ADPEN Pharmaceuticals

CONTRACT FORMULATION DEVELOPMENT
AND MANUFACTURING

Quality and Excellence
for a Healthier World

ADPEN PHARMACEUTICALS

A division of ADPEN Laboratories, Inc. located in Florida, with over 30 years providing analytical services to the pharmaceutical industry has expanded its operations from a Contract Research Organization (CRO) to also a Contract Manufacturing Organization.

CONTRACT MANUFACTURING

Our team can offer complete guidance, including from a regulatory standpoint, for the development and manufacturing of your pharmaceutical product. We have a comprehensive and full-service operation for clinical trial materials preparation in support of Phase I – III development as well as for commercial scale-up and manufacturing of API, solid, liquid, semi-solid and parental dosage forms, sterile and non-sterile. Our services are cGMP compliant and include established protocols, efficient documentation practices, ISO 17025 accreditation, DEA license and effective QA management. We can be your greatest resource.

FORMULATION

Formulation development for new chemical (NCE) and new biological (NBE) entities and generic OTC and Rx. Optimization of existing formulations
Process development for specific dosage forms
Improving delivery of existing dosage forms
Developing controlled release, sustained release, and complex formulations
Dedicated suites for the handling of DEA Scheduled Compounds

MANUFACTURING

Support of clinical-niche
commercial manufacturing
Quality Control.

ANALYTICAL SERVICES

ADPEN offers a broad range of analytical services, stability, microbiological, physical, biochemical and chemical, improcess and batch release testing. Development, validation and transfer of methods.

PARTNERS

We are open to opportunities for partnerships that will help advance our pipeline and achieve our mission to develop and commercialize generic Rx and Novel drugs by translating innovative science into generic and new medicines that improve patients’ lives.

If you would like to find out more, please email us at: rp@adpen.com