Drug factory · FDA FEI 3011538548

Laurus Labs Limited

Plot No. 19, 20 & 21, Western Sector APSEZ Gurajapalem Village, Rambilli Mandal, Anakapalli, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 10, 2023.

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

2 drug inspections on record since 2017: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AtazanavirMakes it and tests it Laurus Labs Limited 42385-920, 42385-921, 42385-922
AtorvastatinMakes it and tests it Laurus Labs Limited 42385-940, 42385-941, 42385-942 +1
DarunavirMakes it and tests it Dr. Reddy's Laboratories Inc. 43598-704, 43598-705
Efavirenz and Emtricitabine and TenofovirMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-915
Efavirenz and Lamivudine and TenofovirMakes it and tests it Laurus Labs Limited 42385-928, 42385-929
Emtricitabine and Rilpivirine and TenofovirMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-801
Emtricitabine and TenofovirMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-953
GabapentinMakes it and tests it Laurus Labs Limited 42385-972, 42385-973, 42385-974 +2
HydroxychloroquineMakes it, makes the active ingredient and tests it Laurus Labs Limited, Rising Pharma Holdings, Inc. 42385-971, 16571-112
Lopinavir and RitonavirMakes it and tests it Laurus Labs Limited 42385-933, 42385-934
MacitentanMakes it and tests it Laurus Labs Limited 42385-907
MetforminMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-947, 42385-948, 42385-949 +2
Oseltamivir AcidMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-985, 42385-986, 42385-987
PirfenidoneMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-923, 42385-924, 42385-925 +1
PregabalinMakes it and tests it Rising Pharma Holdings, Inc. 64980-410, 64980-411, 64980-412 +5
RilpivirineMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-999
Sacubitrilat and ValsartanMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-930, 42385-931, 42385-932
TenofovirMakes it and tests it Laurus Labs Limited 42385-901
TicagrelorMakes it and tests it Laurus Labs Limited 42385-993, 42385-994
UrsodiolMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-946
ValsartanMakes it, makes the active ingredient and tests it Laurus Labs Limited 42385-989, 42385-990, 42385-991 +1

FDA inspection history

EndedResultProgramProblems noted
Feb 10, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
May 19, 2017No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; manufacture.