WHO-GMP Manufacturing with PQNS Capsule & Softgel Lines

A 20,000 m² site dedicated to prescription tablets and PQNS-enabled capsules and softgels. In-house QC/QA labs, stability chambers, and ISO 9001/13485 systems ensure quality, reliability, and global supply readiness.

Manufacturing Facility

A modern site for solid oral dosage forms and PQNS-enabled capsules/softgels, integrating R&D, scale-up, and commercial production under rigorous quality systems.

Certifications: FDA Registered, GMP, HACCP, ISO 22000, Kosher, Halal — FDA Registered · GMP · HACCP · ISO 22000 · Kosher · Halal

Focus

Prescription tablets & capsules (film-coated, controlled-release, fixed-dose combos)
PQNS capsule/softgel manufacturing with validated cleaning and electronic batch records
Environmental monitoring, controlled flows, and ICH-guided qualification

Capabilities

End-to-end support from formulation to finished pack, built on robust quality systems.

Product Development

Pre-formulation, excipient screening, QbD, scale-up, and tech transfer.

PQNS Capsules & Softgels

Programmable release layers, gut-friendly profiles, and dose-efficient designs.

Manufacturing

Granulation, compression, coating, blistering/bottling with IPC at critical steps.

Analytical & Stability

Assay & CU, dissolution, micro; ICH stability chambers; LC–MS/MS-ready methods.

Regulatory & Dossiers

CTD compilation, validation protocols/reports, variations and change control.

Packaging & Serialization

Blister and bottle formats, artwork control, GS1 serialization and track-and-trace.

Range of blister configurations and cavity layouts for finished packs

Plan a Technical Visit

Review PQNS capsule/softgel options, dossier readiness, stability plans, and packaging with our team.

Contact Manufacturing About Crassula