Cannabinoid API · Artavaz, Armenia
Seed to crystal.EU-GMP by design.
One site at Artavaz, Armenia, taking CBD, CBG and CBN from cultivation to isolate API under a quality system designed for EU-GMP certification, for pharmaceutical manufacturers and distributors in the EU.
Value chain
One site. Cultivation to API.
The whole chain runs under one quality system, on one site. Material moves one way, through airlocks, from the growing rooms to the released API store.
Cultivation
GACP controlled-environment cultivation in closed flowering rooms on three-tier vertical racking. LED lighting and CO2 enrichment are scheduled through the building management system.
Harvest and drying
Dedicated drying and packing rooms, quarantine hold and one-way material flow keep each harvest lot separate and documented.
Supercritical CO2 extraction
Solvent-free primary extraction in an ISO 7 extraction laboratory with closed-loop CO2 recovery. ATEX zoning, gas detection and emergency shutdown cover the downstream solvent-handling areas of purification.
Purification and crystallisation
Distillation, chromatographic purification and crystallisation bring the extract to isolate: the crystal the name refers to.
Isolate API release
The in-house QC laboratory tests every batch and issues its Certificate of Analysis under EU-GMP Part II and ICH Q7.
Finished dose
In Phase 2, a capsule line under EU-GMP Part I fills oral dosage forms from the site's own API.
Products
Three isolates. One finished form.
Cannabinoid active pharmaceutical ingredients for EU pharmaceutical distributors, API traders and finished-dose formulators. Supply follows EU-GMP certification; every lot ships with its Certificate of Analysis.
CBD isolate API
C21H30O2 · cannabidiol
Lead product. Crystallised cannabidiol isolate, with the sales specification set against the European Pharmacopoeia monograph for cannabidiol. Purity is a design target until the first qualified batch.
CBG isolate API
C21H32O2 · cannabigerol
Minor cannabinoid produced on the same validated extraction and purification train, for formulators who need a documented single-source supply.
CBN isolate API
C21H26O2 · cannabinol
Minor cannabinoid on the same train, released under the same quality system and the same Certificate of Analysis discipline.
Oral capsules
Finished dose · Phase 2
Hard-shell capsules filled from the site's own isolate under EU-GMP Part I. A committed second phase.
Facility
Artavaz, Kotayk
A two-floor factory on a greenfield plot in the Tsaghkadzor community, Kotayk province, Armenia. Closed rooms, no outdoor growing. Reverse-osmosis water with a dedicated irrigation loop, zoned HVAC with pressure cascades, and a building management system that records the environment of every cycle.
- 2 floorsFactory building
- 11Flowering rooms
- 3-tierVertical cultivation
- ISO 7Extraction laboratory
Traceability
Every batch, provable
A digital seed-to-sale platform records each batch's genealogy from genetics through cultivation cycle, harvest lot, extraction batch and API lot to finished dose. An evidentiary layer on validated ERP, LIMS and BMS systems, built to Annex 11 and GAMP 5. In development alongside the facility.
- QR identification of every container; full batch history in minutes.
- Hash-proofed Certificates of Analysis and a timeline of deviations and release decisions.
- Automated reporting for the Armenian authority and for EU importers.
- Verifiable provenance documents for distributors, in support of the EU import chain.
Standards
Designed to the rulebook
EU-GMP Part II / ICH Q7
The API line is designed to EU-GMP Part II and ICH Q7; the capsule line to Part I. Unidirectional flow, classified areas, validated systems and the DQ-IQ-OQ-PQ ladder are in the drawings before the first batch. Cleaning validation follows Annex 15 on a health-based exposure limit basis; computerised systems follow Annex 11 and GAMP 5.
GACP cultivation
Cultivation follows the EMA guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin, in a fully closed, controlled environment.
Classified areas and flow
ISO 7 and ISO 8 areas, airlocks, two-stage gowning, a positive-pressure clean corridor and a separate service corridor, so clean and waste flows never cross.
ATEX and site security
Explosion-protection zoning, gas detection, interlocked explosion-proof doors, emergency shutdown and CO2 suppression in the solvent-handling areas of purification. CCTV, audited access control and intrusion detection across production, storage and entry points.
Roadmap
Phased, qualified, then certified
Foundation
Site and design basis
Project company established as successor to VANASHIN LLC. Site secured at Artavaz. GMP basis of design and validation plan prepared with an international GMP engineering advisor. Licence pathway under way.
Phase 1
Build and qualify
Two-floor shell, the first flowering rooms, the supercritical CO2 extraction and API train, the QC laboratory, validated ERP, LIMS and BMS. Armenian manufacturing licence and national GMP certificate pursued in parallel with construction.
Certification
EU-GMP inspection
DQ, IQ, OQ, then PQ: three cultivation cycles and three extraction batches. Mock audit, Site Master File, inspection by an EU competent authority. Written Confirmation route for API export pursued in parallel.
Phase 2
Full capacity and finished dose
The remaining flowering rooms and the capsule line under EU-GMP Part I. Supply to EU distributors, API traders and formulators; importers in the Gulf states as a later wave.
Team
People of record
Suren Ohanov
Founder and CEO
Carries the project from licence application to EU-GMP inspection.
Artem Azatyan
Master Grower
GACP cultivation, genetics and the three performance-qualification cultivation cycles.
Vahan Hovhannisyan
Project Owner
Programme ownership across design, build, qualification and systems.
Emma Vardanyan
Legal and regulatory
Licensing, the national GMP pathway and the EU import route.
Contact
API supply, partnership, regulatory
KRYSENTIS is a B2B supplier. Write to us about API supply qualification, finished-dose partnerships, or regulatory and audit enquiries. Supply is subject to EU-GMP certification; we answer with documents.