Clinical Trials
0
0 active
Approvals
12
Total approvals
Agencies
1
Regulatory bodies
Founded
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No trial phase data available
No trial data available
No trial data available
• PL Developments (PLD) has secured FDA approval for its over-the-counter omeprazole magnesium tablet, comparable to Prilosec OTC. • PLD will manufacture the omeprazole OTC product in its Miami facility, becoming the only U.S.-based provider. • Commercial shipments of Omeprazole to PLD's clients are expected to commence in early 2025, targeting the $550 million market. • PLD also completed an exchange offer, enhancing financial flexibility for continued growth and strategic investments.
• PL Developments (PLD) received FDA approval for its Omeprazole Magnesium Tablet, an OTC product comparable to Prilosec® OTC, manufactured in their Miami facility. • The approval allows PLD to be the only US-based manufacturer of Omeprazole OTC, addressing a market with approximately $550 million in annual retail sales. • PLD successfully refinanced its corporate debt by exchanging $350 million in senior secured notes for $368.55 million in new notes, enhancing financial flexibility. • Commercial shipments of Omeprazole are expected to begin in early 2025, expanding PLD's portfolio of over 450 consumer healthcare products.
• PL Developments (PLD) has received FDA approval for its Omeprazole Magnesium Tablet, a generic version of Prilosec® OTC, expanding its consumer healthcare product line. • PLD will manufacture the Omeprazole OTC product at its Miami facility, becoming the only US-based provider of this medication, with commercial shipments expected in early 2025. • The US market for Omeprazole OTC is substantial, with annual retail sales of approximately $550 million, presenting a significant opportunity for PLD. • PLD also completed a corporate debt refinancing, enhancing financial flexibility for future growth and strategic investments.
• 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.
