Boehringer Ingelheim has a long history in the field of biotechnology, having been in the industry for more than 35 years and in contract manufacturing since 1995. During that time, we have helped our customers bring more than 25 molecules to the market. This has earned us a reputation as one of the most experienced and reliable contract manufacturing organizations in the world.
Our high standing in the biotechnology industry is justified, as evidenced by our success in bringing 27 biopharmaceutical products to the market thus far. Three of these products are among the world's Top 20 on the list of best-selling biotech products. We are well aware of the responsibility that comes with contract manufacturing, i.e. of manufacturing consistently reliable biopharmaceutical products for patients.
Our biomanufacturing plants operate under cGMP and are approved as such. We not only meet the highest level of compliance, but strive to exceed it, both through regular internal audits and by asking external consultants to give us an outside perspective. We value our partners’ input and leverage these opportunities in order to continually improve our processes.
Our regulatory track record is thus another achievement which we are proud of. We have successfully undergone more than 130 regulatory cGMP audits and pre-approval inspections (PAI) by the EMA, FDA, Health Canada, PDMA (Japan), tFDA (Taiwan), KFDA (Korea), GCC-DR (Gulf States), COFEPRIS (Mexico), ANVISA (Brazil), ISP (Chile), MOH (Kazakhstan), MOH (Russia) and NDA (Uganda) for our multi-product facilities.
Many of our clients have undertaken annual inspections of our facilities without observing any critical issues. Continuous improvement programs and ongoing investments ensure that our facilities and equipment always meet the highest quality demands.
Thanks to Boehringer Ingelheim BioXcellence™ experience, expertise and manufacturing excellence, we can provide tailor-made solutions at every stage of your project.