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Alembic Pharmaceuticals Shares Rally 7% on Receiving USFDA Approvals

The US regulator had inspected its Gujarat plant from 28 February to 8 March.

Shares of Alembic Pharmaceuticals Ltd rallied 7% on 2 January after the company announced receiving various tentative and final approvals from the USFDA (US Food and Drug Administration) during the October-December quarter of the current fiscal year. 

List of Final Approval received by the company during the Q4FY24 from the USFDA; 

  • Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg. 
  • Dapsone gel, 7.5%.
  • Fluorouracil Injection USP, 5 g/100 mL (50 mg/mL), Pharmacy Bulk Package (Vial). 
  • Carmustine for Injection USP, 100 mg/vial (Single-dose Vial).
  • Acyclovir Cream, 5%, 

List of Tentative approval received by the company during the Q4FY24 from the USFDA;

  • Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg.
  • Bromfenac Ophthalmic Solution, 0.07%. 
  • Osimertinib Tablets, 40 mg and 80 mg. 

The company has received a total of 196 ANDA (abbreviated new drug application) from the USFDA, including 170 final approvals and 26 tentative approvals. 

The company plans to launch 20 products during the current fiscal year, focusing on oral solids, derma segments, and injectables. 

In its quarterly report for July-September, the company reported a 3.21% year-on-year increase in its net profit to Rs 136.56 crore for the quarter. 

At 3:30 pm, the shares of Alembic Pharmaceuticals closed 3.41% higher at Rs 792 on NSE. 

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