Corporate News     06-Jan-22
Alembic Pharmaceuticals receives USFDA approval for Entacapone Tablets
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) for Entacapone Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of Orion Corporation.

Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease. , Entacapone Tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021 according to IQVIA.

Previous News
  Alembic Pharma Q1 PAT rises 12% YoY to Rs 135 cr
 ( Hot Pursuit - 08-Aug-24   15:48 )
  Alembic Pharma gets US FDA nod for anticoagulant Dabigatran
 ( Hot Pursuit - 13-Aug-24   13:46 )
  Alembic Pharma hits record high on USFDA nod for anti psychotic drug
 ( Hot Pursuit - 24-Jul-24   14:43 )
  Alembic Pharma gets USFDA nod for Betamethasone Valerate Foam
 ( Hot Pursuit - 24-Aug-24   16:59 )
  Alembic Pharma gets USFDA nod for stroke and blood clots drug
 ( Hot Pursuit - 18-Jun-24   14:27 )
  Alembic Pharma's Jarod facility gets five USFDA observations
 ( Hot Pursuit - 19-Dec-22   12:39 )
  Alembic Pharma receives USFDA approval for Dabigatran Etexilate Capsules
 ( Corporate News - 13-Aug-24   12:15 )
  Alembic Pharma records 48% growth in Q3 PAT
 ( Hot Pursuit - 05-Feb-24   16:29 )
  Alembic Pharm gets US FDA approvals for five products in Q1 FY24
 ( Hot Pursuit - 03-Jul-23   09:54 )
  Alembic Pharma's oncology formulation facility undergoes USFDA audit
 ( Corporate News - 09-Mar-24   12:26 )
  Alembic Pharmaceuticals receives multiple product approvals from USFDA
 ( Corporate News - 03-Jul-23   09:11 )
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