News about "Current Good Manufacturing Practice (CGMP)"

Cipla's InvaGen Facility Gets Zero US FDA Form 483 Observations

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 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

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

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 Opens Texas Facility to Strengthen Plasmid DNA Manufacturing for Cell and Gene Therapies

Bionova Scientific Opens Texas Facility to Strengthen Plasmid DNA Manufacturing for Cell and Gene Therapies

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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