Hikma Pharmaceuticals USA INC.
Drug manufacturer · Columbus, OH
Hikma Pharmaceuticals USA INC., based in Columbus, OH, has 3 FDA inspections and 1 recall on file.
FDA record
Recent FDA actions
Financials
No SEC filings under this name. The company is private, listed abroad, or files under a parent.
Fundraising
No SEC Form D filings under this name. A private round is only public when the company files one.
On the market · 40 products
- LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride · ANDA 080407 · prescription
- AZATHIOPRINE SODIUM azathioprine sodium · ANDA 074419 · prescription
- CEFAZOLIN SODIUM cefazolin sodium · ANDA 065143 · prescription
- VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride · NDA 210274 · prescription
- AMPICILLIN AND SULBACTAM ampicillin sodium, sulbactam sodium · ANDA 065406 · prescription
- GALANTAMINE HYDROBROMIDE galantamine hydrobromide · ANDA 078185 · prescription
- ACARBOSE acarbose · ANDA 078470 · prescription
- LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin · ANDA 091375 · prescription
- SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride · ANDA 218797 · prescription
- REGADENOSON regadenoson · ANDA 215827 · prescription
- LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride · ANDA 088803 · prescription
- VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride · ANDA 206616 · prescription
- PREDNISONE prednisone · ANDA 080352 · prescription
- POLYMYXIN B SULFATE polymyxin b sulfate · ANDA 202766 · prescription
- XYREM sodium oxybate · NDA 021196 · prescription
- NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride · NDA 022276 · prescription
- NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride · NDA 022276 · prescription
- LIDOCAINE VISCOUS lidocaine hydrochloride · ANDA 088802 · prescription
- NALOXONE HYDROCHLORIDE naloxone hydrochloride · ANDA 212300 · prescription
- AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin, clavulanate potassium · ANDA 065373 · prescription
- PREDNISONE INTENSOL prednisone · ANDA 088810 · prescription
- DIHYDROERGOTAMINE MESYLATE dihydroergotamine mesylate · ANDA 206621 · prescription
- DIGOXIN digoxin · ANDA 077002 · prescription
- REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride · ANDA 210594 · prescription
- METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate · ANDA 203125 · prescription
- DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride · NDA 050731 · prescription
- ACETAZOLAMIDE SODIUM acetazolamide sodium · ANDA 040089 · prescription
- RAMIPRIL ramipril · ANDA 077900 · prescription
- HEPARIN SODIUM heparin sodium · NDA 017037 · prescription
- BORTEZOMIB bortezomib · ANDA 215011 · prescription
- NUCYNTA tapentadol hydrochloride · NDA 022304 · prescription
- QUETIAPINE FUMARATE quetiapine fumarate · ANDA 090749 · prescription
- SODIUM TETRADECYL SULFATE sodium tetradecyl sulfate · ANDA 209937 · prescription
- FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole · ANDA 076736 · prescription
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE sodium ferric gluconate complex · ANDA 078215 · prescription
- PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride · ANDA 083312 · prescription
- CISPLATIN cisplatin · ANDA 075036 · prescription
- CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride · ANDA 083329 · prescription
- ROCURONIUM BROMIDE rocuronium bromide · ANDA 204679 · prescription
- DAPTOMYCIN daptomycin · NDA 209949 · prescription
Questions about Hikma Pharmaceuticals USA INC
No warning letter naming Hikma Pharmaceuticals USA INC is on file. FDA has published 3 inspection classifications and 1 recall naming it.
FDA has posted 3 inspection classifications naming Hikma Pharmaceuticals USA INC (2 NAI, 1 VAI). The latest inspection ended on 2026-07-13 and was classified VAI (voluntary action indicated). FDA posts a classification after its review, often months after the inspection ended.
Yes. FDA's enforcement reports list 1 recall by Hikma Pharmaceuticals USA INC; the latest, reported on 2026-09-02, is a Class II recall.
Hikma Pharmaceuticals USA INC is based in Columbus, OH. The address is the one on its FDA records, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Hikma Pharmaceuticals USA INC; every record links to the source, and nothing here is advice.
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Products come from FDA's drug application database and, for vaccines, cell and gene therapies and blood products, FDA's Purple Book of licensed biologics; checked 2026-10-23.
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