Alembic Pharmaceuticals Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

Alembic Pharmaceuticals announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, of Alcon Laboratories, Inc. (Alcon) NDA - 206276.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander.

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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, of Alcon Laboratories, Inc.

Olopatadine Hydrochloride Ophthalmic Solution USP is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander.

According to IQVIA, Olopatadine Hydrochloride Ophthalmic Solution USP has an estimated market size of $22 million for twelve months ending September 2024.

Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from USFDA.

Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients.

The pharmaceutical company’s consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024.

The scrip rose 0.06% to currently trade at Rs 1,101.05 on the BSE.

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The GMP inspection was conducted from 14 November 2024 to 22 November 2024. The USFDA issued Form-483 with 5 observations.

The company stated that it would provide a comprehensive response to the USFDA for the observations within the stipulated period. It also committed to maintaining the highest quality standards and compliance at all times.

Alembic Pharmaceuticals is in the business of development, manufacturing and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.

The pharmaceutical company’s consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024.

The scrip rallied 3.44% to currently trade at Rs 1,077.60 on the BSE.

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Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen).

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (192 final approvals and 26 tentative approvals) from USFDA.

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