CMC Development

AdhexPharma’s ambition is to be recognised as the most competent and successful developer and manufacturer of transdermal (TDS), topical delivery systems and oral thin films (OTF).

The company can help if you are:

• Looking for a drug delivery partner to evaluate your drug candidate for the transdermal, topical or oral route
• Willing to work on a line extension or product differentiation for your existing drug products portfolio
• Searching to improve the delivery route of your existing drug product
• Looking to manufacture your lead candidate for formula in a current good manufacturing practice (cGMP) environment for clinical supply

The company is 100% focused on meeting its clients’ needs. AdhexPharma will be your preferred partner at any stage of your Product CMC development. It helps with:

• Early stage development – Evaluation of your Drug Substance physicochemical characteristics for a TDS or OTF drug delivery. It conducts formulation and analytical development and pre-stability studies, as well as in-vitro and ex-vivo proof of concept studies.
• Clinical stage – Offerings include technical and scale-up batches, clinical batch manufacture and release and ICH stability studies.
• Comercial Stage – Registration and  process validation batches, as well as commercial production.
• Regulatory expertise – The company provides CMC writing and pre-clinical evaluation for safety and efficacy aspects

AdhexPharma considers that each project is unique and it manages them as such, following the above development approach in a flexible manner.