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Alembic Pharmaceuticals Shares Surge 4% on Tentative USFDA Approval

The Diltiazem Hydrochloride Extended-Release capsules are used for managing hypertension.

Shares of Alembic Pharmaceuticals Ltd were trading 4% higher on 1 April after the company announced receiving tentative approval from USFDA.

In its regulatory filing, the company said that they had received tentative approval from the US Food and Drug Administration (USFDA) for generic Ribociclib pills that were used for the treatment of breast cancer during the March quarter.

The tablet is a generic equivalent to the Kisqali tablets of Novartis Pharmaceuticals Corporation and is used for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy.

Earlier in March, the US regulator conducted an inspection at the company’s oncology formulations unit at Panelav from 28 February to 8 March and concluded the inspection with 4 observations.

In its quarterly report for October-December quarter, the company reported a 48% year-on-year increase in its net profit to Rs 180.45 crore for the quarter under review from Rs 121.92 crore reported in the same quarter last year.

At 3:30 pm, the shares of Alembic Pharmaceuticals closed 2.12% higher at Rs 1,005.70 on NSE.

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