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Alembic Pharmaceuticals receives final USFDA nod for Difluprednate 0.05%

News by Aliceblue News Desk

28 Jan 2026

Alembic Pharmaceuticals receives final USFDA nod for Difluprednate 0.05%

Introduction

Leading pharmaceutical manufacturer received USFDA final approval for Difluprednate Ophthalmic Emulsion 0.05%, indicated for ocular surgery inflammation, pain management, and endogenous anterior uveitis treatment.

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Share price movement of Alembic Pharmaceuticals

On January 27, 2026, Alembic Pharmaceuticals Ltd opened at ₹762.35, down 0.03% from its previous close of ₹762.55. The stock touched a high of ₹763.10 (0.07%) and a low of ₹745.00. By 3:40 PM, it traded at ₹756.75, a 0.76% decline, with a market cap of ₹14,874.91 crore.

Alembic Pharma Gets USFDA Approval

Alembic Pharmaceuticals Limited received final approval from the USFDA for Difluprednate Ophthalmic Emulsion, 0.05%, following acceptance of its Abbreviated New Drug Application.

The approved product is therapeutically equivalent to Durezol Ophthalmic Emulsion, 0.05%, of Sandoz Inc. It is indicated for inflammation and pain after ocular surgery.

The drug is also indicated for treatment of endogenous anterior uveitis. With this approval, Alembic Pharmaceuticals Limited now has a cumulative total of 233 ANDA approvals from USFDA.

Stock performance of Alembic Pharmaceuticals for Period of 1 week, 6 months, and 1 year

Alembic Pharmaceuticals Ltd declined 0.08% over the past week, fell 21.8% in the past 6 months, and dropped 18.5% over the past 1 year.

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Shareholding pattern of Alembic Pharmaceuticals

ParticularsDec 2025Sep 2025Jun 2025
Promoter69.70%69.70%69.70%
FII4.20%4.00%4%
DII16.20%16.30%16.50%
Public9.80%9.90%10%

About Alembic Pharmaceuticals

Alembic Pharmaceuticals Limited (NSE: APLLTD) is an India-based pharmaceutical company focused on research, manufacturing, and global marketing of generic medicines with USFDA-approved facilities.

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Disclaimer: The above article is written for educational purposes, and the companies’ data mentioned in the article may change with respect to time. The securities quoted are exemplary and are not recommendatory.

FAQs

Q: Why is Alembic Pharmaceuticals Limited share price in focus today?

A: Alembic Pharmaceuticals Limited received USFDA final approval for Difluprednate Ophthalmic Emulsion 0.05%, equivalent to Durezol, for ocular inflammation treatment.

Q: What is Alembic Pharmaceuticals Limited’s main business focus?

A: Alembic Pharmaceuticals Limited focuses on research, manufacturing, and global marketing of generic pharmaceutical products with USFDA-approved facilities.

Q: What is the 52-week high and low of Alembic Pharmaceuticals Limited stock?

A: Alembic Pharmaceuticals Limited stock has a 52-week high of ₹1,107.80 and a 52-week low of ₹725.60.

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