“The Company has received the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAl) status from the US Food & Drug Administration (USFDA) for Unit IV,” Aurobindo Pharma
said in an exchange filing today.
The USFDA had inspected Company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad, from 4th to 13th November 2019. At the end of the inspection, the company had issued a 'Form 483' with 14 observations.
On November 13, 2019, Aurobindo Pharma
had informed the stock exchanges that it believed that none of these observations are related to data integrity issues.
Currently, Unit 4 has 15 abbreviated new drug applications (ANDA) approvals pending over next one year.
“Aurobindo Pharma remains focused on US generics, on the back of a strong ANDA pipeline with good mix of complex generics. The company is also in the process of integrating Apotex and hopes to derive further synergies from it for its Europe business,” analysts at Motilal Oswal Securities said in Q3FY20 result update.
“Based on integration of the Sandoz business and increasing market share for already commercialized products, we expect 15 per cent CAGR in earnings over FY19-22E. We value Aurobindo Pharma at 9x12-month forward earnings to arrive at price target of Rs 645,” it added.