Glossary

A submission to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of a previously approved branded drug.

Testing performed under extreme storage conditions (e.g., high temperature and humidity) to forecast long-term stability and establish a preliminary shelf-life for a drug substance more quickly.

The principle of assuming full responsibility for project outcomes, adhering to defined quality, timeline, and regulatory requirements outlined in a service agreement.

The biologically active component within a drug product responsible for its intended therapeutic effect.

The capability to quickly and efficiently adapt to changing project demands, including shifts in production scale, synthetic routes, or regulatory feedback. This adaptability is a core operational value at Neuland.

A comprehensive cGMP document providing a detailed and traceable history of the production of a single batch of material.

Refers to the fraction of an administered drug dose that reaches the systemic circulation in active form, becoming available to produce the intended therapeutic effect.

The use of natural catalysts, such as enzymes, to perform chemical transformations, often resulting in highly selective, efficient, and sustainable manufacturing processes.

A service provider to the pharmaceutical industry offering a comprehensive suite of services from process development and clinical trial manufacturing to commercial production.

A set of regulatory standards and practices governing the design, monitoring, and control of manufacturing processes and facilities to ensure the consistent quality and safety of pharmaceutical products.

A critical purification and isolation step in which a solid, crystalline material is formed from a solution to achieve desired physical properties like particle size, purity, and polymorphic form.