The Quality Lowdown: Pandemic Inspection Results Trickle In As Investigators Venture Out
US FDA inspections lead to warning letters for Aurobindo and Health Plus, while Emergent BioSolutions site escapes nearly unscathed; Sun waits for Halol revisit and Jubilant suffers poor-quality costs as agency investigators resume domestic surveillance post-omicron.
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After years of pandemic-related delays, US FDA reinspects key Sun plant in Halol, India, hit with “official action indicated” inspection findings that tabled approvals just before COVID-19 impeded travel. However, new findings are generating further discussions.
What value do PE funds see in Aurobindo Pharma’s injectables business as the company looks for a partner? Why is Aurobindo looking for acquisitions in India as it sets a domestic revenue target of $133m in three years from the formulations business? Scrip takes a look.
Indian firm Jubilant Pharmova demonstrated a host of deficiencies at its manufacturing facility in Roorkee, including for cleanliness, laboratory controls, control procedures and data management, according to a US FDA Form 483 that has just been unveiled.