Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Acetaminophen Injection, 1,000 mg/ 100 mL single-dose vial (SDV). Aurobindo's Acetaminophen Injection is a generic equivalent of Mallinckrodt's Ofirmev® Injection. The product will be launched in December 2020.

Acetaminophen Injection is indicated for the treatment of mild to moderate pain in adult and pediatric patients 2 years and older. The injection is also set to treat moderate to severe pain with adjunctiveopioid analgesics in adult and pediatric patients 2 years and older, and reduction of fever in adult and pediatric patients. The approved product has an estimated market size of US$ 339 million for the twelvemonths ending August 2020 according to IQVIA.

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This warning letter follows the earlier letter dated 4 June 2020 issuing a Official Action Indicated (OAI) status for Dayton facility. The company assured that the existing business from this facility will not be impacted. The company also said it will be engaging with the regulator and is fully committed in resolving this issue at the earliest.

The pharma company's consolidated net profit jumped 22.8% to Rs 780.68 crore on 8.9% increase in net sales to Rs 5,835.23 crore in Q1 June 2020 over Q1 June 2019.

Aurobindo Pharma is engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs).

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Aurobindo Pharma announced that AuroLife Pharma LLC, a whollyowned stepdown subsidiary of the Company, has received a warning letter from USFDA for its oral solid manufacturing facility situated at Dayton, New Jersey.

This letter follows the earlier letter dated 04 June 2020 issuing a OAI status for this facility. The company believes that the existing business from this facility will not be impacted. The Company will be engaging with the regulator and are fully committed in resolving this issue at the earliest.

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Aurobindo Pharma has entered into a share purchase agreement today to acquire 100% equity share capital of MViyeS Pharma Ventures (MViyes).

MViyeS is holding 32.18% shareholding in Eugia Pharma Specialities Limited, a joint venture company in which the Company is holding 67.82%.

By this acquisition, both Eugia Pharma Specialities and MViyeS Pharma Ventures will become 100% subsidiaries of the Company.

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