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Gland Pharma Shares Rally 7% on Securing USFDA Approval

After the inspection, the USFDA issued a Form 483 with two observations.

Shares of Gland Pharma Ltd were trading in the green and 7% higher on 8 April after the company announced receiving USFDA approval for Eribulin Mesylate injection that is used to treat breast cancer that spreads across various parts of the body.

In its regulatory filing, the company said, “Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial (Product).”

The filing added that this will be the first generic approval on the market, and they will launch it in the near term through its marketing partners.

According to IQVIA, these injection sales in the US are approximately $92 million for twelve months.

The company is developing several complex injectables, which include Eribulin Mesylate injection with Orbicular Pharmaceutical Technologies Private Limited.

In its quarterly report for October-December, the company reported a 17% year-on-year decline in its consolidated net profit to Rs 192 crore for the quarter from Rs 231.9 crore reported in the same quarter last year.

On the contrary, the company’s revenue saw a significant growth to Rs 1,545.2 crore, marking a 65% YoY increase from Rs 938.3 crore for the same quarter of the previous fiscal year.

At 3:23 pm, the shares of Gland Pharma were trading 6.57% higher at Rs 1,869.90 on NSE.

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