Shares of Alembic Pharmaceuticals Ltd. rose nearly 4%, reaching a day’s high of Rs 1,303.90 on 9th October, after the company announced that the United States Food and Drug Administration (USFDA) completed its inspection of the oncology formulation facility in Panelav, Gujarat, without any complaints. The USFDA inspected the facility on the 7th and 8th of October.

Form 483 is a document issued by the Food and Drug Administration (FDA) to a company’s management if an investigator identifies conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act.

On 3rd October, the firm announced receiving the USFDA’s final approval for its Abbreviated New Drug Application (ANDA) for Alcaftadine Ophthalmic Solution, 0.25% Over-The-Counter (OTC).

The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Lastacaft Solution, 0.25%, manufactured by AbbVie Inc.

Alcaftadine Ophthalmic Solution 0.25% temporarily relieves itchy eyes caused by pollen, ragweed, grass, animal hair, and dander.

As of 3rd October, Alembic Pharma had received 216 ANDA approvals, including 189 final approvals and 27 tentative approvals from the US drug regulator.

The stock has surged by 64.5% so far in 2024. The company’s market capitalisation stands at Rs 24,766 crore.

At 12:05 PM, the shares of Alembic Pharma were trading 0.93% higher at Rs 1,258.40 on NSE.

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