How to Setup a Generic Drug Manufacturing Plant: Business Plan

IMARC Group’s “Generic Drug Manufacturing Plant Project Report 2025: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue” report provides a comprehensive guide on how to successfully set up a generic drug manufacturing plant. The report offers clarifications on various aspects, such as unit operations, raw material requirements, utility supply, infrastructural needs, machinery models, labour necessities, transportation timelines, packaging costs, etc.

In addition to the operational aspects, the report also provides in-depth insights into generic drug manufacturing plant cost, project economics, encompassing vital aspects such as capital investments, project funding, operating expenses, income and expenditure projections, fixed and variable costs, direct and indirect expenses, expected ROI, net present value (NPV), profit and loss account, and thorough financial analysis, among other crucial metrics. With this comprehensive roadmap, entrepreneurs and stakeholders can make informed decisions and venture into a successful generic drug manufacturing unit.

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What is Generic Drug?

A generic drug is a medication that has the same active ingredients, strength, dosage form, and route of administration as a brand-name drug, but is sold under its chemical name rather than a brand. Generic drugs are approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) after proving their bioequivalence to the original branded counterpart, meaning they deliver the same therapeutic effect in the body. These drugs are typically manufactured after the patent protection of the branded drug expires, making them a more affordable alternative for patients and healthcare systems. While generic drugs are chemically identical to their branded versions, they may differ in color, shape, packaging, and inactive ingredients. Due to rigorous approval processes, generics are considered just as safe and effective. Their lower cost and widespread availability have made them a vital component in improving public access to essential medicines around the world.

Market Trend and Drivers of Generic Drug:

The generic drug market is being driven by a combination of economic, regulatory, and healthcare factors. One of the primary drivers is the expiration of patents on blockbuster branded drugs, which opens the door for generic versions to enter the market at significantly lower prices. Additionally, rising healthcare costs are prompting governments and private insurers to encourage the use of generics to contain pharmaceutical spending. Regulatory support and streamlined approval processes in countries like the U.S., India, and the EU have further accelerated generic drug production. The increasing prevalence of chronic diseases such as diabetes, hypertension, and cancer has also boosted demand for cost-effective medications. Moreover, growing awareness about affordable healthcare and the expanding presence of retail pharmacy chains in emerging markets are fostering accessibility. Pharmaceutical companies are now also investing in biosimilars—generic versions of biologics—broadening the scope of the market. Collectively, these factors are fueling growth and innovation in the generic drug industry.

Key Aspects to Setup a Generic Drug Plant:

Location to Setup Plant
Market Research
Plant Layout
Construction and Infrastructure
Equipment/Machinery Procurement
Documentation and Licenses
Cost Analysis

Requirements to Setup a Facility:

Types of Costs to Setting up a Generic Drug Factory:

Land, Location and Site Development Cost
Plant Layout Cost
Machinery Requirements and Costs
Raw Material Requirements and Costs
Packaging Requirements and Costs
Transportation Requirements and Costs
Utility Requirements and Costs
Human Resource Requirements and Costs

Project Economics:

Capital Investments
Operating Costs
Expenditure Projections
Revenue Projections
Taxation and Depreciation
Profit Projections
Financial Analysis

Key Questions Answered in the Report:

How has the generic drug market performed so far and how will it perform in the coming years?
What is the market segmentation of the global generic drug market?
What is the regional breakup of the global generic drug market?
What are the price trends of various feedstocks in the generic drug industry?
What is the structure of the generic drug industry and who are the key players?
What are the various unit operations involved in a generic drug manufacturing plant?
What is the total size of land required for setting up a generic drug manufacturing plant?
What is the layout of a generic drug manufacturing plant?
What are the machinery requirements for setting up a generic drug manufacturing plant?
What are the raw material requirements for setting up a generic drug manufacturing plant?
What are the packaging requirements for setting up a generic drug manufacturing plant?
What are the transportation requirements for setting up a generic drug manufacturing plant?
What are the utility requirements for setting up a generic drug manufacturing plant?
And more…

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How IMARC Can Help?

IMARC Group is a global management consulting firm that helps the world’s most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

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