Is Macleods Pharmaceuticals Limited FDA approved?

Macleods Pharmaceuticals Limited holds 5 FDA-registered establishments in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Macleods Pharmaceuticals Limited's drugs manufactured?

The FDA register lists Bharuch; Daman; Dhar; District Solan; Valsad. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction.

What drugs does Macleods Pharmaceuticals Limited make?

390 products are listed under Macleods Pharmaceuticals Limited in the openFDA NDC Directory, most often as tablet, film coated; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Macleods Pharmaceuticals Limited

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 5
Active NDC listings: 390
Labeller names: 2
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing5Active ingredient (API) manufacture2Labelling5Finished drug manufacture4Packaging5particle size reduction1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Macleods Pharmaceuticals Limited	Plot No. D-3/ 27 Dahej Road, Sambheti Village, Dahej, Bharuch, Gujarat 392130, India (IND)	Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging	3018972378854247786
Macleods Pharmaceuticals Limited	Plot No 25-27, Survey No 366 Premier Industrial Estate Kachigam, Daman, Daman 396210, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3006363714918608365
Macleods Pharmaceuticals Limited	Plot No M-50 to M-54-A Indore, Special Economic Zone,Phase II, Pithampur., Dhar, Madhya Pradesh 454774, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3018011011854247775
Macleods Pharmaceuticals Limited	Village Theda, Post Office Lodhimajra,Tehsil Baddi, District Solan, Himachal Pradesh 174101, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3007517881676369519
Macleods Pharmaceuticals Limited	Plot No. 2209, GIDC Industrial Estate Sarigam, Umbergeon, Valsad, Gujarat 396155, India (IND)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction	3006607469650376184

Catalogue

Drug listings by form and route

390

390 active NDC listings: 376 human prescription drug, 14 bulk ingredient. By marketing category: ANDA 376, BULK INGREDIENT 14.

Dosage form	NDCs
tablet, film coated	123
tablet	114
capsule	36
tablet, extended release	26
capsule, extended release	16
powder	14
capsule, delayed release	11
ointment	9
tablet, orally disintegrating	8
solution	7
cream	5
tablet, film coated, extended release	5
powder, for suspension	4
kit	3
tablet, coated	3

Route	NDCs
oral	356
topical	17

Labeller name on the listing	NDCs
macleods pharmaceuticals limited	389
macleods pharmaceutical limited	1

Catalogue

Marketed products

390

Showing 150 of 390.

