PL Developments receives FDA approval for over-the-counter omeprazole
PL Developments, which develops and manufactures consumer healthcare products, has received the Food and Drug Administration’s approval for its omeprazole OTC.
Omeprazole magnesium tablet, a product comparable to Prilosec OTC, will be manufactured at PLD's facility in Miami, making PLD the only provider of omeprazole OTC produced in the United States, the company noted.
This achievement underscores the company's extensive capabilities to develop, manufacture and commercialize some of the most complex products offered in the U.S. consumer healthcare market, PLD said.
"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 is approximately $550 million annually. PLD expects to commence commercial shipments of Omeprazole to its clients in early 2025.
PLD also announced the successful completion of its offer to exchange $350,000,000 aggregate principal amount of its outstanding 7.750% Senior Secured Notes. This strategic move was made possible through improved financial performance and a collaborative effort with key stakeholders. The completion of the Exchange Offer enhances the company's financial flexibility and positions it for continued growth and strategic investments.
“In addition, we previously entered into a commitment letter with certain holders of the Old Notes pursuant to which we expect to issue and sell to such holders in a private transaction additional New Notes in an aggregate principal amount of $131,450,000 (the 'Concurrent Financing'). The proceeds from the Concurrent Financing will be used to repay the remaining amounts of Old Notes outstanding and to pay certain fees and expenses in connection with the Exchange Offer and the Concurrent Financing,” the company said.
"The successful consummation of the Exchange Offer is a strong affirmation of PLD's financial health and growth trajectory," said Asaph Naaman, chief financial officer. "This achievement reflects our focus on operational efficiencies, free cash flow generation, and building strong relationships with external stakeholders. We are now well-positioned to capitalize on future opportunities and continue our upward momentum."
The New Notes issued in the Exchange Offer have not been and the New Notes that will be issued in the Concurrent Financing will not be registered under the Securities Act, or any other applicable securities laws. This press release is for informational purposes only and is neither an offer to purchase the Old Notes nor a solicitation of an offer to sell the New Notes.