A deeply rooted and pro-active quality culture
Aspen Oss works from a deeply rooted and pro-active quality culture. Our robust quality system ensures high product quality, which are manufactured in compliance with GMP, ICH and SHE regulations. Our key success factor is teamwork, supported by a highly motivated, knowledgeable and educated staff.
Our facilities are successfully inspected and approved by governmental authorities such as the US FDA, EMA, PMDA and others. Also, we are inspected almost weekly by our customers and therefore can proudly say that we are permanent inspection ready. We are complimented by authorities and customers for our degree of implementing data integrity in the organization.
Our Quality Control laboratories form an integral part of our cGMP manufacturing network. With the stringent controls for chemical starting materials, in-process controls and the extensive characterization of final products, we can ensure the right quality API, manufactured in compliance with the relevant regulations and its regulatory dossier (US-DMF, ASMF, CEP, J-DMF, etc.).
Complex and Highly Potent APIs
Almost 100 years strong in handling HPAPIs and complex chemical reactions
We are strong in the development, manufacturing and handling of complex reactions and highly potent compounds at various production scales with a specialization in steroid hormones.
Our HPAPIs are produced in OEB 4 and 5 classifications and we have a long history in working with OEL levels going as low as 0.01 µg/m3. Our heritage of working in the manufacturing of complex HPAPIs has enabled Aspen Oss to establish world class systems and procedures for the safe handling of these compounds.
If you want to learn more about HPAPI development and manufacturing capabilities, please click here
We understand your regulatory requirements.
Our team with a broad range of experience is available to support you at all stages from development through registration and commercialization. We facilitate your ongoing product support and new product launches globally and have broad regulatory experience, also in countries such as Japan, Brazil, Russia, India and China. We know, are involved, and act pro-actively on changes in monographs and on governmental regulations and expectations.
Furthermore, Aspen Oss is an active member of APIC and as such directly involved in discussions within EMA, FDA, EDQM and ICH. Furthermore, Aspen Oss is represented in expert groups of both USP and EP.
Customers appreciate our continuous high quality regulatory dossiers and high level of customer support.
If you want to learn more about our product portfolio and our regulatory dossiers, please visit our product search machine.
SHE – Safety, Health and Environment
We value the protection of our employees, the environment and our products.
Aspen Oss is committed to ensuring a proactive safety culture and considers SHE awareness and compliance as an imperative to our success. We manage SHE as an integral part of our business and we are an ISO 14001 and OHSAS 18001 certified company. We have a dedicated team of over 25 in-house SHE specialists with expert knowledge to ensure continuous improvement in SHE management and performance.
Aspen Oss B.V. is part of Aspen Pharmacare. We are a global supplier of high-quality active pharmaceutical ingredients (APIs). We want to conduct our business activities sustainably and therefore regard management of safety, health and the environment (SHE) as an integral part of our business operations. Our primary objectives are to create a safe and healthy working environment for our employees, contractors and partners, to minimize our impact on our environment – in terms of both environmental impact and safety – and to handle raw materials and energy efficiently. Our motto is ‘I work safely, or I don’t work at all’.