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.
Company Information
PL Developments, founded in 1988 and headquartered in Westbury, NY, is a developer, manufacturer, packager, and distributor of consumer healthcare products. It operates pharmaceutical manufacturing facilities across the United States and offers over 450 unique products across several healthcare categories.