Brand	Generic name	Form / route	NDC
AMLODIPINE and OLMESARTAN medoxomil	AMLODIPINE and OLMESARTAN medoxomil	tablet, film coated, oral	33342-190ANDA
AMLODIPINE and OLMESARTAN medoxomil	AMLODIPINE and OLMESARTAN medoxomil	tablet, film coated, oral	33342-191ANDA
AMLODIPINE and OLMESARTAN medoxomil	AMLODIPINE and OLMESARTAN medoxomil	tablet, film coated, oral	33342-192ANDA
AMLODIPINE and OLMESARTAN medoxomil	AMLODIPINE and OLMESARTAN medoxomil	tablet, film coated, oral	33342-193ANDA
Abacavir and Lamivudine	Abacavir and Lamivudine	tablet, film coated, oral	33342-440ANDA
Acyclovir	Acyclovir	ointment, topical	33342-439ANDA
Apixaban	Apixaban	tablet, film coated, oral	33342-337ANDA
Apixaban	Apixaban	tablet, film coated, oral	33342-338ANDA
Aripiprazole	Aripiprazole	tablet, oral	33342-122ANDA
Aripiprazole	Aripiprazole	tablet, oral	33342-123ANDA
Aripiprazole	Aripiprazole	tablet, oral	33342-124ANDA
Aripiprazole	Aripiprazole	tablet, oral	33342-125ANDA
Aripiprazole	Aripiprazole	tablet, oral	33342-126ANDA
Aripiprazole	Aripiprazole	tablet, oral	33342-127ANDA
-	Atomoxetine Hydrochloride	powder	33342-602BULK INGREDIENT
Atorvastatin calcium	Atorvastatin calcium	tablet, oral	33342-315ANDA
Atorvastatin calcium	Atorvastatin calcium	tablet, oral	33342-316ANDA
Atorvastatin calcium	Atorvastatin calcium	tablet, oral	33342-317ANDA
Atorvastatin calcium	Atorvastatin calcium	tablet, oral	33342-318ANDA
Bupropion Hydrochloride (SR)	Bupropion Hydrochloride	tablet, extended release, oral	33342-526ANDA
Bupropion Hydrochloride (SR)	Bupropion Hydrochloride	tablet, extended release, oral	33342-527ANDA
Bupropion Hydrochloride (SR)	Bupropion Hydrochloride	tablet, extended release, oral	33342-528ANDA
Candesartan	Candesartan	tablet, oral	33342-114ANDA
Candesartan	Candesartan	tablet, oral	33342-115ANDA
Candesartan	Candesartan	tablet, oral	33342-116ANDA
Candesartan	Candesartan	tablet, oral	33342-117ANDA
Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	33342-131ANDA
Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	33342-132ANDA
Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	33342-133ANDA
Carbidopa, Levodopa and Entacapone	Carbidopa, Levodopa and Entacapone	tablet, film coated, oral	33342-491ANDA
Carbidopa, Levodopa and Entacapone	Carbidopa, Levodopa and Entacapone	tablet, film coated, oral	33342-492ANDA
Carbidopa, Levodopa and Entacapone	Carbidopa, Levodopa and Entacapone	tablet, film coated, oral	33342-493ANDA
Carbidopa, Levodopa and Entacapone	Carbidopa, Levodopa and Entacapone	tablet, film coated, oral	33342-494ANDA
Carbidopa, Levodopa and Entacapone	Carbidopa, Levodopa and Entacapone	tablet, film coated, oral	33342-495ANDA
Carbidopa, Levodopa and Entacapone	Carbidopa, Levodopa and Entacapone	tablet, film coated, oral	33342-496ANDA
Cevimeline Hydrochloride	Cevimeline Hydrochloride	capsule, oral	33342-216ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	33342-425ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	33342-426ANDA
Cholestyramine	Cholestyramine	powder, for suspension, oral	33342-293ANDA
Cholestyramine	Cholestyramine	powder, for suspension, oral	33342-319ANDA
Clobetasol Propionate	Clobetasol Propionate	solution, topical	33342-321ANDA
Clobetasol Propionate	Clobetasol Propionate	spray, topical	33342-326ANDA
Clobetasol Propionate ANDA	Clobetasol Propionate	ointment, topical	33342-506ANDA
Clopidogrel	Clopidogrel	tablet, oral	33342-060ANDA
Colchicine	Colchicine	tablet, oral	33342-341ANDA
Colesevelam Hydrochloride	Colesevelam Hydrochloride	tablet, film coated, oral	33342-197ANDA
Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	capsule, extended release, oral	33342-272ANDA
Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	capsule, extended release, oral	33342-273ANDA
-	Cycloserine	powder	33342-600BULK INGREDIENT
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin and Metformin Hydrochloride	tablet, extended release, oral	33342-406ANDA
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin and Metformin Hydrochloride	tablet, extended release, oral	33342-407ANDA
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin and Metformin Hydrochloride	tablet, extended release, oral	33342-408ANDA
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin and Metformin Hydrochloride	tablet, extended release, oral	33342-409ANDA
Dapsone	Dapsone	tablet, oral	33342-534ANDA
Dapsone	Dapsone	tablet, oral	33342-535ANDA
Darifenacin	Darifenacin	tablet, extended release, oral	33342-276ANDA
Darifenacin	Darifenacin	tablet, extended release, oral	33342-277ANDA
Desvenlafaxine Succinate	Desvenlafaxine Succinate	tablet, extended release, oral	33342-388ANDA
Desvenlafaxine Succinate	Desvenlafaxine Succinate	tablet, extended release, oral	33342-389ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	capsule, extended release, oral	33342-521ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	capsule, extended release, oral	33342-522ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	capsule, extended release, oral	33342-523ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	capsule, extended release, oral	33342-524ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	capsule, extended release, oral	33342-525ANDA
Dimethyl Fumarate	Dimethyl Fumarate	capsule, delayed release, oral	33342-349ANDA
Dimethyl Fumarate	Dimethyl Fumarate	capsule, delayed release, oral	33342-350ANDA
Dimethyl Fumarate	Dimethyl Fumarate	kit	33342-351ANDA
