Drug factory · FDA FEI 3002807210

Hovione Pharmascience Limited

154 Estrada Coronel Nicolau de Mesquita, Taipa, Macau

Macau: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 12, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DanicopanMakes the active ingredient Catalent Pharma Solutions, LLC 11014-0739
DoxycyclineMakes the active ingredient Caraco Pharmaceutical Laboratories, Ltd., Slate Run Pharmaceuticals, LLC. 63304-130, 63304-131, 63304-132 +3

FDA inspection history

EndedResultProgramProblems noted
Dec 12, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 20, 2018No problems foundDrug Quality Assurance—
May 20, 2016No problems foundDrug Quality Assurance—
Jan 30, 2013No problems foundDrug Quality Assurance—
Jun 24, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.