Apitoria Pharma receives 5 observations from USFDA for API facility
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
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
The new facility will enhance AbbVie’s chemical synthesis capacity to support domestic production of current and next-generation neuroscience, immunology, and oncology medicines
NewCo’s pipeline includes five investigational medicines
The Genexus platform enables Next-Generation Sequencing with significantly faster turnaround times
Deepak has around 25 years of work experience with reputed companies viz. UPL Group, Teva Group, AkzoNobel India, Ranbaxy Laboratories, and Dr. Reddy’s Laboratories
The inspection was conducted from July 22-25, 2025
The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs
The company received one observation in the Form-483
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