Tulex Pharmaceuticals


Tulex Pharmaceuticals is a technology-driven specialty pharmaceutical company committed to delivering optimal drug delivery solutions to patients. Located in Cranbury, New Jersey, the company focuses on developing and manufacturing clinically differentiated products at affordable prices through specialized drug delivery technologies. With a state-of-the-art cGMP facility, Tulex offers comprehensive services from early development to commercial manufacturing, leveraging advanced platforms like GREAT and BEST. The leadership team has extensive industry experience, with a strong emphasis on quality, innovation, and strategic partnerships.

Industries

biotechnology
marketing-2795
medical
pharmaceutical
product-research

Nr. of Employees

small (1-50)

Tulex Pharmaceuticals

Cranbury, New Jersey, United States, North America


Patents

Desmopressin oral compositions

US-12343372-B2

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Compositions and methods for treating epilepsy, seizures and other conditions

US-12290503-B2

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Desmopressin oral compositions

US-12214010-B2

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Hydrocortisone oral liquid formulations

US-12133914-B2

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Compositions and methods for treating epilepsy, seizures and other conditions

US-11911362-B2

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Compositions and methods for treating epilepsy, seizures and other conditions

US-11826343-B2

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Products

Gradient Release Enabling

An advanced oral drug delivery technology and programmable platform designed for delivery to specific sites in the GI tract, featuring targeted release matrices, pellets, and liquid dosage forms.

Controlled release matrix pellets

Modified and controlled release matrices, pellets, and liquid dosage forms designed for better patient adherence, efficacy, and reduced adverse effects.

CDMO and CMO Services

Comprehensive CDMO solutions from early-phase development to commercial manufacturing, specializing in innovative and complex drug delivery for oral administration.

High drug loading palletization

Proprietary technology for high drug loading matrices and pellets designed to reduce pill burden for high dose drugs, enhance bioavailability, and provide efficient processing with temperature control.

Innovative Pelletizing Technology

Proprietary loading technology that achieves high dense drug loaded particles by incorporating the drug on core spheres and/or layering onto inert spheres through a high impact process.

Multi-Purpose Laboratory Fluid Bed System 500 g to 3 Kg

Laboratory fluid bed system for batch sizes ranging from 500 g to 3 Kg.

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Services

Integrated services from pre-formulation R&D through process development, scale-up, clinical-batch manufacture and commercial production for oral dosage forms.

Analytical method development, validation, stability testing, impurity and elemental impurity testing, extractables/leachables and release testing using a range of high‑resolution instrumentation.

Preparation and support for regulatory filings including NDA and ANDA submissions, CMC documentation, and compliance with FDA/DEA/EPA/OSHA standards.

In-house packaging design and commercial packaging operations integrated with manufacturing workflows to prepare products for distribution.

Project planning and execution across development and manufacturing stages including milestone tracking and cross-functional coordination.

Expertise Areas

  • Pharmaceutical formulation and process development
  • Oral solid and liquid dosage form manufacturing
  • Analytical method development and QC testing
  • cGMP manufacturing and quality systems
  • Show More (4)

Key Technologies

  • cGMP manufacturing
  • Wet nano-milling / particle size reduction
  • Multiparticulate coating for programmed release
  • High-drug-load pelletizing
  • Show More (6)

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