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Alembic Pharma's Gujarat plant clears USFDA inspection

9 Oct 2024 , 03:09 PM

Alembic Pharmaceuticals Ltd shares rose about 4% on Wednesday after the United States Food and Drug Administration (USFDA) concluded its inspection of the cancer formulation facility in Panelav, Gujarat, with no complaints. The USFDA assessed the plant on October 7 and 8.

Form 483 is a document that the FDA sends to a company’s management when an investigator discovers situations that may violate the Food, Drug, and Cosmetic (FD&C) Act.

Earlier on October 3, the pharmaceutical business informed the exchanges that it had acquired final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25% Over-The-Counter.

The business stated that the authorised ANDA is therapeutically similar to the reference-listed drug product (RLD) Lastacaft Solution, 0.25%, made by AbbVie Inc. (AbbVie).

Alcaftadine Ophthalmic Solution 0.25% provides short relief for irritated eyes caused by pollen, ragweed, grass, animal hair, or dander. As of October 3, the pharmaceutical company had received 216 ANDA approvals, including 189 final approvals and 27 preliminary clearances from the US drug authority.

At around 3.00 PM, Alembic Pharma was trading 0.93% lower at ₹1,235.20 per piece, against the previous close of ₹1,246.85 on NSE. The counter touched an intraday high and low of ₹1,303.90, and ₹1,225.90, respectively.

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Related Tags

  • Alembic Pharma
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  • Alembic Pharma USFDA
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