FEASIBILITY ANALYSIS OF BUSINESS DEVELOPMENT OF BA-BE TEST LABORATORY FOR PHARMACEUTICAL INDUSTRY OF PT X

• Main Author: Widiastuti, Endang
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/40228
• Institution: Institut Teknologi Bandung

The Pharmaceutical Industry (PI) in Indonesia mostly produces generic drugs so that the focus is on formulation activities. In order for interchangeable generic drugs or certain preparations to be equivalent to the innovator. To assess bioquivalence, a bioavailability and bioequivalence test (BA-BE) is needed, which is generally one of the obstacles to developing generic drugs. This study aims to analyze the business development of the BA-BE test Laboratory (Lab) by PI PT X. The research method used is descriptive analytic with PI subjects who have mandatory drugs BA-BE test more than 10 items that do not have the BA-BE Test Lab and BPOM using a questionnaire. Secondary data is obtained based on internet browsing and IMS Health. Data were analyzed descriptively and analytically using business feasibility parameters namely NPV, IRR, and PBP with the scheme of 3 scenarios were worst case, base case and best case. The results showed that the drugs that needed a BA-BE test per year were 332 items, while the capacity of the BA-BE test Lab was 240, so Lab BA-BE is still needed to be developed. Based on the feasibility analysis using three scenarios obtained a positive NPV value; IRR value is greater than WACC; and PBP from the three scenarios are 5.57 years, 5.35 years and 5.29 years. From the results above, the BA-BE Lab for PT X is still necessary and feasible to be developed.