Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission
Lyfius Pharma restarts operations at Penicillin-G manufacturing facility
During the quarter, US formulations revenue increased by 13.5 per cent YoY to Rs. 4,072 crore
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
The observations are of procedural in nature and will be responded to within the stipulated time
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