Alembic Pharma Share Price Rises Over 3% on USFDA Nod for Dapagliflozin Tablets

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic Dapagliflozin Tablets (5 mg and 10 mg).

The approval is for the company’s Abbreviated New Drug Application (ANDA).

Equivalent to AstraZeneca’s Farxiga

The approved medicine is the generic version of AstraZeneca AB’s reference drug Farxiga.

Dapagliflozin is used:

• To reduce the risk of heart failure hospitalisation in adults with type 2 diabetes
• To improve blood sugar control along with diet and exercise

180-Day Generic Exclusivity

Alembic was among the first companies to file the ANDA with a Paragraph IV certification.
Because of this, the company will get 180 days of shared generic exclusivity in the US market.

The drug has an estimated market size of $10.49 billion for the 12 months ending December 2025.

Strong USFDA Approval Track Record

With this approval, Alembic now has:

• 235 total ANDA approvals
  • 217 final approvals
  • 18 tentative approvals

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Alembic Pharma Share Price Movement

Alembic Pharmaceuticals share price was trading at ₹680.65 on April 7, up 3.77% for the day. The stock opened at ₹655.55 and moved between a low of ₹652.15 and a high of ₹683 during the session. The company has a market capitalisation of ₹13.38K crore and a P/E ratio of 21.23. Over the past year, the stock has touched a 52-week high of ₹1,107.90 and a low of ₹635.80, and it currently offers a dividend yield of 1.62% with a quarterly dividend of ₹2.76.

About Alembic Pharma

Alembic Pharmaceuticals is a vertically integrated pharmaceutical company founded in 1907.
It manufactures and markets generic medicines globally and is a leader in branded generics in India.

Conclusion

The USFDA approval and 180-day exclusivity strengthen Alembic Pharma’s presence in the US generics market and open a major revenue opportunity in a multi-billion-dollar segment.

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