Generic Drug Product Development
molkem.comArticle
Generic drug product development is a structured process for developing medicines that demonstrate pharmaceutical equivalence and bioequivalence with authorized reference products. The process encompasses reference-product strategy, formulation and process development, analytical methods, stability testing, scale-up, and dossier preparation-differing from new-drug development because the therapeutic use of the active ingredient is already established. Development is best managed as connected workstreams across seven stages: product and market feasibility, reference-product strategy, product design, formulation/analytical/stability development, process development and scale-up, equivalence evidence generation, and dossier readiness. The reference product serves as a benchmark for assessing pharmaceutical and performance characteristics; comparator procurement and characterization must follow a documented plan with traceability of source, batch, expiry, and storage history. An evidence-led development plan improves scientific and submission readiness but does not guarantee regulatory acceptance.
#pharmaceutical formulation#generic drug#bioequivalence#regulatory#india













