Hot Pursuit     17-Nov-21
Alembic Pharma JV gets USFDA nod for antibacterial ointment
Alembic Pharmaceuticals said that its joint venture (JV) Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its ANDA for Mupirocin Cream USP, 2%.

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham (Cork), Ireland.

Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions due to susceptible . strains of S. aureus and S. pyogenes.

Mupirocin Cream USP, 2% has an estimated market size of US$ 28 million for twelve months ending Jun 2021 according to IQVIA.

Aleor has been granted a competitive generic therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved applicant.

Alembic has received year to date (YTD) 13 approvals (10 final approvals and 3 tentative approvals) and a cumulative total of 152 ANDA approvals (133 final approvals and 19 tentative approvals) from USFDA.

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

The drug maker's consolidated net profit dropped 49.22% to Rs 169.29 crore on a 11.31% fall in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.

The scrip rose 0.19% to currently trade at Rs 788.25 on the BSE.

Previous News
  Alembic Pharma Q1 PAT rises 12% YoY to Rs 135 cr
 ( Hot Pursuit - 08-Aug-24   15:48 )
  Alembic Pharma gets USFDA nod for Paliperidone extended-release Tablets
 ( Hot Pursuit - 27-Sep-24   13:40 )
  Alembic Pharma gets US FDA nod for anticoagulant Dabigatran
 ( Hot Pursuit - 13-Aug-24   13:46 )
  Alembic Pharmaceuticals consolidated net profit rises 596.17% in the March 2023 quarter
 ( Results - Announcements 05-May-23   17:32 )
  Alembic Pharma rises after receiving USFDA nod for cancer drug
 ( Hot Pursuit - 04-Jul-24   13:00 )
  Volumes soar at Lemon Tree Hotels Ltd counter
 ( Hot Pursuit - 02-Jan-24   11:00 )
  Alembic Pharma Q4 PAT zooms to Rs 153 cr; R&D spend at Rs 136 crore
 ( Hot Pursuit - 06-May-23   14:44 )
  Alembic Pharma gains on USFDA nod for Fluorouracil injection
 ( Hot Pursuit - 06-Mar-23   11:13 )
  Alembic Pharmaceuticals gains on USFDA nod for bronchoconstriction drug
 ( Hot Pursuit - 11-May-22   12:22 )
  Alembic Pharma receives USFDA approval for Dabigatran Etexilate Capsules
 ( Corporate News - 13-Aug-24   12:15 )
  Alembic Pharmaceuticals gets USFDA approval
 ( Corporate News - 27-Oct-22   11:52 )
Other Stories
  Tata Motors total sales drop 11% YoY in Sept’24
  01-Oct-24   15:33
  Vipul Organics hits all-time high after board OKs Rs 25 cr right issue
  01-Oct-24   15:06
  Magellanic Cloud Ltd leads losers in 'A' group
  01-Oct-24   15:00
  Kamdhenu Ventures Ltd leads losers in 'B' group
  01-Oct-24   14:45
  GE Power India rises on bagging order worth Rs 240-cr
  01-Oct-24   14:41
  Volumes jump at Caplin Point Laboratories Ltd counter
  01-Oct-24   14:30
  TVS Motor registers 20% growth in September 2024 sales; Q2 total sales at 12.28 lakh units
  01-Oct-24   14:07
  Oil and Gas shares slide
  01-Oct-24   14:00
  Telecom shares fall
  01-Oct-24   14:00
  Real Estate stocks slide
  01-Oct-24   14:00
Back Top