Durham, NC – July 23, 2025 — MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value‑added drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Nintedanib Esylate Nanoparticle Tablets. This novel oral formulation was developed using MAA’s proprietary NanoCont™ technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

“We are pleased to receive IND clearance from the FDA for our second clinical‑stage asset,” said Anjani Jha, Founder and CEO of MAA Laboratories. “This achievement further validates the potential of our NanoCont™ platform to enable enhanced oral drug formulations that deliver meaningful clinical and development advantages.”

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Key Highlights

• IND clearance granted for Nintedanib Esylate Nanoparticle Tablets
• 505(b)(2) regulatory pathway confirmed for a Phase I BA/BE study in healthy volunteers
• Developed using NanoCont™, an FDA‑recognized Emerging Technology
• Designed to optimize pharmacokinetics, patient experience, and systemic exposure
• Supports a modernized approach to oral formulation development

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About Nintedanib Esylate Nanoparticle Tablets

MAA’s next‑generation formulation of Nintedanib Esylate is designed to address limitations associated with conventional oral formulations. By leveraging the NanoCont™ platform, the tablet aims to improve absorption, enhance pharmacokinetic consistency, and support better patient adherence across its targeted indications.

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Corporate Office
MAA Laboratories, Inc.
400 Park Offices Drive
Suite# 214
Durham, NC 27709
United States of America
? Email: info@maalaboratories.com
? Phone: 919.271.7868