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News about "Current Good Manufacturing Practice (CGMP)"
US FDA Completes Pre-Approval Inspection at Lupin's Somerset Facility with One Observation
The US Food and Drug Administration (FDA) has completed a pre-approval inspection of Lupin’s manufacturing facility in Somerset, New Jersey, USA, with one observation.
Current Good Manufacturing Practice (CGMP) | 11/10/2025 | By Dineshwori | 254
US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated
The US Food and Drug Administration (FDA) has concluded its inspection of Lupin’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.
Current Good Manufacturing Practice (cGMP) | 04/10/2025 | By Dineshwori | 349
Bionova Scientific, a full-service biologics contract development and manufacturing organisation (CDMO) and subsidiary of Asahi Kasei, has inaugurated a 10,000-square-foot plasmid DNA (pDNA) development and production facility in The Woodlands, Texas.
Current Good Manufacturing Practice (CGMP) | 13/08/2025 | By Darshana | 184
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