Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated July 26, 2025, titled "Alembic Pharmaceuticals receives USFDA Final Approval for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Carbamazepine Extended-Release Tablets USP in 100 mg, 200 mg, and 400 mg strengths. The approved product is therapeutically equivalent to Novartis's Tegretol-XR and is indicated as an anticonvulsant and for the treatment of trigeminal neuralgia pain. The addressable US market for these strengths is estimated at US$ 71 million for the twelve months ending March 2025, according to IQVIA. With this approval, Alembic's cumulative ANDA count from the USFDA rises to 225, comprising 202 final approvals and 23 tentative approvals. The approval strengthens Alembic's presence in the US generics market and adds a new revenue opportunity to its portfolio.
Positive near-term news for shareholders as it expands Alembic's US product offering into a US$ 71 million addressable market and reinforces its strong USFDA approval track record. Stock reaction may be modest since individual approvals typically contribute small incremental revenue, but it supports steady, long-term growth in the US business.