Ascendia Pharmaceutical Solutions Corporate Profile

Ascendia Pharmaceutical Solutions Corporate Profile

Ascendia Pharmaceutical Solutions
Ascendia Pharmaceutical Solutions
(formerly Ascendia Pharmaceuticals, Ascendia® Pharma)
661 US Highway One
North Brunswick, NJ 08902
United States
Phone: 732-638-4028
Website: http://www.ascendiacdmo.com
Ascendia Pharmaceutical Solutions (formerly Ascendia Pharmaceuticals) is a leading specialty CDMO that makes the Impossible Possible through a comprehensive suite of pre-formulation, formulation development, cGMP manufacturing, and ICH stability services for a variety of dosage forms using its proprietary enabling nanotechnologies, including nano-emulsions, nanosuspensions, nanoparticles, lipid nanoparticles, and amorphous solid dispersion technology platforms. The company built its foundation of success on its customer-centric culture that cultivates its BEST philosophy (Brilliant technology, Excellent service, Superior quality, and Trust).

Its North Brunswick, NJ 60,000 square-foot facility has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms, as well as Class 100,000 (ISO 8) manufacturing suites. 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, veterinary drugs, and nutraceuticals.

Ascendia Pharmaceutical Solutions delivers sophisticated formulations to enhance bioavailability and solubility using four proprietary nanotechnologies – AmorSol®, EmulSol®, LipidSol™, and NanoSol®.

COMPANY DESCRIPTION

Strategically located in the heart of the New Jersey Bioscience Center, Ascendia Pharmaceutical Solutions provides advanced U.S.-based CDMO services from discovery to commercialization. It has a proven track record in developing formulations for API screening and CTM, that helps in all phases for fast drug development. A fine mix of proprietary technologies, state of-the-art manufacturing suites, and a team of formulators and scientists with expertise and knowledge allows Ascendia Pharmaceutical Solutions to solve problems quickly.

Ascendia Pharmaceutical Solutions uses all GRAS (Generally Regarded As Safe) materials, to streamline formulation development that results in time and money savings. Ascendia Pharmaceutical Solutions is a rare U.S.-based CDMO with capabilities that include spray drying, aseptic fill finish, lyophilization, GMP-grade NETZSCH DeltaVita® 600 Gamma Vita equipment, and the Precision Nanosystems NanoAssembler™ Ignite™, NanoAssemblr™ Blaze+™, and NanoAssemblr™ GMP System. These expansive capabilities position it as expert in working with lipid nanoparticles (LNPs) and nanostructured lipid carriers (NLCs), among others.

COMPANY BACKGROUND

Founded in 2012, Ascendia Pharmaceutical Solutions offers a comprehensive suite of pre-formulation, formulation development, cGMP manufacturing, and ICH stability services for all dosage forms. Ascendia Pharmaceutical Solutions built its foundation of success on its customer-centric culture that exudes its BEST philosophy. This approach has led to Ascendia Pharmaceutical Solutions doubling in size in the past four years and being named to the prestigious Inc. 5000 list four consecutive years.

MARKETS SERVED/FACILITIES

Ascendia Pharmaceutical Solutions is headquartered in the New Jersey Bioscience Center, North Brunswick, NJ. Its 60,000 square-foot facility has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms, as well as Class 100,000 (ISO 8) manufacturing suites. 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, veterinary drugs, and nutraceuticals. The CDMO’s expertise and capabilities allow it to scale-up and optimize various dosage forms. In fact, Ascendia Pharmaceutical Solutions has a proven track record of developing new dosage forms that were previously unattainable. Its successes are why pharmaceutical companies have entrusted Ascendia Pharmaceutical Solutions with tech transfers that lead to cost and time benefits.

PRODUCTS, SERVICES & CAPABILITIES

Ascendia Pharmaceutical Solutions delivers sophisticated formulations to enhance bioavailability and solubility using four proprietary nanotechnologies – AmorSol®, EmulSol®, LipidSol®, and NanoSol®. Its state-of-the-art facility supports GLP and cGMP manufacturing in accordance with ICH guidelines. Drug development teams rely on Ascendia Pharmaceutical

Solutions for:

  • Pre-formulation services/screening
  • Formulation development
  • Proprietary nanotechnologies
  • ICH stability studies
  • Sterile and non-sterile manufacturing
  • Analytical services, QC and Micro testing
  • Clinical trial material supply
  • Niche commercial product manufacturing
Ascendia Pharmaceutical Solutions
Ascendia Pharmaceutical Solutions
(formerly Ascendia Pharmaceuticals, Ascendia® Pharma)
661 US Highway One
North Brunswick, NJ 08902
United States
Phone: 732-638-4028
Website: http://www.ascendiacdmo.com

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