Allegan-based Perrigo Co. (Nasdaq: PRGO) announced that it had achieved “acceptable regulatory status” in a re-inspection of its Allegal manufacturing plant by the Detroit office of the United States Food and Drug Administration.
The inspection also means that any pending export license and ANDA applications from this facility will once again be eligible for review and approval.
Said Perrigo chairman and CEO Joseph C. Papa: “On behalf of Perrigo, I want to thank the FDA Detroit District for making the re-inspection of our facilities a priority and for working cooperatively with us to resolve the issues previously raised in the Warning Letter. We are convinced that this process has made us a better company by enhancing the quality of our affordable healthcare products for our customers.”
Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients and pharmaceutical and medical diagnostic products. The company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. Perrigo’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.