Crassula Facilities | WHO-GMP PQNS Manufacturing
Blsiter Machine

WHO-GMP manufacturing with PQNS capsule & softgel lines

Crassula’s manufacturing site is a 20,000 m² facility dedicated to prescription tablets and PQNS-enabled capsules and softgels. In-house QC/QA laboratories, stability chambers and ISO 9001/13485 quality systems support quality, reliability and global supply readiness, from formulation to finished pack.

01Manufacturing facility

One site, R&D to commercial

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

Focus

  1. 01Prescription tablets and capsules: film-coated, controlled-release and fixed-dose combinations.
  2. 02PQNS capsule and softgel manufacturing with validated cleaning and electronic batch records.
  3. 03Environmental monitoring, controlled flows and ICH-guided qualification.
High-speed blister packaging machine producing serialized prescription packs
Fig. 01 High-speed blister packaging producing serialized prescription packs
Site area
20,000 m²Dedicated to prescription tablets and PQNS-enabled capsules and softgels
In-house
QC/QAQuality control and assurance laboratories
Stability
ICH chambersStability programs to ICH guidance
02Capabilities

Formulation to finished pack

End-to-end support built on robust quality systems, across six connected capabilities.

  1. Product Development

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

  2. PQNS Capsules & Softgels

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

  3. Manufacturing

    Granulation, compression, coating and blistering/bottling, with in-process controls at critical steps.

  4. Analytical & Stability

    Assay and content uniformity, dissolution and micro; ICH stability chambers; LC–MS/MS-ready methods.

  5. Regulatory & Dossiers

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

  6. Packaging & Serialization

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

03Quality & certifications

Quality by system

Validated cleaning, electronic batch records, environmental monitoring and ICH-guided qualification support every batch.

  • FDA Registered
  • GMP
  • HACCP
  • ISO 22000
  • Kosher
  • Halal
GMP seal

Facilities operate under WHO-GMP manufacturing practices.

Certifications: FDA Registered, GMP, HACCP, ISO 22000, Kosher, Halal
04Finished packs

Blister & bottle formats

Artwork control, GS1 serialization and track-and-trace, across a range of blister configurations and cavity layouts.

Range of blister configurations and cavity layouts for finished packs
Fig. 02 Blister configurations and cavity layouts for finished packs
05Technical visit

Plan a technical visit

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

Contact manufacturing About Crassula