Archive · 28 Jul 2025
Alembic Pharmaceuticals Gets USFDA Nod for Carbamazepine
Alembic Pharmaceuticals got the green light from the US government to sell a cheaper version of a medicine called Carbamazepine.
This medicine comes in different strengths and helps people with seizures and nerve pain.
It's like they made a copy of an existing medicine, which is okay because it works the same way.
The original medicine is made by another company.
The market for this medicine is quite large, worth millions of dollars.
Alembic Pharmaceuticals received USFDA approval for generic Carbamazepine tablets.
The approval is for Carbamazepine extended-release tablets in 100 mg, 200 mg, and 400 mg strengths.
The ANDA is equivalent to Novartis Pharmaceuticals Corporation's Tegretol-XR.
Carbamazepine treats seizures and trigeminal neuralgia.
The market size for these tablets is estimated at $71 million.
- Who
- Alembic Pharmaceuticals and the USFDA.
- What
- Alembic Pharmaceuticals received USFDA approval for generic Carbamazepine tablets.
- When
- The approval was announced on Monday, July 28, 2025.
- Where
- In the United States.
- Why
- To provide an alternative treatment for seizures and nerve pain.
- Company
- Alembic Pharmaceuticals
- Drug Name
- Carbamazepine extended-release tablets
- USFDA Approval
- Yes
- Indications
- Seizures and trigeminal neuralgia
- Strengths
- 100 mg, 200 mg, and 400 mg
- Reference Drug
- Tegretol-XR
- Market Size
- $71 million