Corporate News     09-Dec-22
Alembic Pharmaceuticals receives USFDA approval for Desonide Cream
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%. The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05%, of Padagis US LLC. Desonide Cream, 0.05% is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of corticosteroid-responsive dermatoses. Refer to our label for full indication.

Desonide Cream, 0.05%, has an estimated market size of US$12 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.

Previous News
  Alembic Pharma spurts on receiving USFDA nod for Ketorolac Tromethamine Injection
 ( Hot Pursuit - 03-Nov-22   13:12 )
  Alembic Pharmaceuticals AGM scheduled
 ( Corporate News - 06-Jun-23   18:21 )
  Volumes spurt at Alembic Pharmaceuticals Ltd counter
 ( Hot Pursuit - 20-Jul-23   14:30 )
  Alembic Pharmaceuticals to acquire 40% stake in Aleor Dermaceuticals
 ( Corporate News - 29-Mar-22   15:41 )
  Alembic Pharmaceuticals receives USFDA approval for Ketorolac Tromethamine Injection
 ( Corporate News - 03-Nov-22   10:49 )
  Alembic Pharma's oncology formulation facility undergoes USFDA audit
 ( Corporate News - 09-Mar-24   12:26 )
  Alembic Pharmaceuticals consolidated net profit declines 18.68% in the September 2022 quarter
 ( Results - Announcements 11-Nov-22   14:55 )
  Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide Ointment
 ( Corporate News - 08-Mar-22   15:01 )
  Alembic Pharmaceuticals receives EIR report from USFDA
 ( Corporate News - 11-Oct-21   15:05 )
  Alembic Pharmaceuticals receives USFDA approval for Desonide Cream
 ( Corporate News - 09-Dec-22   11:16 )
  Aleor Dermaceuticals receives USFDA approval for Metronidazole Gel
 ( Corporate News - 06-Sep-21   13:09 )
Other Stories
  GRP schedules AGM
  01-Jul-24   20:01
  Mahindra & Mahindra domestic PV sales jump 23% in June
  01-Jul-24   20:01
  Vipul Organics constructs new factory in Ambernath, Maharashtra
  01-Jul-24   20:00
  Greaves Engineering launches range of new CPCB IV+ Compliant Gensets
  01-Jul-24   19:41
  Godrej Properties to develop 7-acre land in Thanisandra, North Bengaluru
  01-Jul-24   19:39
  Rama Phosphates AGM scheduled
  01-Jul-24   19:34
  Take Solutions to convene AGM
  01-Jul-24   19:34
  Fischer Medical Ventures partners with Singapore-based Nervotec
  01-Jul-24   19:29
  NIIT appoints Pankaj Jathar as Chief Executive Officer
  01-Jul-24   19:27
  Dynacons Systems recognized as India's Leading Listed ESG Entities 2024
  01-Jul-24   19:26
Back Top