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.
Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); East Asia (e.g. China, Japan, Korea); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South Asia (e.g. India, Pakistan, Sri Lanka); South East Asia (e.g. Thailand, Philippines, Singapore)
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