Drug factory · FDA FEI 3009843207

Lupin Limited

Unit-1, Plot No. 6A1, 6A2, Sector - 17, Special Economic Zone, Mihan, Nagpur, India

Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2023.

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

4 drug inspections on record since 2015: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Atorvastatin	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-635, 68180-636, 68180-637 +1
Azilsartan	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-236, 70748-237
Celecoxib	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-395, 68180-396, 68180-398 +1
Clobazam	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-157, 68180-158
Clomipramine	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-492, 68180-493, 68180-494
Clonidine	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-606
Dapagliflozin	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-105, 70748-106
Dapagliflozin and Metformin	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-101, 70748-102, 70748-103 +1
Darunavir	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-345, 68180-346
Doxycycline	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-650, 68180-651, 68180-652 +3
Droxidopa	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-987, 68180-988, 68180-989
Emtricitabine and Tenofovir	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-287
Ethacrynic Acid	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-159
Ethambutol	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-280, 68180-281
Fenofibric Acid	Makes it and packages it	Lupin Pharmaceuticals, Inc.	27437-107, 27437-108, 68180-231 +3
Fluoxetine	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-997, 68180-998, 68180-999
Gabapentin	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-348, 68180-349
Glycopyrronium	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-136, 70748-137, 70748-138 +1
Hydrochlorothiazide and Lisinopril	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-518, 68180-519, 68180-520
Levetiracetam	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-112, 68180-113, 68180-114 +1
Lisinopril	Makes it and packages it	BluePoint Laboratories., Lupin Pharmaceuticals, Inc., Quallent Pharmaceuticals Health LLC	68001-332, 68001-333, 68001-334 +18
Lurasidone	Makes it	Lupin Pharmaceuticals, Inc.	68180-670, 68180-671, 68180-672 +2
Memantine	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-246, 68180-247, 68180-248 +1
Metformin	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-338, 68180-339
Metronidazole	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-683, 68180-684
Mirabegron	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-151, 68180-152
Nadolol	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-761, 68180-762, 68180-763
Penicillamine	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-153
Pitavastatin	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-742, 68180-743, 68180-744
Pitolisant	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-386, 70748-387
Sevelamer	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-133, 70748-173
Tadalafil	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-914
Tolvaptan	Makes it and packages it	Lupin Pharmaceuticals, Inc.	70748-238, 70748-239, 70748-240 +4
Tramadol	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-697, 68180-698, 68180-699
Valproic Acid	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-260, 68180-261
Zileuton	Makes it and packages it	Lupin Pharmaceuticals, Inc.	68180-169

FDA inspection history

Ended	Result	Program	Problems noted
Jul 11, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	2
Aug 8, 2019	No problems found	Drug Quality Assurance	—
May 11, 2018	No problems found	Drug Quality Assurance	—
Mar 27, 2015	No problems found	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jul 11, 2023 inspection

Sample identification and other information 21 CFR 211.194(a)(1)
Laboratory records do not include a description of the sample received for testing, the quantity of the sample and the date the sample was received for testing.
Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.

Registered with FDA for: manufacture; pack.