Alembic Pharma Secures USFDA Approval for 40 mg/mL Triamcinolone Acetonide Injection

Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its generic version of Triamcinolone Acetonide Injectable Suspension USP 40 mg/mL. The approval, granted under an abbreviated new drug application (ANDA), enables the company to supply this important corticosteroid formulation to the U.S. generics market.

This clearance represents another step forward in Alembic’s efforts to strengthen its product portfolio in regulated international markets, particularly in the United States.

About the Approved Formulation

The approved product, Triamcinolone Acetonide Injectable Suspension 40 mg/mL, is a corticosteroid medication designed to reduce inflammation within the body. It helps relieve symptoms such as redness, itching, and swelling that result from various allergic and skin conditions. 

The formulation is also commonly used for joint injections and intralesional administration to manage inflammation-related disorders. Alembic’s version has been approved as therapeutically equivalent to the reference listed drug, ensuring similar efficacy and safety for healthcare use.

Strengthening Presence in the U.S. Generics Market

This approval expands Alembic’s presence in the U.S. generics market, enabling it to meet demand for corticosteroid-based therapies. The company now holds a total of 227 ANDA approvals, which includes 206 final approvals and 21 tentative approvals from the USFDA. 

This growing portfolio reflects Alembic’s consistent regulatory progress and focus on developing complex injectable formulations for global markets. The clearance is expected to support the company’s U.S. generics business in the upcoming quarters as it prepares for commercial rollout.

Alembic Pharmaceuticals Share Price Update

As of 10:00 AM on October 20, 2025, Alembic Pharmaceuticals share price stood at ₹949, marking a 1.19% gain in early trade on the NSE. The company holds a market capitalisation of ₹18,647 crore. Over the past year, the stock has traded between a high of ₹1,188 and a low of ₹725, reflecting moderate movement within its range. 

With a price-to-earnings (P/E) ratio of 31.4 and a book value of ₹264, Alembic Pharmaceuticals continues to maintain a strong financial profile. The stock also offers a dividend yield of 1.15%, reinforcing its position as a stable player in the Indian pharmaceutical sector.

Read More:USFDA Speeds Up Approval for Generics Made in the US

Conclusion

As the company moves toward commercial distribution, this regulatory achievement marks another milestone in expanding its U.S. generics operations. With sustained focus on quality and compliance, Alembic continues to progress in developing advanced pharmaceutical solutions for regulated markets.

This approval positions the company to further consolidate its role as a key player in the injectable corticosteroid space and to strengthen its global market reach in the quarters ahead.

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