Chanelle Pharma has been sold by its founder Michael H Burke to Exponent, a European private equity firm.
Financial details of the deal have not been disclosed, but it is understood to be worth up to €300m.
Headquartered in Loughrea in Co Galway, Chanelle Pharma is the country's largest indigenous manufacturer of generic pharmaceuticals for animal and human health.
Founded in 1985 by Michael H Burke, Chanelle Pharma employs over 730 people in Ireland, the UK, Europe and Jordan. Mr Burke will now retire from the business.
The company services includes research and product development, registration and production of generic pharmaceuticals for both human and veterinary pharmaceuticals.
Exponent has a strong track record of transforming and growing the companies they invest in and it recently opened an office in Dublin.
It has made investments totalling over €1 billion in Irish-owned or Irish-based businesses to date. Chanelle Pharma is the firm's sixth platform investment in Ireland.
Under the terms of today's deal, Chanelle Pharma will remain an Irish managed company with the current management team remaining in place.
Michael H Burke, founder and managing director of Chanelle Pharma, said he has decided that the time is right to allow new owners to lead the company into its next phase of growth.
"I am very pleased that Exponent is acquiring Chanelle Pharma. They value the heritage of our company and share our ethos and vision. They have the expertise and resources to grow Chanelle Pharma with new investment across all our operations," he added.
David McGovern, Partner at Exponent, said the investment in Chanelle demonstrates its commitment to partner with market leading Irish businesses seeking to grow internationally and accelerate their growth.
"We look forward to working closely with Chanelle's management team to strengthen its global presence and invest in its capabilities," he said.
James Gunton, Partner at Exponent, said that Chanelle has established itself as a leading pharmaceutical manufacturer of both veterinary and medical products with an extensive portfolio of licenses.
"We see tremendous opportunity in the development pipeline and look forward to bringing new products to market, as well as continuing to invest in Research and Development in the years to come," he added.
The company's headquarters in Loughrea includes three manufacturing plants, four research and development centres, warehousing and offices.
Its Spot On manufacturing has FDA approval, allowing the company to export to the US.
The Loughrea site manufactures generic pharmaceuticals for export to over 90 countries and works with the biggest generic companies across the world.
Today's deal is subject to approval from the Competition and Consumer Protection Commission (CCPC).