Honour Lab is an API manufacturer based in India. It holds 79 active US drug master files and 9 valid CEPs. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 15 November 2019 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hyderabad, India | Not on file |
| Visakhapatnam, India | Not on file |
| Sangareddy, India | 3009996280 |
| Sangareddy, India | 3011766778 |
| Nalgonda, India | 3021257926 |
| Anakapalli District, India | 3010828439 |
| Molecule | Regulators | Docs |
|---|---|---|
| Pirfenidone | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Brivaracetam | SFDA (Saudi Arabia), US FDA | 4 |
| Colchicine | SFDA (Saudi Arabia), US FDA | 4 |
| Fingolimod | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Sitagliptin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Teriflunomide | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Ticagrelor | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Brexpiprazole | SFDA (Saudi Arabia), US FDA | 3 |
| Clobazam | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Dapagliflozin | SFDA (Saudi Arabia), US FDA | 3 |
| Dapagliflozin Propanediol | SFDA (Saudi Arabia) | 3 |
| Empagliflozin | US FDA | 3 |
| Ertugliflozin | US FDA | 3 |
| Fosfomycin | US FDA | 3 |
| Linagliptin | SFDA (Saudi Arabia), US FDA | 3 |
| Macitentan | SFDA (Saudi Arabia), US FDA | 3 |
| Posaconazole | SFDA (Saudi Arabia), US FDA | 3 |
| Tadalafil | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Apixaban | SFDA (Saudi Arabia), US FDA | 2 |
| Avanafil | SFDA (Saudi Arabia), US FDA | 2 |
| Bempedoic Acid | SFDA (Saudi Arabia), US FDA | 2 |
| Diatrizoate | US FDA | 2 |
| Edoxaban | SFDA (Saudi Arabia), US FDA | 2 |
| Sacubitril | US FDA | 2 |
| Sugammadex | SFDA (Saudi Arabia), US FDA | 2 |
| Tofacitinib | SFDA (Saudi Arabia), US FDA | 2 |
| Vildagliptin | SFDA (Saudi Arabia), US FDA | 2 |
| Alogliptin | US FDA | 1 |
| Atogepant | US FDA | 1 |
| Avatrombopag | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 25 | None |
| MINSA (CR) | 4 | None |
| EMA | None | 1 |
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