PL Developments (PLD), a leader in the development, manufacturing, packaging, and distribution of consumer healthcare products, announced two significant milestones: FDA approval for its Omeprazole OTC ANDA and the successful refinancing of its corporate debt.

FDA Approval for Omeprazole OTC

The FDA has granted approval for PLD's Omeprazole Magnesium Tablet, a product comparable to Prilosec^® OTC. The product will be manufactured at PLD's facility in Miami, FL, making PLD the only provider of Omeprazole OTC produced in the United States. This achievement underscores the company's extensive capabilities to develop, manufacture, and commercialize some of the most complex products offered in the US consumer healthcare market.

"Receiving FDA approval for Omeprazole OTC is a significant achievement for our organization," said Evan Singer, President of PLD. "This accomplishment not only highlights our team's dedication and expertise in bringing complex products to market, but it also reinforces our role as a comprehensive supply partner for our customers. Our goal is to offer a wide assortment of consumer healthcare products that meet the highest standards of quality and reliability. We are committed to delivering value and consistency to our partners in an ever-evolving marketplace."

The market for Omeprazole OTC in the United States is robust, with retail sales of approximately $550 million annually. PLD expects to commence commercial shipments of Omeprazole to its clients in early 2025.