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GMP Manufacturing

GMP Manufacturing

Formurex has the capacity to support Phase 1 Clinical Trial Materials (CTM) for Sponsors in Oral solids, Oral liquids, and Topical dosage forms. Our team has the technical expertise and pharmaceutical experience to formulate, scale up, tech transfer, and manufacture clinical supplies for use in first-in humans. Formurex has an excellent quality system in place in addition to the Quality Assurance (QA) system. Our facility has the capacity to supply up to 10,000 tablets or 5,000 capsules per day. Formurex has the capability to manufacture controlled substances (Class II to Class V) and potent substances.

Formurex helps Sponsors in the regulatory submissions such as Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA), Marketing Authorization Application (MAA), and Abbreviated New Drug Application (ANDA).