HAPILA GmbH is a independent Contract developer and manufacturer (CDMO) that provides high-value services to pharma, biotech and fine chemicals client companies in the development and cGMP manufacture of active pharmaceutical ingredients (APIs). HAPILA supports the development and manufacture of drug products with patented processes and in-depth experience in the API value-creation chain from synthesis through purification to particle design, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use. All HAPILA APIs are manufactured in-house at its GMP certified facility at Gera, Germany.
In addition to API manufacturing, HAPILA GmbH provides independent development and scale up of chemical API synthesis including analytical method development, manufacturing of reference substances and development of purification processes based on its patented HAPIpur® technology that fully automates continuous counter current crystallization. We can also provide regulatory support with relevant documentation like ASMF, CEP and IMPD (Drug substance part). We can provide exclusive synthesis, process development and GMP manufacture in several labs and pilot plants up to 100 L scale for a wide range of high value drug substances such as steroids (e.g. Estriol), amino acids, etc.
HAPILA holds active ingredient-specific GMP certificates issued by relevant competent official authorities verified by regular inspections.
|Sales markets||Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America|
|Affiliated categories:||Custom Manufacturing (general category) |Filtration/ Separation/ Purification |Hormones & Synthetic Substances More|
Our Top products
Hapila GmbH provides wide range of pharmaceutical products which includes Corticoids. Contact us for more information.More info
Based on the comprehensive and reliable development performed at HAPILA including critical scale-up activities, the corresponding GMP manufacturing processes are established in the respective qualified plants; after successful completion of the process validation, and those for cleaning and testing methods, v...More info
Hapila GmbH provides wide range of pharmaceutical services which includes Particle Design. In the field of final finishing our know-how covers purification processes and technologies for physical conditioning of APIs. Thus, it can guarantee optimal bioavailability and improve specifically the galenic processi...More info
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