/images/ppid_59c68470-image-178794252207177301.webp)
What is the story about?
Aurobindo Pharma said on Friday, August 28, that a US Food and Drug Administration (US FDA) inspection of an active pharmaceutical ingredient (API) manufacturing facility operated by its wholly owned subsidiary Apitoria Pharma concluded with three observations.
The inspection was conducted between August 24 and August 28 at Unit-VI of Apitoria Pharma in E-Bonangi Village, Parawada Mandal, Anakapalli district, Andhra Pradesh.
Aurobindo Pharma described all three observations as “procedural in nature” and said it would respond to the US FDA within the stipulated timeline.
The company didn't disclose further details about the observations.
An FDA observation at the end of an inspection identifies conditions that inspectors believe may violate regulatory requirements. It doesn't by itself amount to a final regulatory action, and companies are typically given an opportunity to respond with corrective measures.
Aurobindo Pharma said it remained committed to maintaining quality and compliance standards across its manufacturing facilities and would disclose further developments to the stock exchanges as required.
Second US FDA inspection in a week
The development comes just a week after another Aurobindo Pharma subsidiary underwent a US FDA inspection.
On August 21, the company said an inspection of AuroPeptides Ltd's manufacturing facility in Indrakaran Village, Kandi Mandal, Sangareddy district, Telangana, had concluded with one observation.
That inspection, conducted between August 17 and August 21, covered a facility that manufactures peptide APIs.
Aurobindo Pharma had said corrective action was initiated during the inspection itself and that the company would submit a formal response within the prescribed timeline.
Together, the two inspections have resulted in four observations across two Aurobindo Pharma subsidiaries in the space of a week. The company has characterised the latest three as procedural, while it hasn't disclosed details of the individual observations.
Aurobindo Pharma shares closed 0.92% higher at ₹1,652 on Friday, gaining ₹15 during the session.
Also Read: Aurobindo Pharma US FDA inspection ends with one observation at AuroPeptides facility
The inspection was conducted between August 24 and August 28 at Unit-VI of Apitoria Pharma in E-Bonangi Village, Parawada Mandal, Anakapalli district, Andhra Pradesh.
Aurobindo Pharma described all three observations as “procedural in nature” and said it would respond to the US FDA within the stipulated timeline.
The company didn't disclose further details about the observations.
An FDA observation at the end of an inspection identifies conditions that inspectors believe may violate regulatory requirements. It doesn't by itself amount to a final regulatory action, and companies are typically given an opportunity to respond with corrective measures.
Aurobindo Pharma said it remained committed to maintaining quality and compliance standards across its manufacturing facilities and would disclose further developments to the stock exchanges as required.
Second US FDA inspection in a week
The development comes just a week after another Aurobindo Pharma subsidiary underwent a US FDA inspection.
On August 21, the company said an inspection of AuroPeptides Ltd's manufacturing facility in Indrakaran Village, Kandi Mandal, Sangareddy district, Telangana, had concluded with one observation.
That inspection, conducted between August 17 and August 21, covered a facility that manufactures peptide APIs.
Aurobindo Pharma had said corrective action was initiated during the inspection itself and that the company would submit a formal response within the prescribed timeline.
Together, the two inspections have resulted in four observations across two Aurobindo Pharma subsidiaries in the space of a week. The company has characterised the latest three as procedural, while it hasn't disclosed details of the individual observations.
Aurobindo Pharma shares closed 0.92% higher at ₹1,652 on Friday, gaining ₹15 during the session.
Also Read: Aurobindo Pharma US FDA inspection ends with one observation at AuroPeptides facility
/images/ppid_59c68470-image-178799752498137986.webp)
