Cipla's InvaGen Facility Gets Zero US FDA Form 483 Observations
Cipla’s InvaGen facility has received zero Form 483 observations from the US FDA following an inspection.
Current Good Manufacturing Practice (cGMP) | 27/10/2026 | By News Bureau
Strides Receives US FDA EIR for Flagship Facility in Bengaluru
Strides receives the US Food and Drug Administration (FDA) Establishment Inspection Report (EIR) for its flagship Bengaluru facility following a current Good Manufacturing Practice (cGMP) inspection conducted in May 2026.
Current Good Manufacturing Practice (cGMP) | 20/08/2026 | By News Bureau
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 | 620
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 | 795
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 | 487
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