PL Developments Receives FDA Approval for Omeprazole OTC

7 months ago

• PL Developments (PLD) has received FDA approval for its Omeprazole Magnesium Tablet, a generic version of Prilosec® OTC, to be manufactured in its Miami facility. • The approval marks PLD as the only US-based manufacturer of Omeprazole OTC, enhancing its role as a key supplier in the consumer healthcare market. • The US market for Omeprazole OTC sees approximately $550 million in annual retail sales, with PLD planning to start commercial shipments in early 2025.

PL Developments (PLD) has announced FDA approval for its Omeprazole Magnesium Tablet, an over-the-counter (OTC) equivalent to Prilosec® OTC. This approval allows PLD to manufacture and distribute the drug from its facility in Miami, FL, making it the sole US-based provider of Omeprazole OTC. The company anticipates commencing commercial shipments to its clients in early 2025.

Strategic Significance

According to PLD, securing FDA approval for Omeprazole OTC underscores the company's dedication and expertise in bringing complex products to market. Evan Singer, President of PLD, emphasized that this achievement reinforces their role as a comprehensive supply partner, committed to delivering high-quality, reliable consumer healthcare products.

Market Context

The market for Omeprazole OTC in the United States is substantial, with approximately $550 million in annual retail sales. PLD's entry into this market is expected to provide a competitive edge, leveraging its manufacturing capabilities and established distribution network.

About Omeprazole

Omeprazole is a proton pump inhibitor (PPI) used to treat frequent heartburn. By reducing the amount of acid produced in the stomach, it helps alleviate symptoms and promote healing of erosive esophagitis. The availability of an OTC version allows consumers to self-treat frequent heartburn without a prescription, providing convenient access to relief.

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