years of active operations in the region as of January 23, 2026
approvals from the US Food & Drug Administration as of January 23, 2026
About
The formation of Macleods Pharma USA, Inc. in 2011, marked the commencement of our pharmaceutical business operations in the United States.
As of August 31, 2023, we had 185 ANDAs filed with the USFDA, of which 100 were approved.
2020 marked the culmination of several block capacity expansions of our facilities for APIs and finished dosages, as we continue to unveil a brand-new manufacturing facility for finished dosages, exclusively for the US market.
Medication Guide
| Sr No. | Medication Guide | View |
|---|---|---|
| 12 | Lacosamide Tablets |  |
| 33 | Vernicline Tablets | |
| 4 | Desvenlafaxine Tablets | |
| 28 | Rivaroxaban Tablets | |
| 30 | Tramadol Hydrochloride Extended-Release Tablets | |
| 34 | Dapagliflozin Tablets | |
| 35 | Dapagliflozin and Metformin HCl Extended-Release Tablets | |
| 1 | Aripiprazole Tablets | |
| 3 | Clopidogrel Tablets | |
| 5 | Duloxetine Delayed-Release Capsules | |
| 6 | Emtricitabine and Tenofovir Disoproxil Fumarate tablets | |
| 8 | Escitalopram Tablets | |
| 9 | Eszopiclone Tablets, Coated CIV | |
| 11 | Ibandronate Sodium Tablets | |
| 13 | Levofloxacin Tablets | |
| 17 | Nevirapine Extended-Release Tablets | |
| 18 | Nevirapine Tablets | |
| 20 | Olanzapine Tablets | |
| 19 | Olanzapine Orally Disintegrating Tablets | |
| 21 | Pantoprazole Sodium Delayed-Release Tablets | |
| 23 | Pioglitazone and Metformin Hydrochloride Tablets | |
| 22 | Pioglitazone Tablets | |
| 25 | Quetiapine Extended-Release Tablets | |
| 26 | Quetiapine Tablets | |
| 27 | Risedronate Sodium Tablets | |
| 29 | Tramadol Hydrochloride Acetaminophen Tablets | |
| 31 | Tramadol Hydrochloride Tablets | |
| 32 | Venlafaxine Hydrochloride Extended-Release Capsules | |
| 2 | Celecoxib Capsules | |
| 16 | Montelukast Sodium Tablets | |
| 24 | Propylthiouracil Tablets | |
| 7 | Escitalopram Oral Solution | |
| 14 | Lurasidone Hydrochloride Tablets | |
| 15 | Montelukast Chewable Tablets | |
| 10 | Febuxostat Tablets | |
Contact
Report Product Quality, Adverse/ Side Effects
Any Adverse Event/Side Effect/Medical Inquiry And Product Quality Complaint Related to Macleods Product Originating From USA:
USA Direct Line : 1-855-926-3384 (Time 09:00 AM to 05:00 PM CDT From Monday to Friday)
USA Toll Free : 1-888-943-3210 (This is a voice message service. We will respond to voice mail within 24 hours from Monday to Friday, 9 AM to 5 PM CDT)
US Office: +1609 269 5250 (Time: 09:00 AM to 05:00 PM EST From Monday to Friday)
Email : safety@macleodspharma.com
Report Product Quality, Adverse/ Side Effects 
