Alembic Pharma Gets USFDA Final Approval for Parkinson’s Disease Drug Tablets

Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Carbidopa, Levodopa and Entacapone tablets under the Abbreviated New Drug Application (ANDA) pathway.

The approved medicine is therapeutically equivalent to Stalevo tablets of Orion Corporation and will be used for the treatment of Parkinson’s disease.

Strengths and Usage

The approval covers multiple dosage strengths, allowing doctors flexibility in treatment based on patient needs.
These combination tablets help manage symptoms of Parkinson’s disease, a neurological disorder that affects movement.

Strong USFDA Approval Track Record

With this latest approval, Alembic now has a total of 234 ANDA approvals from the USFDA, including 214 final approvals and 20 tentative approvals, highlighting the company’s strong presence in the US generics market.

About Alembic Pharmaceuticals

Founded in 1907, Alembic Pharmaceuticals is a research-driven and vertically integrated global pharmaceutical company headquartered in India.
The company manufactures and markets generic and branded medicines worldwide, supported by advanced research and manufacturing facilities approved by major global regulators, including the USFDA.

Also Read: REC Dividend Record Date on February 06: Interim Dividend of ₹4.60!

Alembic Pharmaceuticals Share Price Movement

Alembic Pharmaceuticals share price (NSE: APLLTD) was trading at ₹793.75, down ₹16.70 or 2.06% on February 6 at around 1:15 PM IST. The stock opened at ₹805.60, touched an intraday high of ₹808, and fell to a low of ₹776.20 during the session. Over the past year, the stock recorded a 52-week high of ₹1,107.90 and a 52-week low of ₹725.20. Alembic Pharmaceuticals currently offers a dividend yield of 1.39%, with a quarterly dividend payout of ₹2.76 per share.

Conclusion

The USFDA’s final approval for Parkinson’s disease treatment tablets strengthens Alembic Pharmaceuticals’ generics portfolio and reinforces its growing footprint in the US market, supporting future global growth.

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