Dimethyl Fumarate	Dimethyl Fumarate	kit	33342-579ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, film coated, oral	33342-027ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, film coated, oral	33342-028ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, orally disintegrating, oral	33342-029ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, orally disintegrating, oral	33342-030ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, film coated, oral	33342-061ANDA
Doxycycline Hyclate	Doxycycline Hyclate	capsule, oral	33342-386ANDA
Doxycycline Hyclate	Doxycycline Hyclate	tablet, oral	33342-392ANDA
Duloxetine Hydrochloride	Duloxetine Hydrochloride	capsule, delayed release, oral	33342-160ANDA
Duloxetine Hydrochloride	Duloxetine Hydrochloride	capsule, delayed release, oral	33342-161ANDA
Duloxetine Hydrochloride	Duloxetine Hydrochloride	capsule, delayed release, oral	33342-162ANDA
Efavirenz	Efavirenz	tablet, oral	33342-013ANDA
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	tablet, film coated, oral	33342-138ANDA
Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	tablet, film coated, oral	33342-106ANDA
Entacapone	Entacapone	tablet, oral	33342-260ANDA
Escitalopram Oxalate	Escitalopram Oxalate	tablet, film coated, oral	33342-036ANDA
Escitalopram Oxalate	Escitalopram Oxalate	tablet, film coated, oral	33342-037ANDA
Escitalopram Oxalate	Escitalopram Oxalate	tablet, film coated, oral	33342-038ANDA
Eszopiclone	Eszopiclone	tablet, film coated, oral	33342-299ANDA
Eszopiclone	Eszopiclone	tablet, film coated, oral	33342-300ANDA
Eszopiclone	Eszopiclone	tablet, film coated, oral	33342-301ANDA
Ezetimibe	Ezetimibe	tablet, oral	33342-373ANDA
Famciclovir	Famciclovir	tablet, film coated, oral	33342-024ANDA
Famciclovir	Famciclovir	tablet, film coated, oral	33342-025ANDA
Famciclovir	Famciclovir	tablet, film coated, oral	33342-026ANDA
Febuxostat	Febuxostat tablets 40 mg	film, oral	33342-274ANDA
Febuxostat	Febuxostat tablets 80 mg	film, oral	33342-275ANDA
Fenofibrate	Fenofibrate	tablet, oral	33342-339ANDA
Fenofibrate	Fenofibrate	tablet, oral	33342-340ANDA
Fenofibrate	Fenofibrate	tablet, oral	33342-347ANDA
Fenofibrate	Fenofibrate	tablet, oral	33342-348ANDA
Fenofibric acid	Fenofibric acid	capsule, delayed release, oral	33342-294ANDA
Fenofibric acid	Fenofibric acid	capsule, delayed release, oral	33342-295ANDA
Fluocinonide	Fluocinonide	solution, topical	33342-320ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	33342-374ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	33342-375ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	33342-376ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	33342-377ANDA
IBANDRONATE SODIUM	IBANDRONATE SODIUM	tablet, film coated, oral	33342-150ANDA
Irbesartan	Irbesartan	tablet, oral	33342-047ANDA
Irbesartan	Irbesartan	tablet, oral	33342-048ANDA
Irbesartan	Irbesartan	tablet, oral	33342-049ANDA
Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	tablet, film coated, oral	33342-057ANDA
Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	tablet, film coated, oral	33342-058ANDA
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	tablet, film coated, oral	33342-200ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-393ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-394ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-395ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-396ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-397ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-398ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-399ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-400ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-401ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-402ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-403ANDA
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	tablet, oral	33342-404ANDA
Labetalol Hydrochloride	Labetalol Hydrochloride	tablet, film coated, oral	33342-515ANDA
Labetalol Hydrochloride	Labetalol Hydrochloride	tablet, film coated, oral	33342-516ANDA
Labetalol Hydrochloride	Labetalol Hydrochloride	tablet, film coated, oral	33342-517ANDA
Lacosamide	Lacosamide	tablet, film coated, oral	33342-302ANDA
Lacosamide	Lacosamide	tablet, film coated, oral	33342-303ANDA
Lacosamide	Lacosamide	tablet, film coated, oral	33342-304ANDA
Lacosamide	Lacosamide	tablet, film coated, oral	33342-305ANDA
Lamivudine	Lamivudine	tablet, film coated, oral	33342-001ANDA
Lamivudine	Lamivudine	tablet, film coated, oral	33342-002ANDA
Lamivudine and Zidovudine	Lamivudine and Zidovudine	tablet, oral	33342-003ANDA
Lansoprazole	Lansoprazole	capsule, delayed release, oral	33342-310ANDA
Lansoprazole	Lansoprazole	capsule, delayed release, oral	33342-311ANDA
-	Lansoprazole	powder	33342-601BULK INGREDIENT
Levofloxacin	Levofloxacin	tablet, film coated, oral	33342-531ANDA
Levofloxacin	Levofloxacin	tablet, film coated, oral	33342-532ANDA
Levofloxacin	Levofloxacin	tablet, film coated, oral	33342-533ANDA
-	Levofloxacin hemihydrate	powder	33342-503BULK INGREDIENT
Lidocaine	Lidocaine	ointment, topical	33342-405ANDA
Linezolid	Linezolid	tablet, coated, oral	33342-352ANDA
Lopinavir and Ritonavir	Lopinavir and Ritonavir	tablet, film coated, oral	33342-163ANDA
Lopinavir and Ritonavir	Lopinavir and Ritonavir	tablet, film coated, oral	33342-164ANDA
Losartan potassium	Losartan potassium	tablet, film coated, oral	33342-044ANDA
Losartan potassium	Losartan potassium	tablet, film coated, oral	33342-045ANDA
Losartan potassium	Losartan potassium	tablet, film coated, oral	33342-046ANDA
Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	tablet, film coated, oral	33342-050ANDA
Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	tablet, film coated, oral	33342-051ANDA

