GMP Manufacturing

Formurex has the capacity to support Phase 1 Clinical Trial Materials (CTM) for sponsors across oral solid, oral liquid, and topical dosage forms. Our team combines technical expertise with extensive pharmaceutical experience to formulate, scale up, tech transfer, and manufacture clinical supplies for first-in-human studies. We operate under a robust quality system, reinforced by a dedicated Quality Assurance (QA) framework, ensuring compliance and reliability at every stage. Our facility is equipped to produce up to 10,000 tablets or 5,000 capsules per day, and we are fully capable of handling controlled substances (Class II to V) as well as potent compounds.

In addition, Formurex supports sponsors in preparing regulatory submissions, including Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA), Marketing Authorization Application (MAA), and Abbreviated New Drug Application (ANDA).