MAA Laboratories Receives FDA IND Clearance for Nintedanib Esylate Nanoparticle Tablets Developed with NanoCont™ Technology

On July 13, 2025 MAA Laboratories Inc., a specialty pharmaceutical company focused on developing value-added and clinically differentiated drug products, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Nintedanib Esylate Nanoparticle Tablets, developed using the company’s proprietary NanoCont technology platform (Press release, MAA Laboratories, JUL 23, 2025, View Source [SID1234654481]).

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This regulatory milestone enables MAA Laboratories to initiate its Phase I clinical trial in healthy volunteers under the FDA’s 505(b)(2) regulatory pathway.

"We are pleased to receive IND clearance from the FDA for our second clinical-stage product," said Anjani Jha, Founder and CEO of MAA Laboratories. "This milestone continues to validate the potential of our NanoCont platform to deliver enhanced oral drug products with meaningful clinical and development advantages."