Neighbours

Registered in the same town

Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)Bharuch, IND; Daman, IND · 4 sites
Alkem Laboratories LimitedBharuch, IND; Daman, IND · 3 sites
Sun Pharmaceutical Industries LimitedBharuch, IND · 2 sites
Glenmark Pharmaceuticals Inc., USABharuch, IND; Dhar, IND · 2 sites
Felix Pharmaceuticals PVT LimitedDhar, IND · 2 sites
Meghmani LLPBHARUCH, IND; Bharuch, IND · 2 sites
Lupin LimitedDhar, IND
Ipca Laboratories LimitedDhar, IND
Intas Pharmaceuticals LimitedBharuch, IND
Par Health USA, LLCDhar, IND
Rubicon Research Canada LimitedDhar, IND
Torrent Pharma, Inc.Bharuch, IND

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Enquiry

Common questions

Is Macleods Pharmaceuticals Limited FDA approved?: Macleods Pharmaceuticals Limited holds 5 FDA-registered establishments in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Macleods Pharmaceuticals Limited's drugs manufactured?: The FDA register lists Bharuch; Daman; Dhar; District Solan; Valsad. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction.
What drugs does Macleods Pharmaceuticals Limited make?: 390 products are listed under Macleods Pharmaceuticals Limited in the openFDA NDC Directory, most often as tablet, film coated; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.