Last Updated on December 21, 2024 by The Health Master
USFDA inspection
In a significant boost to its operations in the United States, Alembic Pharmaceuticals Ltd. saw its shares rise by approximately 4% on Wednesday. The surge was triggered by the successful conclusion of a US Food and Drug Administration inspection (USFDA inspection) of the company’s cancer formulation facility in Panelav, Gujarat.
USFDA Inspection and Positive Outcome
The USFDA inspection has been conducted at the plant on October 7th and 8th.
The agency’s decision to conclude the inspection without issuing any Form 483 is a testament to the high standards maintained by Alembic’s manufacturing practices.
A Form 483 is a document issued by the USFDA to a company when an investigator discovers potential violations of the Food, Drug, and Cosmetic (FD&C) Act.
Recent USFDA Approval for Alcaftadine Ophthalmic Solution
In addition to the positive outcome of the inspection, Alembic Pharmaceuticals also received another piece of good news earlier this month.
On October 3rd, the company announced that it had secured final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Alcaftadine Ophthalmic Solution, 0.25% Over-The-Counter.
Therapeutic Equivalence to Lastacaft Solution
The approved ANDA is therapeutically equivalent to Lastacaft Solution, 0.25%, manufactured by AbbVie Inc.
Alcaftadine Ophthalmic Solution 0.25% is indicated for the short-term relief of irritated eyes caused by various allergens such as pollen, ragweed, grass, animal hair, and dander.
Strong US Presence and Future Outlook
With the latest USFDA approval and the successful inspection of its cancer formulation facility, Alembic Pharmaceuticals continues to strengthen its position in the US market.
As of October 3rd, the company had received a total of 216 ANDA approvals, including 189 final approvals and 27 preliminary clearances from the US drug authority.
This significant milestone underscores Alembic’s commitment to providing high-quality pharmaceutical products to patients worldwide.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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