Aurobindo Pharma under USFDA scrutiny

Hyderabad headquartered pharmaceutical company Aurobindo Pharma is under the US Food and Drug Administration (USFDA) scrutiny once again. While the US regulator is conducting inspections at Aurobindo pharma’s Unit – IV at Pashamylaram in Medak district of Telangana, the inspections at its units V and VIII happened last week, people aware of the matter said. Spread over 33 acres, Aurobindo’s Unit-IV is a dedicated manufacturing facility for generic sterile injectables, opthalmics, and low volume parenterals.The facilities under the FDA lens manufacturers now are Aurobindo’s unit V at Patancheru at Hyderabad. The unit manufacturers-antibiotics (sterile and non sterile) and unit VIII manufactures Anti Retrovirals (ARVs), CVS, CNS (non sterile). “3-4 auditors from the US FDA are conducting inspections at three units of Aurobindo. Unit V and VIII were inspected last week, while the inspections are still going on in unit IV,”added sources. It is learnt that unit 5 and 8 received four observations each but the nature of those observations could not be confirmed. Aurobindo did not comment on questions from ET.Sources said unit 4 is a medium sized plant while five and eight are smaller units.Aurobindo has seen intense scrutiny on the manufacturer process of valsartan, an anti-hypertension drug, that was found to contain carcinogenic impurities. Apart from Aurobindo, those impurities were detected in several other batches manufactured by drug makers. The inspections are critical as earlier in October this year the USFDA had red flagged data records at Aurobindo’s Unit 7. It found that its several documents were incomplete, inaccurate or potentially misleading. The FDA conducted a Current Good Manufacturing Practices (CGMP) inspection, which ended in seven observations. The observations were made after an inspection during 19-27 September, resulting in its shares tumbling to all time low in several years. Nevertheless, earlier in June this year too, the USFDA had also conducted an inspection at company's Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad, from May 13 to May 24, 2019. The company has received a 'Form 483' with 10 observations.

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