Alembic Pharmaceuticals Secures USFDA Nod for Diltiazem Tablets

Alembic Pharmaceuticals today received its final USFDA clearance of its ANDA of Diltiazem Hydrochloride Tablets 30mg, 60mg, 90mg, and 120mg.

This is a strategic victory that strengthens the position of the U.S. generics market of Alembic. The therapeutic equivalence of the approved drug is to Cardizem Tablets, a reference-listed product of Bausch Health of the same strengths.

Under this consent, Diltiazem Hydrochloride Tablets by Alembic can be introduced in the very competitive American market.

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The patented drug is commonly used in the treatment of chronic stable angina and angina caused by coronary artery spasms- a condition that continues to have a constant demand in cardiovascular care. The takeover widens the portfolio of Alembic, which forms its long-term growth strategy. Alembic reported that with the current clearance the only ANDA approvals it had are 230 (210 final approvals and 20 tentative).

The expansion of the pipeline shows that the company focuses on complex generics and strives to expand its operations in regulated markets. The approval is seen by industry observers as an extension of the philosophy at Alembic of establishing a strong base in major therapeutic fields.

The company is also strengthening its cardiovascular portfolio and its image as a reliable manufacturer of generics as it gears up to launch its new product in the U.S. As a company with another USFDA green light, Alembic is also confident in its direction and momentum; it can continue to gain momentum in the market where quality, timing, and regulatory trust remains the most significant factors.