Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated April 17, 2025, titled "Alembic Pharmaceuticals receives USFDA Final Approval for Carbamazepine Tablets USP, 200 mg".
APLLTD · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Alembic Pharmaceuticals has received final approval from the US FDA for its generic version of Carbamazepine Tablets USP, 200 mg, an anticonvulsant drug. The product is therapeutically equivalent to Novartis's Tegretol Tablets, 200 mg, and is also used to treat pain from trigeminal neuralgia. The addressable US market for this drug is estimated at US$32 million for the 12 months ending December 2024, according to IQVIA. This approval takes Alembic's cumulative ANDA tally to 222 (196 final approvals and 26 tentative approvals) from the USFDA. The company can now launch the product in the US market, adding to its growing generic portfolio in one of the world's largest pharmaceutical markets.
Mildly positive for shareholders — the approval opens up a US$32 million market opportunity, though generic competition will likely limit Alembic's share. It reinforces the company's strong USFDA track record with 222 cumulative ANDA approvals, supporting its long-term US revenue growth.