THC

White label

Valcon Medical is a European contract manufacturing organization, specialized in the manufacturing of medical cannabis extracts. We offer a complete outsourcing solution covering every phase from formulation and development to the delivery of a finished product.

As your supplier, we will support you in the product approval process. This includes compilation of all regulatory documentation required for a smooth introduction of your white label products to the market.

Our promise is to deliver the highest quality of products while assuring consistent and scalable supply.

Product content

Full-spectrum CO2 – extracted
30 mL standardized oil solution
THC: 25 mg/mL; CBD: ≤ 0.1% w/w
MCT carrier oil
EU GACP/GMP cannabis floss input, origin Denmark

Products are manufactured under EU-GMP and tested in accordance with the German Monograph for cannabis extracts, DAB Eingestellter Cannabisextract, and the European Pharmacopoeia, Ph. Eur. The product is composed of a soft extract from Cannabis Sativa L. ‘White Widow’ flower (floss) standardized with MCT (medium-chain triglycerides) oil to 25 mg/mL THC and <1 mg/mL CBD. Input: EU GACP/GMP cannabis floss, origin Denmark. The extraction solvent is carbon dioxide.

Select preferred potency

We offer THC cannabis oil in one formulation of 25 mg/mL according to the table below. Special formulations can be ordered under manufacturing service request.

Starting material

The starting material – Cannabis Sativa L – used for extraction and manufacturing is cultivated in accordance with Good Agricultural and Collection Practice (GACP) for Starting Materials on Herbal Origin and required provisions of the EU GMP guideline. Starting material is cultivated in Denmark by Schroll Medical to meet the requirements of the European Pharmacopoeia and the Danish Cannabis Flower Monograph.

Compliance

White label products are manufactured under EU-GMP and tested in accordance with the German Monograph for cannabis extracts, DAB Eingestellter Cannabisextract, and the European Pharmacopoeia, Ph. Eur. We only apply well established accredited laboratories performing the required range of analysis, including chemical, physical, and microbiological analysis of starting materials, intermediates and finished products. All according to validated analytical methods.

White label products are subject to stability according to ICH guidelines Q1A, Q1B, and EU-GMP guidelines.

Valcon Medical is certified by the Danish Medicines Agency for manufacturing and export of cannabis bulk, intermediate, and primary products.

Brochure

Download Brochure

Packaging

Valcon Medical offers a selection of primary-and secondary packaging solutions. Whether you require a lid with- or without child resistance, or encapsulation for a dosing syringe, we can manufacture accordingly. The product can be delivered labeled or unlabeled and packaged in outer carton with dosing syringe and leaflet.

Tamper evident
Child resistant cap (optional)
Encapsulation for dosing syringe (optional)
Dosing syringe (optional)
Brown amber glass flask
Label

Product specifications

Product name
To be determined by customer
Product description
Standardized full-spectrum cannabis oil
Product form
Oral fluid
Product composition
THC: 25 mg/mL; CBD < 1 mg/mL (THC 2,5% w/w; CBD 0,1% w/w)
Input material
Cannabis Sativa L. (White Widow), Schroll Medical, Denmark
Storage conditions
2-8 °C or 15-25 °C
Primary packaging
Amber glass bottle 30 mL, type III; Screw cap PP/HD-PE/LD-PE
Product ID
060518
Product monograph
DAB Eingestellter Cannabisextract, and the European Pharmacopoeia, Ph. Eur.
Application
For oral use
Carrier
MCT, CAS: 73398-61-5
Extraction
Carbon dioxide
Shelf life
Stability according to ICH guidelines Q1A, Q1B, and EU-GMP
Dosing
To be determined by customer
Secondary packaging
1. Label with product information, expiry and batch number placed on the primary packaging.
2. Outer carton with printed product information, expiry, and batch number.
3. Dosing pipette placed in outer carton.
4. Preparation method information sheet placed in outer carton.

GDP

Valcon Medical’s supply chain complies with Good Distribution Practice (GDP). Qualified shipping solutions to customers include temperature monitoring according to individual product specifications.