Providing premier CMO, CDMO, and Third-Party commercial formulation & scale-up services for global markets through world-class facility infrastructure.
Cynco Labs operates a state-of-the-art manufacturing plant exclusively dedicated to non-sterile oral liquid formulations. De-risking international technology transfers, our complete footprint was systematically architecture-engineered from day one to comply fully with European cleanroom, containment, and manufacturing frameworks, positioning your product safely for seamless global expansion.
Custom formulation development, robust scale-up mechanics, analytical method validation, and full stability testing tracking ICH guidelines.
Commercial campaign manufacturing utilizing computerized recipe control systems, optimized tech transfers, and strict batch consistency.
Flexible contract manufacturing agreements with versatile batch scaling parameters to fulfill regional and high-capacity global supply networks.
Our facility actively holds formal regulatory approvals from CDSCO and is certified to **WHO GMP** standards. We maintain comprehensive documentation systems, rigorous CAPA tracking, full validation protocols, and an impeccable inspection lifecycle track record.
To assure long-term regulatory resilience for cross-border clients, our plant design replicates EudraLex Volume 4 (EU GMP) layout expectations. Unidirectional personnel and material flows eliminate cross-contamination pathways cleanly, providing a future-proof manufacturing landscape ready for EU market audit integration.
Engineered architecture highlights showing how our facility matches advanced cleanroom infrastructure standards:
| Facility Domain | Engineering Specifications Installed | Regulatory Alignment Framework |
|---|---|---|
| Cleanroom Classifications | Terminal HEPA filtration layout supporting Grade C and Grade D environmental states. | EU GMP Annex 1 / ISO 14644 balanced |
| Water System Systems | Highly-monitored Purified Water (PW) generation loop operating continuously. | European Pharmacopoeia (Ph. Eur.) benchmarked |
| Compounding & Mixing | Closed-loop automated mixing tanks ranging from 100L up to 500L with automated CIP/SIP. | Data Integrity & Contamination Control optimized |
| Packaging & Serialization | Amber PET/Glass automatic line integration with serialization mapping configurations. | EU Track-and-Trace infrastructure ready |
Our facilities are open for prospective client validation audits. Connect directly with our compliance and commercial engineering teams to submit your technical dossier or RFP.
Contact Business Development