Aspen API response to COVID-19 Latest update / 17 March 2022
Aspen Oss’ response to COVID-19
As countries and companies around the world develop plans to manage the COVID-19 outbreak in their communities, Aspen wants to assure our customers we have implemented plans to keep our employees safe, taken actions to insure continuity of our manufacturing operations and developed strategies to insure the on-ongoing supply of products to our customers around...
March 24, 2020Successful GMP inspection by the Dutch Health Authorities
Aspen Oss B.V. is proud to announce the extension of our GMP Compliance for our API production sites in The Netherlands.
January 29, 2020Upgrading and expansion of HCG API manufacturing completed
Aspen Oss has completed a major upgrading and expansion project at its hCG manufacturing facility in Boxtel, the Netherlands; an extensive project that was started in 2017. Through its collection program “Mothers for Mothers”, urine from pregnant Dutch women is collected on a weekly basis. From the urine we extract the API human Chorionic Gonadotrophin...
September 5, 2019Successful ANVISA inspection on Heparin Sodium
In the week of May 13-17, 2019 the Brazilian authorities – ANVISA – inspected the Aspen Oss facilities with a special focus on Heparin Sodium. The inspection was closed and concluded with the highest possible score: “satisfactory”. Aspen Oss is very proud of this result, being a result of great teamwork of our highly motivated...
June 3, 2019Aspen Oss now ISO14011 and OHSAS 18001 certified
Aspen Oss is proud to announce that we are now an ISO 14001 and OHSAS 18001 certified company. After an intense audit week earlier this year, the external audit team concluded their inspection by expressing that Aspen Oss has demonstrated to have a high adherence to safety and environmental standards. Aspen Oss B.V. believes that,...
September 6, 2018EDQM had granted a CEP for Leuprorelin
European Directorate for the Quality of Medicines (EDQM) has granted a quality certificate for Leuprorelin It is our pleasure to inform you that the European Directorate for the Quality of Medicines (EDQM) has granted a CEP for Leuprorelin to Aspen Oss on September 26th, 2017. Leuprorelin is the 20th CEP obtained by Aspen Oss and is...
October 3, 2017Successful GMP inspection for Aspen Oss
Aspen Oss B.V. is proud to announce the extension of our GMP Compliance for the production locations Diosite and Moleneind in Oss – The Netherlands. During the 5 days inspection held from September 26th to September 30th, 2016 the Dutch Health Care Inspectorate (DHI) had a close look on the operations related to our biochemical,...
November 24, 2016FDA successfully inspects Aspen Oss
Aspen Oss is pleased to confirm that the US Food and Drug Administration (FDA) has completed a successful inspection of the API manufacturing facilities in Oss, the Netherlands during the period of September 22nd until September 25th, 2014. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and...
October 2, 2014EDQM granted CEP for tibolone
On March 7th, the EDQM published on its website the issuance of a CEP/Certificate of Suitability for our active substance Tibolone. Having this CEP in hands, we are able to support your registrations in the countries of the European Community in a quick and easy way.
March 13, 2014New GMP certificate Diosite and Moleneind
Resulting from a successful inspection by the Dutch Health Care Inspectorate of our production sites Diosite (Veersemeer/De Geer), Moleneind (Kloosterstraat) and Boxtel (Boseind) from November 19th to November 22nd 2013, we have received a new Certificate of GMP Compliance as manufacturer of active pharmaceutical substances, on our new legal entity Aspen Oss B.V. This new GMP...
January 8, 2014Successful GMP inspection diosite Moleneind
Aspen Oss B.V. is proud to announce the extention of our cGMP Compliance for the production locations Diosite and Moleneind in Oss – The Netherlands. During the 4 days inspection from November 19th to November 22nd, the Dutch Health Care Inspectorate had a close look on the operations related to our biochemical and chemical active ingredients...
November 26, 2013
