Shares of Aurobindo Pharma Ltd. dropped 1% from a day’s high of Rs 1,559.90 on 18th September after the company announced that its step-down subsidiary, Eugia Sterlite Pvt. Ltd., received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA).

The EIR relates to Aurobindo Pharma’s new injectable manufacturing facility in Parawada Mandal, Anakapalli district, Andhra Pradesh.

The USFDA conducted a pre-approval inspection of this facility from 28th March to 5th April, 2024. The company announced that the inspection is now closed and the EIR has been received.

Eugia Steriles, the entity involved, is a wholly-owned subsidiary of Eugia Pharma Specialities Limited, which is a step-down subsidiary of Aurobindo Pharma.

On 11th September, the company announced that Eugia Steriles’ new injectable facility received its first product approval from the USFDA. The regulator approved Lidocaine Hydrochloride Injection USP in 1% (10 mg/mL) and 2% (20 mg/mL) formulations.

This permission was granted based upon a supplement abbreviated new drug application (sANDA), which was filled as a prior approval supplement to add the new facility for manufacturing, labelling, packaging, and testing.

Eugia Pharma Specialities Ltd.’s Unit-III in Pashamylaram, Telangana, received an official action indicated (OAI) status from the USFDA in August 2024, indicating significant issues requiring regulatory action.

For June 2024, Aurobindo Pharma reported net sales of Rs 7,567.02 crore, up 10.46% from Rs 6,850.52 crore in June 2023. Net profit increased by 61.05% to Rs 919.22 crore, and EBITDA rose by 45.18% to Rs 1,840.50 crore.

At 3:30 PM, the shares of Aurobindo Pharma closed 1.06% lower at Rs 1,536 on NSE.

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