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Aurobindo Pharma Falls 6% in One Week After Receiving EIR from USFDA

Aurobindo Pharma shares fell 1% to Rs 497.85 in intra-day trade on Tuesday.

Shares of Aurobindo Pharma fell 1% to Rs 497.85 in intra-day trade on Tuesday for the fifth consecutive day after the company’s half-subsidiary Aurolife received an Inspection Inspection Report (EIR) for its US plant in Raleigh, North Carolina, from the United States Food and Drug Administration (USFDA).


Shares of the pharmaceutical company have fallen 6% in the past week since the announcement, while the S&P BSE Sensex index has lost 4%. It was trading at a 52-week low. Meanwhile, Aurobindo has underperformed the market over the past six months, down 31%, while the S&P BSE Sensex edged down just 0.07%.


On September 22, Aurobindo Pharma said: “The Raleigh, North Carolina facility owned by the company’s wholly-owned subsidiary Aurolife Pharma LLC has received an EIR that mentions inspection a Voluntary Action Initiated (VAI) by the USFDA. Currently, the FDA pre-approval inspection and GMP inspections are over”.


Aurobindo Pharma has three plants in the US that are being installed and commissioned – Dayton, Puerto Rico and Raleigh. In addition, the company has a Vizag injectables plant, biosimilars and vaccine plants in India, followed by a plant in various stages of construction in China.


Aurobindo operates primarily in the US, Europe and growth markets. Existing growth markets include South Africa, Brazil, Canada and Africa. The company has a strong presence in the antiretroviral space, selling antiretroviral drugs to more than 125 countries through participation in global tenders initiated by international organizations such as the Global Fund, USAID/PEPFAR and the country-specific Ministry of Health (MoH).


The company has 24 manufacturing plants worldwide (21 in India, one in Brazil, Puerto Rico and Portugal) and 9 R&D facilities. The US is the company’s largest market, accounting for about 47.4% of FY22 revenue. Meanwhile, Europe is the second largest market after the US, accounting for about 27.6% of FY22 revenue.

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