative approvals) from USFDA.

According to IQVIA, Icatibant injection had an estimated market size of $112 million for twelve months ending March 2024.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.

The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.

The scrip rose 0.78% to end at Rs 890.10 on Friday, 14 June 2024. The stock market is closed today on occasion of Bakri-Id.

Previous News
  Alembic Pharmaceuticals consolidated net profit rises 596.17% in the March 2023 quarter
 ( Results - Announcements 05-May-23   17:32 )
  Alembic Pharma rises on USFDA nod for breast cancer drug
 ( Hot Pursuit - 01-Apr-24   13:52 )
  Volumes spurt at Blue Star Ltd counter
 ( Hot Pursuit - 20-Sep-23   14:30 )
  Alembic Pharmaceuticals to table results
 ( Corporate News - 22-Jul-23   11:01 )
  Alembic Pharmaceuticals receives USFDA approval for Acitretin Capsules
 ( Corporate News - 07-Aug-24   18:11 )
  Board of Alembic Pharmaceuticals recommends final dividend
 ( Corporate News - 06-May-23   09:20 )
  Alembic Pharma Q4 PAT zooms to Rs 153 cr; R&D spend at Rs 136 crore
 ( Hot Pursuit - 06-May-23   14:44 )
  Alembic Pharmaceuticals receives USFDA approval for Nifedipine Extended-Release Tablets
 ( Corporate News - 21-Nov-22   10:52 )
  Alembic Pharmaceuticals to convene board meeting
 ( Corporate News - 18-Jan-23   10:51 )
  Alembic Pharma gets USFDA nod for Nifedipine tablets
 ( Hot Pursuit - 21-Nov-22   11:14 )
  Alembic Pharma gets USFDA nod for Icatibant injection
 ( Hot Pursuit - 17-Jun-24   14:03 )
Other Stories
  Macrotech Developers pre-sales jumps 21% YoY in Q2 FY25
  05-Oct-24   09:04
  UCO Bank’s total advances jump 19% YoY in Q2 FY25
  04-Oct-24   15:15
  Vakrangee Ltd leads losers in 'A' group
  04-Oct-24   15:00
  Kamdhenu Ventures Ltd leads losers in 'B' group
  04-Oct-24   14:45
  GRSE bags Rs 226-cr LoA from West Bengal Govt
  04-Oct-24   14:40
  Volumes soar at Avenue Supermarts Ltd counter
  04-Oct-24   14:30
  Real Estate stocks edge lower
  04-Oct-24   14:00
  Auto stocks edge lower
  04-Oct-24   14:00
  Utilties stocks edge lower
  04-Oct-24   14:00
  HDFC Bank Ltd down for fifth straight session
  04-Oct-24   13:35
Back Top