Macleods Pharmaceuticals is an API and finished-dose manufacturer based in India. It holds 129 active US drug master files and 104 valid CEPs. Its filings concentrate with SAHPRA (ZA), US FDA and DAV (Vietnam). Its GMP standing is certified by MHRA (UK), NCELS (KZ) and CDSCO (India), among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 23 August 2024 as VAI. Customs aggregates show $37.4M of exports covering 1,024 molecules to 85 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Kachigam, United Arab Emirates | Not on file |
| Solan, United Arab Emirates | Not on file |
| Himachal Pradesh, United Arab Emirates | Not on file |
| BILLINGHAM, United Kingdom | Not on file |
| DISTRICT DHAR, India | Not on file |
| Mumbai, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Sitagliptin | EDQM, SFDA (Saudi Arabia), US FDA | 8 |
| Valsartan | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Aripiprazole | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Celecoxib | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Entacapone | EDQM, US FDA | 5 |
| Vardenafil | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Clopidogrel | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Duloxetine | EDQM, US FDA | 4 |
| Irbesartan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Levofloxacin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Metformin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Montelukast | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Nitrofurantoin | EDQM, US FDA | 4 |
| Propylthiouracil | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Rosuvastatin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Tadalafil | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Tamsulosin | EDQM, US FDA | 4 |
| Atomoxetine | EDQM, US FDA | 3 |
| Candesartan Cilexetil | EDQM, US FDA | 3 |
| Carbimazole | EDQM, SFDA (Saudi Arabia) | 3 |
| Hydralazine | EDQM, US FDA | 3 |
| Hydrochlorothiazide | EDQM, US FDA | 3 |
| Indomethacin | EDQM, US FDA | 3 |
| Lacosamide | EDQM, US FDA | 3 |
| Levothyroxine | EDQM, US FDA | 3 |
| Memantine | SFDA (Saudi Arabia), US FDA | 3 |
| Moxifloxacin | EDQM, US FDA | 3 |
| Nebivolol | EDQM, US FDA | 3 |
| Olanzapine | EDQM, US FDA | 3 |
| Olmesartan Medoxomil | EDQM, SFDA (Saudi Arabia) | 3 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| SAHPRA (ZA) | 389 | None |
| US FDA | 251 | 3 |
| DAV (Vietnam) | 142 | None |
| TMDA (TZ) | 99 | 1 |
| EMA | 70 | 5 |
| NMRC (NA) | 62 | None |
| MHRA (UK) | None | 6 |
| NCELS (KZ) | None | 6 |
| CDSCO (India) | None | 6 |
| NAFDAC (NG) | None | 2 |
| UZPHARM (UZ) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| MFDS (Korea) | None | 2 |
| FDA (GH) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $107.3M | 107 |
| 2025 | Not reported | $37.4M | 85 |
| 2024 | Not reported | $5.3M | 26 |
| 2023 | Not reported | $4.6M | 18 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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