International Journal of Drug Delivery Technology
Volume 15, Issue 1

Generic Product Development and Reverse Engineering of Reference-Listed Drug Product 

Kathpalia H1*, Aiyer M1, Mondkar T1, Dali P2

1Department of Pharmaceutics, Vivekanand Education Society's College of Pharmacy, (Autonomous), Affiliated to University of Mumbai, Hashu Advani Memorial Complex, Chembur, Mumbai, 400 074, Maharashtra, India.

2 Insitus Solutions, Borivali, Mumbai, Maharashtra, 400066, India

Received: 16th Jun, 2024; Revised: 13th Dec, 2024; Accepted: 30th Dec, 2024; Available Online: 25th Mar, 2025

ABSTRACT

Generic drugs play a vital role in ensuring equitable and affordable access to healthcare across the world. It refers to the development of a product that is equivalent in terms of both pharmaceutical and therapeutic properties to a Reference Listed Drug product, and that is then reverse-engineered to create a generic version.  Systematic desk research, characterization and finally de-formulation of Reference Listed Drug are preliminary steps towards pharmaceutical development of generic product. De-formulation is the process of separating, identifying, and quantifying each individual component in a drug product. With the same ingredients (Q1), amounts (Q2), and physicochemical properties (Q3) as the Reference Listed Drug product for which the generic version is to be developed, de-formulation generates vital data for generic pharmaceutical products. To guarantee Q1 and Q2 sameness, sophisticated methods like Raman imaging can detect and measure the components of the innovator drug products. Various methodologies created using a variety of analytical techniques that accurately reveal information about the excipients, active pharmaceutical elements, and manufacturing process are discussed in this review.

How to cite this article Kathpalia H, Aiyer M, Mondkar T, Dali P. Generic Product Development and Reverse Engineering of Reference-Listed Drug Product. International Journal of Drug Delivery Technology. 2025;15(1):351-58. doi: 10.25258/ijddt.15.1.48

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