Active Pharmaceutical Ingredients
Customer Synthesis & Contract Manufacturing of Active Pharmaceutical Ingredients (API)
LIPOMED has a broad expertise as manufacturer of API with a particular focus on potent substances and niche products. Our facilities allow the synthesis of smallest development batches and a scale up to batches up to kilogram quantities. API manufacturing is in compliance with GMP standards for clinical research and marketing batches.
Upon request, LIPOMED offers support to customers for achieving worldwide regulatory approvals of finished products containing LIPOMED’s API and for compiling the pharmaceutical dossiers accordingly (such as CEP, DMF, ASMF, IMPD/IND, IMA/MAA), and covering all the aspects of dossier life-cycle management.