Aspen API. Our Quality & Regulatory
At Aspen API, we work from a deeply rooted and proactive quality culture. Our high quality products are manufactured in compliance with cGMP, ICH and SHE regulations and standards. Teamwork by highly motivated, experienced and skilled experts is one of our key success factors. We all contribute as quality is at the heart of what we do.
Extremely high standards
Our compliance standards are extremely high. It is in our DNA to offer high quality APIs used for finished dosage forms that contribute to improving patients’ lives worldwide, meanwhile protecting our employees, the environment and our products. Our Quality Control Laboratories comply with ICH guidelines – particularly cGMP’s & ALCOA principles – and are capable of performing all testing in support of the product range.
Our Quality Control Laboratories form an integral part of our cGMP manufacturing network. Stringent controls are applied for chemical starting materials, in-process controls and the extensive characterization of final products. We ensure quality APIs are manufactured in compliance with the relevant regulations and regulatory dossier such as US FDA DMF, CEP, J-DMF and Brazilian DMF.
Our facilities are successfully inspected and approved by our customers and regulatory authorities such as the US FDA, EDQM, Dutch Health Authorities and PMDA. Authorities and customers compliment us for excellence in implementing data integrity in the organization.
Tomorrow we’ll be better than today is not just a quote. It is a way of being, living, working. We embrace Lean Six Sigma and we continuously strive to improve. Together with our Yellow, Green and Black Belts we make projects and processes smarter, more efficient, and more sustainable.
Our Regulatory Excellence
We have comprehensive regulatory experience in countries all over the world. We know, are involved, and act proactively on changes in monographs and on governmental regulations and expectations. Customers rely on our high quality dossiers and customer oriented support and we provide assurance that their API project is in experienced hands.
Aspen API is an active and valued member of APIC and as such directly involved in discussions within EMA, US FDA, EDQM and ICH. Due to our participation in USP and EP expert groups, we play a key role in several expert panels.
In our knowledge base we placed various documents related to our product list and that are at your direct disposal.
Should you wish to have an account, just contact us. Once your registration is approved, you will have access to the below mentioned documents of all Aspen Oss APIs on our current Product List:
- Typical Certificate of Analysis (if applicable, separate documents for EP and USP specifications are available)
- Safety Data Sheet (EU and US version)
- Residual Solvents statement
- Origin statement
- GMP Information on API’s manufactured at Aspen Oss B.V.