Ascendia Pharmaceuticals®
661 US Highway One, Unit B
North Brunswick, NJ 08902
T: (732) 638-4028


Ascendia Pharmaceuticals® is a specialty formulation CDMO for biologicals and gene deliveries, as well as small molecules. It provides custom sterile and non-sterile enabling formulations, along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product development, as well as OTCs and nutraceuticals.

Ascendia continues to expand its people, capabilities, and facilities to exceed customer expectations from pre-formulation through to commercialization. This investment allows Ascendia to continue be expert in sophisticated formulations, and well as cGMP sterile and non-sterile clinical trial and commercial manufacturing. Many clients have anointed Ascendia a “Partner of Choice” because of the successes it has achieved for them.

Ascendia’s formulation experts make the Impossible Possible by developing formulations for projects when others have failed. These successful formulations use all GRAS materials to eliminate regulatory burden.

Company Background

Founded in 2012, Ascendia offers a comprehensive suite of pre-formulation, formulation development, cGMP manufacturing, and ICH stability services for all dosage forms using proprietary nanotechnologies in nanoemulsion, nanoparticles, and amorphous technology platforms. The company built its foundation of success on its customer-centric culture that exudes its BEST philosophy (Brilliant technology, Excellent service, Superior quality, and Trust).

Markets Served/Facilities

Headquartered in North Brunswick, NJ, Ascendia’s 60,000 square-foot facility has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms, as well as Class 10,000 (ISO 7) manufacturing suites. Ascendia’s expertise in discovering the most effective formulation development for poorly soluble molecules and biologics aligns the CDMO with pharmaceutical and biopharmaceutical companies developing new drugs, as well as new formulations for existing drugs for new uses.

Products, Services & Capabilities

Ascendia delivers sophisticated formulations to enhance bioavailability and solubility using four proprietary nanotechnologies – AmorSol®, EmulSol®, LipidSol®, andNanoSol®. It develops solutions for all dosage forms for small molecules and biologics, including lipid nanoparticles that enable gene therapy. Its facility maintains stability chambers for conducting non-GMP and cGMP stability studies in accordance with ICH guidelines. Ascendia stability studies:

  • determine robustness of formulation prototypes during early development
  • ascertain chemical and physical integrity of lead formulations before advancement into animal/toxicology studies
  • ensure final formulations meet stability for clinical trials

Ascendia offers fast, flexible, and small-batch size services for conducting first-in-man study efficiently to stay on schedule and within budget.