Alembic Pharmaceuticals has strengthened its US generics portfolio with two significant regulatory approvals from the US Food and Drug Administration (USFDA). The company received final approval for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg on April 17, 2025, followed by approval for Amlodipine and Atorvastatin tablets in multiple strengths.
The approved Carbamazepine product is therapeutically equivalent to Novartis Pharmaceuticals Corporation's Tegretol Tablets 200 mg. This anticonvulsant medication is primarily indicated for seizure disorders and also for treating neuropathic pain conditions, particularly trigeminal neuralgia, a chronic facial nerve pain disorder. According to IQVIA data, the estimated US market size for Carbamazepine Tablets USP, 200 mg was approximately $32 million for the 12-month period ending December 2024.
In a separate development, Alembic secured USFDA approval for its generic version of Amlodipine and Atorvastatin tablets in eleven different strength combinations. These include 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg formulations. The approved product is therapeutically equivalent to Pharmacia and Upjohn Co LLC's Caduet tablets and is indicated for the treatment of hypertension.
Expanding Therapeutic Portfolio
These approvals represent significant additions to Alembic's growing presence in the US generics market, particularly in the central nervous system (CNS) and cardiovascular therapeutic segments. The Carbamazepine approval enhances the company's CNS portfolio, while the Amlodipine-Atorvastatin combination strengthens its cardiovascular offerings.
"These approvals align with our strategy to diversify our product portfolio across key therapeutic areas," said a company representative. "Both products address significant medical needs and represent important market opportunities for Alembic in the US."
Growing ANDA Approval Count
With these recent regulatory achievements, Alembic Pharmaceuticals now holds a total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals. This growing approval count reflects the company's consistent regulatory success and commitment to expanding its generic drug offerings in the US market.
The approvals come at a time when generic manufacturers are facing increasing competition and pricing pressures in the US market. However, Alembic's focus on diversifying its portfolio across multiple therapeutic areas positions the company to navigate these challenges effectively.
Market Impact and Future Outlook
The US generic pharmaceutical market continues to be a key growth driver for Indian pharmaceutical companies like Alembic. The addition of these products to Alembic's commercial portfolio is expected to contribute positively to the company's revenue from US operations.
Industry analysts note that while the Carbamazepine market is relatively stable, the Amlodipine-Atorvastatin combination represents a larger market opportunity due to the prevalence of hypertension and cardiovascular conditions in the US population.
Alembic Pharmaceuticals continues to invest in research and development to expand its pipeline of generic products for the US market, with a particular focus on complex generics and specialty products that offer higher margins and face less competition.
