Alembic Pharma Gets USFDA Nod for Generic Carbamazepine Tablets

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg, marking another significant addition to its growing generics portfolio.

Therapeutic Equivalent to Tegretol

The approved tablets are therapeutically equivalent to Tegretol Tablets, 200 mg, manufactured by Novartis Pharmaceuticals Corporation.

Carbamazepine is primarily prescribed as an anticonvulsant and is also used to manage pain associated with true trigeminal neuralgia, a chronic pain condition affecting the trigeminal nerve in the face.

U.S. Market Size and Potential

According to IQVIA data for the twelve months ending December 2024, the estimated market size for Carbamazepine Tablets, 200 mg, in the U.S. was approximately $32 million. With this approval, Alembic Pharmaceuticals is poised to tap into this niche market segment, further expanding its footprint in the U.S. generics space.

Strengthening Global Generics Portfolio

The latest approval brings Alembic’s total ANDA approvals from the USFDA to 222, which includes 196 final approvals and 26 tentative approvals. This milestone reinforces the company’s R&D-focused approach and its capabilities in bringing high-quality, affordable medicines to global markets.

Stock Performance

On April 03, 2025, Alembic Pharmaceuticals share price traded 0.09% lower at ₹850.90 at 11:57 AM (IST). Alembic Pharmaceuticals’ share price reached a 52-week high of ₹1,296.15 and a 52-week low of ₹725.60. As per BSE, the total traded volume for the stock stood at 3335 shares with a turnover of ₹28.47 lakhs.

According to exchange data, Alembic Pharmaceuticals shares are trading at a price-to-earnings (P/E) ratio of 26.57x, based on its trailing 12-month earnings per share (EPS) of ₹32.03, and a price-to-book (P/B) ratio of 3.32.

About the Company

Founded in 1907, Alembic Pharmaceuticals has evolved into a vertically integrated pharmaceutical company with a strong global presence.

Its manufacturing and R&D facilities are approved by several leading global regulatory authorities, including the USFDA, underlining its commitment to international quality standards.

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