US FDA Approves Aurobindo to Manufacture Fondaparinux Sodium Injection

From the USFDA Aurobindo Pharma has received final approval to produce and market Fondaparinux Sodium injection used to prevent deep vein thrombosis.

The approval by US Food & Drug Administration (USFDA) is for multiple strengths of Fondaparinux Sodium injection of 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL, and 10 mg/0.8 mL single- dose prefilled syringes, the company said in a statement.

The approved ANDA is bioequivalent to the reference listed drug (RLD) product Arixtra Injection of Mylan Ireland and therapeutically proportional. The product will be launched in January 2018. To prevent deep vein thrombosis (DVT) Fondaparinux sodium injection is used.

As per Citing IMS data, the approved product the injection has an estimated market size of US$ 73 million for a year ending October 2017, the company said.

This is the 52nd ANDA (including 2 tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable and ophthalmic products, the company said.

From USFDA, at present Aurobindo has a total of 350 ANDA approvals (final approvals-313, including from Aurolife Pharma LLC-17, and tentative approvals-37).

Shares of Aurobindo Pharma Ltd were trading at Rs 690.7, up by Rs 6.75 or 0.99% from its previous closing of Rs 683.95 on the BSE. The scrip opened at Rs 683 and touched a high and low of Rs 701.4 and Rs 683 respectively.

Aurobindo manufactures injectable generic formulations (79% FY17 income) and active pharmaceutical ingredients (API – 21%). Out of the total formulation exports, the US business contributed 45% and Europe contributed 21% in FY17.

Its product portfolio is spread more than seven therapeutic / product areas, including antibiotics, antiretrovirals, cardiovascular, central nervous system, gastroenterological, anti-allergies, and anti-diabetics.


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