Indian Pharma Company Scores Major USFDA Approval for Game-Changing Capsule, Plans 5+ New Product Launches!
With the USFDA's green light, the Indian pharmaceutical company is poised to expand its product portfolio and strengthen its global presence
Alembic Pharmaceuticals Limited recently announced receiving final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules. The approval includes doses of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, therapeutically equivalent to Cardizem CD by Bausch Health.
Therapeutic Use:
Diltiazem Hydrochloride is approved for treating hypertension and managing angina, providing a versatile option either as a standalone treatment or in combination with other antihypertensive medications. This approval strengthens Alembic's presence in the cardiovascular segment in the US.
Financial Performance Snapshot:
For the recent quarter, Alembic Pharmaceuticals reported revenue of Rs 1,648 crore, reflecting a growth of 3 per cent year-over-year (YoY) and 6 per cent quarter-over-quarter (QoQ). The company's EBITDA reached Rs 257 crore, an 18 per cent YoY increase and a 7 per cent QoQ rise, with an EBITDA margin of 15.6 per cent. Net profit stood at Rs 153 crore, growing by 12 per cent YoY and 14 per cent QoQ, resulting in a net profit margin of 9.3 per cent. The company allocated 8 per cent of its sales, approximately Rs 132 crore, towards Research and Development (R&D), underlining its commitment to innovation.
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Market Potential:
According to IQVIA, the US market for Diltiazem Hydrochloride Extended-Release Capsules is estimated at approximately USD 105.3 million as of June 2024. Alembic’s USFDA-approved entry positions the company to capture a share of this significant market.
About Alembic's ANDA Portfolio:
With this approval, Alembic now holds a cumulative total of 218 ANDA approvals from the USFDA, including 191 final and 27 tentative approvals. This achievement reflects Alembic’s strategic focus on expanding its generics portfolio in the United States.
Global Operations:
Alembic operates in several key international markets, with the US contributing 68 per cent to its international revenue. Alembic's world-class R&D and manufacturing facilities are recognized globally, ensuring high standards of healthcare products.