Manufacturer of GMP-compliant cannabinoid active ingredients (THC, CBD) and manufacturing kits for magistral formulation production in pharmacies and clinics
alpha-cannabis Pharma GmbH
Sandstraße 5A, 31749 AuetalNew on Amplifa
About alpha-cannabis Pharma
alpha-cannabis Pharma GmbH is a German pharmaceutical company based in Auetal, Lower Saxony. Since its founding in 2016, the company has focused exclusively on the medical potential of the naturally occurring constituents of the cannabis plant (cannabinoids) and is thus one of the pioneers of the industry. The company develops, produces and supplies cannabis-based active ingredients (APIs) for therapeutic use as well as GMP-compliant, monograph-conform substances (DAC/DAB, Ph. Eur.) based on THC (dronabinol) and CBD. The portfolio includes Dronabinol Solution 25 mg/ml according to NRF 22.8., active ingredient substances in various pack sizes, manufacturing kits including an identification kit for Delta 9 THC as well as further cannabinoids (CBG, CBC, CBN) with purities from 99 % and a certificate of analysis (CoA). Customers are hospitals, clinics, pharmacies and the pharmaceutical industry; bulk deliveries as white label are additionally offered to the pharmaceutical, cosmetic and food industries. The company is registered with EUDRA as a manufacturer of GMP-compliant medicinal products and is subject to supervision by the BfArM.
- Site
- Auetal
- Processes
- Manufacture of APIs / pharmaceutical active ingredients (cannabinoids THC/CBD), Analytics / quality control (in-house analytics, identification of Delta 9 THC, CoA), Manufacture of pharmaceutical preparations (Dronabinol solution 25 mg/ml NRF 22.8., manufacturing, Consulting for physicians and pharmacists, Manufacture of magistral-formulation active ingredients (NRF 22.8.), Manufacturing kits incl. identification kit, Analytics, White label / private label bulk deliveries
- Materials
- Dronabinol (THC), Cannabidiol (CBD), Cannabigerol (CBG), Cannabichromene (CBC), Cannabinol (CBN)
- Certificates
- GMP, GMP-compliant manufacturing (EUDRA-registered), License under § 4 MedCanG, ISO 9001
- Founded
- 2016
- Industries
- Pharmaceutical industry, Pharmacies, Clinics/hospitals, Cosmetics industry, Food industry
- 01
Development and formulation creation
- 02
Manufacture of cannabinoid active ingredients (APIs)
- 03
In-house analytics and quality control with CoA
- 04
Filling / manufacturing kits
- 05
Distribution to pharmacies, clinics and pharmaceutical wholesalers
- 06
White-label bulk deliveries
Active Ingredients and Substances
Dronabinol (THC)
Active ingredient as a solution 25 mg/ml (NRF 22.8.) and as a substance in packs of 500 mg to 5000 mg.
Cannabidiol (CBD)
Active ingredient substance with over 99 % CBD, available as a 100-g pack.
Cannabigerol (CBG)
Non-GMP substance with 99 % purity in 1-g and 10-g packs.
Cannabichromene (CBC)
Non-GMP substance with 99 % purity in 1-g and 10-g packs.
Cannabinol (CBN)
Non-GMP substance with 99 % purity in 1-g and 10-g packs.
Location
Auetal
DEHeadquarters with production and analytics
- Materials
- THC, CBD, CBG, CBC, CBN
- In-house analytics
- Process engineering production facilities
Products and Substances
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of APIs / pharmaceutical active ingredients (cannabinoids THC/CBD)Engineering | – | – | – | – | Cannabinoids (THC, CBD, CBG, CBC, CBN) |
| Analytics / quality control (in-house analytics, identification of Delta 9 THC, CoA)Testing | – | – | – | – | Cannabinoids |
| Manufacture of pharmaceutical preparations (Dronabinol solution 25 mg/ml NRF 22.8., manufacturingAssembly | – | – | – | – | Dronabinol (THC), Oily solution |
Additional services
Reference customers
Quality and Regulatory Approval
As a manufacturer of GMP-compliant medicinal products, the company is registered with EUDRA and is subject to supervision by the BfArM (Federal Opium Office) as well as, in matters of drug safety, by the Hannover Trade Supervisory Office. In-house analytics and process engineering equipment enable the supply of the full spectrum of cannabis-based active ingredients; the substances are delivered in accordance with monographs (DAC/DAB, Ph. Eur.) or with an in-house specification and certificate of analysis (CoA).
| Evidence | Auetal |
|---|---|
| GMP-compliant manufacturing (EUDRA-registered) | |
| License under § 4 MedCanG | |
| ISO 9001 |
History
- 2016
Foundation of alpha-cannabis Pharma GmbH with an exclusive focus on the medical potential of cannabinoids