HAPILA GmbH services

We have set ourselves the goal of only selling products of high quality, effectiveness and safety in compliance with the legal requirements for environmental protection and occupational safety.

We have decades of experience in the development of chemical syntheses for active pharmaceutical ingredients which enables us to offer our customers a wide range of chemical process developments including the associated analytical development.

We are a reliable partner in the GMP area and, with many years of experience, manufacture high-quality active ingredients for pharmaceutical applications - regardless of whether as an in-house development or as a one-to-one transfer of your manufacturing process: We use our long-standing experience in the field of chemical synthesis processes to scale up your process and for the manufacture of chemical products at the Gera site.

The company specializes in the production of chemical-pharmaceutical active ingredients, focusing on the synthesis of isotope-labelled substances for in-vitro diagnostics. Utilizing non-radioactive stable isotopes like 2H, 13C, and 15N allows for safe and accurate elucidation of active ingredient metabolism. This capability is critical for researchers and professionals needing precise insights into molecular interactions and metabolic pathways. The company aims to address challenges such as the production of interesting molecules with promising applications, providing solutions for situations where reliable manufacturing partners are necessary or where existing production volumes are insufficient. Their approach maintains a focus on customization and scalability, ensuring that clients' specific requirements are met efficiently.

The company provides extensive quality control services, focusing on synthesis development and GMP manufacturing, alongside a wide array of both instrumental and wet-chemical analytics services. These services encompass identity, purity, and content testing, which include stability tests. Their comprehensive portfolio ranges from the creation of specifications for active pharmaceutical ingredients in alignment with ICH Q6A guidelines, to routine analyses adhering to validated pharmacopoeial methodologies. Furthermore, they specialize in the development and validation of analytical methods for active ingredients, intermediates, and regulatory starting materials. A noteworthy component of their quality control tasks is the evaluation of active pharmaceutical ingredient stability through chemical-physical stress tests and formal stability studies, which are conducted in accordance with ICH Q1A/Q1E or Q1B standards to ensure product stability. The company employs advanced, qualified analytical devices to execute these critical analyses effectively.