Drug factory · FDA FEI 3006896204

Medley Pharmaceuticals Limited

PLOT NO. 18 AND 19, ZARI CAUSEWAY ROAD, KACHIGAM, Daman, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, May 19, 2023.

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

3 drug inspections on record since 2016: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
LacosamideMakes it Kanchan Healthcare Inc, Leading Pharma, LLC, Marlex Pharmaceuticals, Inc. 85742-008, 85742-009, 85742-010 +7
NystatinMakes it Leading Pharma, LLC 69315-504
OxcarbazepineMakes it Kanchan Healthcare Inc 85742-007
VareniclineMakes it Kanchan Healthcare Inc, Leading Pharma, LLC 85742-015, 85742-016, 85742-017 +3

FDA inspection history

EndedResultProgramProblems noted
May 19, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 14, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 19, 2016Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: manufacture.