Lab Ofichem manufactures active pharmaceutical ingredients (APIs) for both the veterinary and human market. These active compounds are distributed worldwide to pharmaceutical producers. The production of APIs is in accordance with the guidelines of Good Manufacturing Practices (GMP). In addition to production and developing APIs, Lab Ofichem also analyses APIs for external clients.
Lab Ofichem distinguishes itself in the following points:
- Modern high quality laboratory;
- Production following GMP guidelines
- ISO 9001-2010 certified;
- Years of experience;
of new APIs;
- Development and validation of analytical methods
an active Substance Master File (ASMF) using the eCTD format,
if possible a CEP will be requested;
- Advice and support
with registrations for clients;
- Collaboration with various external parties.
The laboratory of Lab Ofichem was completely renewed in May 2011. The spaces are furnished with modern equipment which meet all quality requirements.
Years of experience
Lab Ofichem was founded in the mid seventies. Thanks to our years of experience we have become an information-production and distribution centre with a large international network.
Advice and support
Our main priority is to give advice and support to clients in every possible way. We help customers in increasingly complex documentation and registration procedures for medicines. The compiling of an ASMF is a good example. In this the Regulatory Affairs department plays a major role.
The University of Groningen is one of the parties with which Lab Ofichem closely works. The university is not only used for the exchanging of information but also acts as a sounding board for Lab Ofichem and vice versa.
Lab Ofichem must comply with a lot of guidelines: GMP, ISO, GHS, Reach, Atex, (A)RI&E, etc. Because of these different directives Lab Ofichem is always keeping its facilities and organization up-to-date.
Lab Ofichem is environmentally aware and is conscious of the safety and welfare of its employees. For example the purchasing of a complete new waste water installation, various heat exchangers and geothermal sources which are integrated into the office, laboratory and production making them function as energy efficient as possible and a new extraction system for the factory making exposure to organic solvents and dust reduced to a minimum.
Would you like to know which APIs Lab Ofichem produces? Check out our product portfolio
. We can also develop
(link pagina Research & Development) or analyse APIs
for you. If you have questions or want more information, please contact us