Products

Product Pipeline

Powered by NanoCont™: Precision Reformulation for Global Impact

At MAA Laboratories, we are advancing a pipeline of next-generation drug products using our proprietary NanoCont™ platform—a cutting-edge, nanoparticle-based drug delivery and continuous manufacturing technology. NanoCont™ is designed to transform proven molecules into clinically meaningful, patent-protected therapies that overcome long-standing challenges in formulation, tolerability, and scalability.

Our internal pipeline focuses on reformulating established active pharmaceutical ingredients (APIs) to improve bioavailability, reduce dose-related toxicity, and enable patient-friendly dosage forms—without the need for extensive clinical development.

? Lead Development Programs

Methotrexate Nanoparticle Tablets

Target Indications: Autoimmune diseases and Oncology
Regulatory Pathway: 505(b)(2) in the U.S., Hybrid (EU), NDS (Canada)
An oral, once-daily methotrexate formulation developed to improve GI tolerability, reduce dose-related side effects, and minimize patient variability. Designed for both oncology and autoimmune conditions, this candidate addresses key limitations of existing methotrexate formulations while maintaining therapeutic effectiveness.

Nintedanib Esylate Nanoparticle Tablets

Target Indications: Idiopathic Pulmonary Fibrosis (IPF), Progressive Fibrotic Lung Disease
Regulatory Pathway: 505(b)(2) in the U.S., Hybrid (EU), NDS (Canada)
A reformulated version of nintedanib developed to enhance bioavailability, reduce food-effect sensitivity, and potentially enable lower dosing. This product is intended to improve patient adherence and therapeutic consistency in long-term use settings, including chronic fibrotic lung diseases.

Dasatinib Nanoparticle Tablets

Target Indications: Chronic Myeloid Leukemia (CML), Acute Lymphoblastic Leukemia (ALL)
Regulatory Pathway: 505(b)(2) in the U.S., Hybrid (EU), NDS (Canada)
An optimized oral dasatinib formulation aimed at reducing systemic exposure, maintaining efficacy at lower doses, and minimizing off-target toxicity. Designed to support long-term treatment and potential use in pediatric or combination regimens.

? Streamlined Clinical Strategy

All MAA Laboratories products are being developed using bioavailability/bioequivalence (BA/BE) studies in healthy volunteers only—with no new safety, efficacy, or toxicity studies required. This is made possible by leveraging the 505(b)(2) regulatory pathway in the U.S., along with Hybrid Applications in Europe, New Drug Submissions (NDS) in Canada, and equivalent regulatory pathways in other global markets.

This regulatory strategy allows us to:

  • Reduce development time and clinical risk

  • Avoid costly and time-consuming efficacy trials

  • Focus solely on demonstrating formulation superiority and bioequivalence

  • Accelerate global regulatory submissions and approvals

All three lead programs are backed by clinical strategies already reviewed and accepted by the U.S. FDA, reflecting strong regulatory alignment.

? Global IP & Regulatory Engagement

  • NanoCont™ is patented in major global markets, including the United States, with additional applications pending worldwide.

  • Recognized by the U.S. FDA as part of the Emerging Technology Program, and reviewed by multiple FDA divisions

  • Scientific and regulatory reviews also conducted by Health Canada and European regulatory agencies

  • Global regulatory outreach to additional health authorities is actively underway

? Commercial & Labeling Strategy

In parallel with development, MAA Laboratories has established a strategic framework for label claim enhancementsand commercial positioning, designed to meet the expectations of partners, payors, and prescribers.

NanoCont™-enabled products may support differentiated claims such as:

  • Reduced dose-related side effects

  • Improved tolerability and patient adherence

  • Minimized or eliminated food-effect interactions

  • Lower inter-patient variability

  • More convenient oral dosage forms (e.g., tablet or capsule vs. injectable)

These claims are supported by scientific rationale, pharmacokinetic modeling, and are tailored to partner-specific commercialization strategies.

? Partner With Us

In addition to advancing our internal pipeline, MAA Laboratories partners with pharmaceutical companies, innovators, and regional distributors to co-develop and commercialize NanoCont™-enabled products—whether through reformulation of existing molecules or formulation of pipeline assets.

? For licensing and co-development opportunities, contact our Business Development team:
? BD@maalaboratories.com