Alembic Pharmaceuticals Secures 8 USFDA Approvals for Key Drugs in Q3 FY24

Alembic Pharmaceuticals' stock witnessed a surge of over 5% on January 2 following the announcement of these FDA approvals. The company now boasts a total of 196 ANDA approvals, including 170 final and 26 tentative approvals from the USFDA.

Mumbai-based Alembic Pharmaceuticals Limited has received approvals for eight Abbreviated New Drug Applications (ANDA) from the US Food & Drug Administration (FDA) during the third quarter of the fiscal year 2024. 

Among these eight drugs, five received final nod while others have been approved tentatively. 

List of Drugs Who Received USFDA Approvals

In the final approvals, Alembic received the green light for Selexipag Tablets (200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg), Dapsone gel (7.5 per cent), Fluorouracil Injection USP 5g/100mL, Pharmacy Bulk Package (Vial), Carmustine for Injection USP 100 mg/vial (single-dose vial), and Acyclovir Cream (5%). 

The company also secured tentative approvals for Rivaroxaban Tablets USP, Dapsone gel, and Osimertinib Tablets.

Among these, Selexipag Tablets, used under the brand name Uptravi Tablets, aim to treat pulmonary arterial hypertension (PAH), delaying disease progression and reducing the risk of hospitalisation. Rivaroxaban Tablets, branded as Xarelto Tablets. Further, it focuses on reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Dapsone gel, known as Aczone Gel, is indicated for the topical treatment of acne vulgaris, while Bromfenac Ophthalmic Solution, named Prolensa Ophthalmic Solution, targets the treatment of postoperative inflammation and reduction of ocular pain in patients after cataract surgery.

Fluorouracil Injection, with the brand name Adrucil Injection, is indicated for the treatment of adenocarcinoma in various organs, including the colon, rectum, breast, stomach, and pancreas. Carmustine for Injection, branded as BiCNU Injection, serves as palliative therapy for brain tumours and is used in multiple myeloma.

Lastly, Acyclovir Cream, under the brand name Zovirax Cream, treats recurrent herpes labialis in adults and adolescents.

Established in 1907, Alembic Pharmaceuticals is a prominent pharmaceutical company in India, recognised for its vertical integration in developing, manufacturing, and marketing pharmaceutical products and substances. The company claims to hold a leading position in the macrolides segment of anti-infective drugs in India.

Alembic Pharmaceuticals' stock witnessed a surge of over 5% on January 2 following the announcement of these FDA approvals. The company now boasts a total of 196 ANDA approvals, including 170 final and 26 tentative approvals from the USFDA.

In the last six months, Alembic Pharma's stock has exhibited strong performance, rallying nearly 29%, outperforming the Nifty 50 benchmark, which rose approximately 12% during the same period.