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
Nr. of Employees
small (1-50)
Tulex Pharmaceuticals
5 Cedar Brook Dr. Cranbury, New Jersey 08512
Patents
Compositions and methods for treating epilepsy, seizures and other conditions
US-12290503-B2
View DetailsCompositions and methods for treating epilepsy, seizures and other conditions
US-11911362-B2
View DetailsCompositions and methods for treating epilepsy, seizures and other conditions
US-11826343-B2
View Details
Compositions and methods for treating epilepsy, seizures and other conditions
US-12290503-B2
View DetailsCompositions and methods for treating epilepsy, seizures and other conditions
US-11911362-B2
View DetailsCompositions and methods for treating epilepsy, seizures and other conditions
US-11826343-B2
View DetailsServices
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.
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
Key Technologies
- cGMP manufacturing
- Wet nano-milling / particle size reduction
- Multiparticulate coating for programmed release
- High-drug-load pelletizing