Dasami Lab is an API manufacturer based in India. It holds 64 active US drug master files across a filed portfolio of 27 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 May 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Nalgonda, India | 3012753303 |
| Molecule | Regulators | Docs |
|---|---|---|
| Canagliflozin | US FDA | 4 |
| Dextromethorphan | US FDA | 4 |
| Droxidopa | US FDA | 4 |
| Eslicarbazepine Acetate | US FDA | 4 |
| Oxcarbazepine | US FDA | 4 |
| Aminocaproic Acid | SFDA (Saudi Arabia), US FDA | 3 |
| Carbamazepine | SFDA (Saudi Arabia), US FDA | 3 |
| Chlorpromazine | SFDA (Saudi Arabia), US FDA | 3 |
| Spironolactone | SFDA (Saudi Arabia), US FDA | 3 |
| Triethylenetetramine | SFDA (Saudi Arabia), US FDA | 3 |
| Verapamil | SFDA (Saudi Arabia), US FDA | 3 |
| Febuxostat | US FDA | 2 |
| Fluvoxamine | US FDA | 2 |
| Gabapentin Enacarbil | US FDA | 2 |
| Lumateperone | US FDA | 2 |
| Mavacamten | US FDA | 2 |
| Mesalazine | US FDA | 2 |
| Midodrine | US FDA | 2 |
| Mycophenolic Acid | US FDA | 2 |
| Nimodipine | US FDA | 2 |
| Nitazoxanide | US FDA | 2 |
| Pimavanserin | US FDA | 2 |
| Pitolisant | US FDA | 2 |
| Ranolazine | US FDA | 2 |
| Suvorexant | US FDA | 2 |
| Theophylline | US FDA | 2 |
| Viloxazine | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 2 |
| US FDA | None | 1 |
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