Aurobindo Pharma share price up nearly 2% on USFDA approval for an injection

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Aurobindo’s Cyclophosphamide Injection will be available in ready-to-use (RTU) injection preparation.

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Aurobindo Pharma share price added nearly 2 percent in the early trade on August 27 after the company’s subsidiary received USFDA approval for Cyclophosphamide Injection.

The company’s subsidiary Eugia Pharma Specialities has received a 505(b)(2) NDA approval from the US Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials, as per the press release.

Aurobindo’s product will be available in ready-to-use (RTU) injection preparation.

The product shall be launched in the US market in the near term and will be manufactured in Eugia’s manufacturing facility in India.

The approved product has an addressable market size of USD 170 million for the twelve months ending June 2021 according to IQVIA.

This is the 19th product to be approved (including 3 tentative approvals) for Eugia.

Aurobindo now has a total of 482 ANDA approvals (453 Final approvals and 29 tentative approvals) from USFDA.

At 09:18 hrs Aurobindo Pharma was quoting at Rs 704.40, up Rs 6.30, or 0.90 percent on the BSE.

The share touched a 52-week high of Rs 1,063.75 and a 52-week low of Rs 660.10 on 11 May, 2021 and 24 August, 2021, respectively.

Currently, it is trading 33.78 percent below its 52-week high and 6.71 percent above its 52-week low.