Corporate News     29-Jul-22
Alembic Pharmaceuticals receives USFDA approval for Diclofenac Sodium Topical Gel, 3%
Used for topical treatment of actinic keratoses
Alembic Pharmaceuticals today announced that its wholly owned subsidiary, Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, 3%, of fougera Pharmaceuticals Inc. (Fougera).

Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy. Diclofenac Sodium Topical Gel, 3% has an estimated market size of. US$10 million for twelve months ending Mar., 2022 according to IQVIA.

Previous News
  Alembic Pharmaceuticals consolidated net profit rises 2.41% in the September 2023 quarter
 ( Results - Announcements 07-Nov-23   15:08 )
  Alembic Pharmaceuticals to discuss results
 ( Corporate News - 17-Oct-23   10:13 )
  Alembic Pharmaceuticals fixes record date for interim dividend
 ( Market Beat - Reports 27-Jul-22   14:22 )
  Alembic Pharma gains on USFDA nod for Fluorouracil injection
 ( Hot Pursuit - 06-Mar-23   11:13 )
  Alembic Pharmaceuticals Ltd leads losers in 'A' group
 ( Hot Pursuit - 09-Aug-24   15:00 )
  Alembic receives final approval for Fluorouracil Injection
 ( Corporate News - 06-Mar-23   11:32 )
  Alembic receives USFDA approval for Fulvestrant Injection
 ( Corporate News - 26-Dec-22   09:10 )
  Alembic Pharmaceuticals to conduct AGM
 ( Corporate News - 20-Sep-22   16:05 )
  Alembic Pharmaceuticals consolidated net profit declines 49.22% in the September 2021 quarter
 ( Results - Announcements 10-Nov-21   15:38 )
  Alembic Pharmaceuticals gets USFDA approval
 ( Corporate News - 27-Oct-22   11:52 )
  Alembic Pharma announces US FDA nod for topical corticosteroid
 ( Hot Pursuit - 25-Apr-22   11:32 )
Other Stories
  Tata Motors records 12% decline in Q2 sales
  01-Oct-24   18:04
  Tata Motors records 15% decline in September sales
  01-Oct-24   17:55
  Man Infra set to launch its highly anticipated Vile Parle project
  01-Oct-24   17:48
  Padam Cotton Yarns to declare Quarterly Result
  01-Oct-24   17:39
  Blueblood Ventures schedules board meeting
  01-Oct-24   17:39
  CRISIL to discuss results
  01-Oct-24   17:39
  Indian Renewable Energy Deve. Agency to convene board meeting
  01-Oct-24   17:39
  Ashapuri Gold Ornament schedules board meeting
  01-Oct-24   17:38
  Bijoy Hans to conduct board meeting
  01-Oct-24   17:38
  RS Software (India) to announce Quarterly Result
  01-Oct-24   17:38
Back Top