Suppliers / Hikma Pharmaceuticals

Hikma Pharmaceuticals

Jordan 4 duplicate records merged Updated 9 July 2026

Hikma Pharmaceuticals is an API and finished-dose manufacturer based in Jordan. It holds one valid CEP across a filed portfolio of 8 molecules. Its filings concentrate with DPM (TN), SFDA (Saudi Arabia) and ANPP (DZ).

0
active US DMFs
1
valid CEPs
4
registered plants
108
filings across 3 regulators

Registered plants

Site FDA FEI
Amman, United Arab Emirates Not on file
Amman, United Arab Emirates Not on file
Amman, Jordan Not on file
Amman, Jordan Not on file

What they file, and where

Molecule Regulators Docs
Zoledronic Acid EDQM, SFDA (Saudi Arabia) 2
Dasatinib SFDA (Saudi Arabia) 1
Erlotinib SFDA (Saudi Arabia) 1
Glycopyrronium SFDA (Saudi Arabia) 1
Ibrutinib SFDA (Saudi Arabia) 1
Neratinib SFDA (Saudi Arabia) 1
Ruxolitinib SFDA (Saudi Arabia) 1
Sunitinib L-Malate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Erlotinib finished dose Ibrutinib finished dose Isavuconazonium finished dose Isoflurane finished dose Ruxolitinib finished dose Zoledronic Acid finished dose Dasatinib API Glycopyrronium API

Filings and GMP by regulator

Regulator Filings GMP certificates
DPM (TN) 68 None
SFDA (Saudi Arabia) 35 None
ANPP (DZ) 5 None

Questions about Hikma Pharmaceuticals

Does Hikma Pharmaceuticals hold a US DMF or a CEP?
Hikma Pharmaceuticals holds 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Hikma Pharmaceuticals manufacture?
4 registered sites are on record, in United Arab Emirates and Jordan (Amman among others). Every site is listed on this page with the register it came from.
What does Hikma Pharmaceuticals make?
8 molecules are on record against Hikma Pharmaceuticals, including Zoledronic Acid, Dasatinib, Erlotinib and Glycopyrronium. Each links through to that molecule's full manufacturer list.
Where does Hikma Pharmaceuticals file?
Filings are on record with DPM (TN), SFDA (Saudi Arabia) and ANPP (DZ), 108 in total.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability