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Alembic Pharma Gains 10% After USFDA Approval for Antipsychotic Drug

The plan includes reducing R&D spending from 14-15% to 7-8% and scaling up new facilities.

Shares of Alembic Pharmaceuticals Ltd. rose by almost 10% to touch a 52-week high of Rs 1,192.75 on 24 July after the company announced securing approval from the USFDA for its antipsychotic drug.

The company has received final USFDA approval for fluphenazine hydrochloride tablets in multiple dosages. This approval was for the Abbreviated New Drug Application (ANDA) for 1 mg, 2.5 mg, 5 mg, and 10 mg tablets.

The approved ANDA is therapeutically equivalent to Prolixin tablets, which are manufactured by Apothecon Inc. Prolixin tablets are available in similar dosages.

Fluphenazine hydrochloride tablets are used to manage psychotic disorders and are prescribed to treat mental disorders such as schizophrenia.

The USFDA granted 210 ANDA approvals to the firm, out of which 182 were final and 28 were tentative.

On 9 July, the organisation also accepted a definitive approval for Bromfenac Ophthalmic Solution, 0.07%. It has a market volume of $168 million by March 2024, as per IQVIA projections.

The company’s consolidated net profit rose by 16.78% to Rs 178.21 crore in Q4 FY24. Revenue from operations increased by 7.85% to Rs 1,516.98 crore in Q4 FY24.

The stock has surged by 19.88% in the last six months and by 23.63% in the last three months.

At 3:30 PM, the shares of Alembic Pharma closed 8.17% higher at Rs 1,174.35 on BSE.

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