Jubilant Pharmova | US FDA completes #inspection of company’s Active Pharmaceutical Ingredients (#API) #manufacturing facility at Nanjangud. The regulator has issued eight observations for the facility

NewsFlash | Aurobindo Pharma to transfer units constituting #API non-antibiotic division of the company to arm, Auro Pharma India via #slump sale

Jubilant Pharmova | US FDA classifies #API manufacturing facility at Voluntary Action Indicated (#VAI)

#Lupin | US FDA issues establishment inspection report for #API manufacturing unit in #Visakhapatnam

#JustIn | #USFDA issues complete #response letter for PDP-716 New Drug Application (#NDA) at #API manufacturing facility: SPARC

US FDA did not raise any #issues with the PDP-176 clinical #efficacy or #safety

No additional clinical #data or trials have been requested

Dr Reddy’s | US FDA completes pre-approval inspection (#PAI) & routine #GMP inspection at the company’s #API manufacturing facility in #Srikakulam, Andhra Pradesh

⭕️ The inspection closed with zero observations and classification of No Action Indicated (NAI)

⭕️ Alert: The facility was inspected from July 10-19, 2023