Dronabinol

Product Description

Dronabinol is a phyto-derived Δ9-tetrahydrocannabinol active pharmaceutical ingredient isolated from Cannabis sativa L. Following GMP release testing of the starting material, it is purified through validated process steps to obtain a highly concentrated resinous product with an assay of at least 95.0 % Δ9-THC, manufactured in compliance with USP and DAC at our EU-GMP site in Schlattingen, Switzerland.

Appearance: colourless to pale yellow, highly viscous resin (heated for transfer), no significant odour. Controlled substance – supply subject to import/export permits. Current release specifications and technical batches available; DMF/ASMF under development.

Pack sizes: 100 g, 1 kg and 2.5 kg in wide-neck bottles; 250 mg to 5 g packs planned for 2027. Storage at or below 25 °C, protected from light. Detailed specification, example CoA and safety data sheet on request.

Canexis Pharma AG

Country/Region:

Switzerland
Founded:

2020
On CPHI since:

2025
Certificates:

3
Employees:

1 - 24

Company types

CMO/CDMO

Generics/Biosimilars Manufacturer

Manufacturer/Innovator

Pharmaceutical company

Primary activities

API Producer

Custom Manufacturing/Custom Synthesis

Generic APIs producer

Intermediates Manufacturer

Natural Extracts

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Specifications

CAS Registry Number

1972-08-3
Details

Key specifications: Δ9-THC assay ≥ 95.0 %; exo-Δ9-THC ≤ 0.5 %; CBN ≤ 1.5 %; Δ8-THC ≤ 2.0 %; total impurities ≤ 5.0 %; water ≤ 0.5 %; sulfated ash ≤ 0.1 %; residual solvents n-pentane ≤ 5000 ppm; pesticides according to Ph. Eur. / EC 396/2005 / FAO-WHO; heavy metals As ≤ 0.2 ppm, Cd ≤ 0.3 ppm, Pb ≤ 0.5 ppm, Hg ≤ 0.1 ppm; mycotoxins total aflatoxins ≤ 4 µg/kg, ochratoxin A ≤ 20 µg/kg; microbiology TAMC ≤ 200 CFU/g, TYMC ≤ 20 CFU/g, specified pathogens absent.

Application areas: pharmaceutical development and formulation of controlled medicinal products. Product type: phyto-derived pure cannabinoid API, single-cannabinoid resinous matrix. Compliance: USP / DAC. CAS 1972-08-3.
Selling Points
International Approvals/Standards; Natural Ingredients; Place of Origin; Prompt Delivery; Quality Service; Small Orders Accepted; Manufactured in Switzerland under EU-GMP Part I and Part II licences, a Swissmedic manufacturing licence and a Swiss narcotics licence. Starting material from around ten qualified cultivation partners working to WHO-GACP, released under GMP against Ph. Eur.-based specifications. Release testing by qualified external GMP laboratories; Certificate of Analysis with every shipment. Technical/quality agreements, on-site audits, national regulatory documentation and DMF/ASMF support available. Shipping worldwide from Zurich Airport with temperature monitoring. Samples and technical batches on request.
Supplied from

Switzerland
Measured In
gram; kilogram