Activities Ace Pharmaceuticals
Ace delivers custom pharmaceutical solutions for specific patient needs to ensure an expedient supply of medicines. We do this by registering our medicines. While a medicine is not yet licensed we make it available through named patient programmes. In the Netherlands we also supply compounded products.
The Ace-group consists of a range of companies that all aim to supply custom pharmaceutical solutions.
Our modern GMP-production facility is located in Zeewolde, the Netherlands. Here we produce our solid and semi-solid dosage forms. In 2019 we have started with our aseptic/sterile production.
Besides production, development, packaging, analysis, registration and sales of our products is also performed from our facility in Zeewolde.
Ace Pharmaceuticals BV
Since the start in 1990, Ace Pharmaceuticals has focused on the registration of medical need products. In the beginning these were often veterinairy medicines (Ace Veterinary Products BV), as of 2001 the focus has switched to human medicines.
Most of our products are licensed in Europe and are supplied all over the world. The product pages provide more information.
Supply of our unlicensed medicines is done in accordance with local guidelines for named patient programmes. In the Netherlands, these are supplied in accordance with article 3.17 of the Regeling Geneesmiddelenwet (Medicines Act).
For clinical trials, Ace Pharmaceuticals can provide both production or packaging and distribution of medicines.
Ace Apotheek
Ace Apotheek is an independent unit of Ace Pharmaceuticals. Ace Apotheek has been included in the pharmacy register of the Dutch Health and Youth Care Inspectorate (IGJ) as of 2011. All compounded products are made by Ace Apotheek for pharmacies in the Netherlands.
Ace Compounding BV
In 2019 Ace Compounding has been introduced. Within the Netherlands, Ace Compounding delivers a full range of compounded products as well as creams and ointments. Herewith we assist pharmacies by providing a suitable treatment for their patients when licensed alternatives are not available.
We have the capability to supply all possible dosage forms, ranging from oral forms to aseptic or sterile products. Most is supplied from stock in accordance with the guidelines (Circulaire) from the Dutch Health and Youth Care Inspectorate (IGJ).
We also offer pharmacies ad hoc preparations as a service if a single named patient needs a specific product.
Ace Pharmaceuticals Belgium BV
Ace Pharmaceuticals Belgium BV was established in 2019. Our Key Account Managers in Belgium have years of experience in the field and serve as a first point of contact for physicians and (hospital) pharmacists.
In 2021 a MA for Broxil®, pheneticillin, as capsules and powder for oral suspension was received in Belgium.
Ace Pharmaceuticals GmbH
Ace Pharmaceuticals GmbH was established in 2021 for the introduction of our products in Germany. In Germany, the MA for Acecort®, hydrocortisone, tablets was received in 2021.
Orphan Drug Designation
Ace Pharmaceuticals has received an Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for three products.
Levamisole HCl for the treatment of nephrotic syndrome (Elmisol®): EU/3/05/324
Artesunate for the treatment of malaria (Malacef®): EU/3/07/430
Allopurinol sodium for the treatment of perinatal asphyxia (Allokid®): EU/3/15/1493
Licenses
Our licenses make it possible to carry out all our activities. We are proud to have the following licenses and certificates.
Manufacturing Authorisation 109098F Wholesale Distributor Authorisation 5139 G GMP Certificate A GMP Certificate B GDP Certificate Schepenveld 41 GDP Certificate Schepenveld 21-12