Corridor · Sourcing Intelligence
Akunudo screens manufacturers of Artemether-Lumefantrine 20/120mg for United Arab Emirates registration before you ever see them — certification, stability zone for the climate, and dossier format clear first; commercial fit second. Identities stay sealed until NDA, so you can source without tipping your hand.
1
vetted manufacturer
—
EU-GMP listed
60
top alignment
Not a directory to wade through — a brokered, anonymized corridor. We only fully win when your deal closes.
Market access · United Arab Emirates
The Emirates Drug Establishment (EDE) is now the UAE federal authority for product registration, marketing authorisation and pricing — created by Federal Decree-Law 38/2024 (in force Jan 2025), with MoHAP's 44 core drug services transferred to EDE in January 2026 (MoHAP retains only narcotics-related functions). Registration is via the EDE portal with a GCC-aligned CTD and a UAE-licensed importer of record; a reliance model leans on FDA/EU approvals with a fast-track for innovative/critical-care products. Prices are set by external reference pricing and EDE is actively repricing (a 2026 EDE decision cut 168 chronic-disease medicines by up to ~60%).
The Emirates Drug Establishment (EDE), the federal authority created by Federal Decree-Law 38/2024 (in force Jan 2025); MoHAP transferred its core drug-registration, pricing and licensing services to EDE in January 2026. Company + facility registration precede product registration for import and trading, via the EDE portal, with GCC-DR harmonised review plus national steps.
CTD (GCC-DR aligned).
Yes — a UAE-licensed agent / importer of record (the 'importer' captured in the UAE registry).
Yes — the UAE runs a reliance-based model leaning on recognized reference authorities (US FDA / EU), with fast-track registration for innovative or lifesaving/critical-care products (as quick as ~25 days for qualifying cases).
GMP compliance / inspection is required under EDE; recognized prior approvals are leveraged under the reliance model.
Orientation intelligence compiled from public regulator and analyst sources as of the dates shown — not legal or regulatory advice. Rules change; confirm specifics (fees, timelines, baskets, eligibility) with the authority before acting. (Authority: EDE — Emirates Drug Establishment (the UAE federal drug authority; took over registration & pricing from MoHAP); as of 2026-06.)