FDA Registered Manufacturing Facility

Business Overview:

South Dakota Partners is Contract Manufacturing Organization for sale in the Midwest. The company is a packager and producer of private white label devices and is registered with FDA as a contract manufacturer and as an importer of medical devices. With decades of experience as medical device contract manufacturers for some of the most recognized brands in the industry, they work with their clients on every level of the medical device manufacturing process — from upfront manufacturing and engineering to post-production assembly, kitting, quality/testing, repair, and distribution. The majority of SDP’s revenue is derived from supply agreements with its customers. Gross revenue was nearly $13 million in 2023, and they were highly profitable with a Net Ordinary Income of $1.4 million. They expect to see similar results in 2024 and continue to grow their pipeline of customers. The staff is expected to remain under new ownership. The sellers will assist during a transitional period as needed. The asking price for this opportunity is $1 million.

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Market Competition and Expansion:

SDP provides services to medical device companies with global operations. The majority of customer orders are concentrated in the United States, where the healthcare industry is experiencing rapid growth, driven by an aging population, particularly those aged 65 and above. The resilience of the US healthcare sector, often considered recession-proof due to the critical nature of its services, further underscores its appeal.

In the United States, both the facilities manufacturing medical devices and the devices themselves must receive clearance from the FDA. Recognizing the importance of compliance, SDP has engaged FDA regulatory experts to ensure that both facilities and products meet all relevant regulations within the US medical device space.

SDP's sales strategy relies on its reputation, word of mouth referrals, and established industry contacts. There is potential for growth through contracts with additional healthcare companies, particularly as a Contract Manufacturing Organization (CMO).

Reason for Selling:

Strategic Change

Additional Details:

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