What are the main stages of the generic drug development process?

Author : first copy | Published On : 16 Sep 2026

The generic drug development process generally includes reference product evaluation, preformulation, formulation and analytical development, process development, scale-up, stability testing, bioequivalence studies, and regulatory submission. During generic drug product development, the reference medicine is studied, and a suitable formulation is developed to meet required quality and performance standards. For generic product development, testing focuses on factors such as dissolution, stability, assay, impurities, and bioequivalence. The pharmaceutical generic product development process may vary depending on the dosage form, API, regulatory requirements, and target market, so the generic drug development timeline can differ for each product.