| Regulatory status |
DPI |
APIs |
| Regulatory regard |
Similar to solvates |
Similar to salts of the same API |
| Similarity with parent API |
Yes |
No (if their safety and efficacy are proved different) |
| Coformers |
Neutral guest compound (excipient) |
Non-active components/reagents (excipient) |
| Chemical interactions |
Nonionic |
Nonionic |
| Manufacturing sites |
API manufacturing sites |
API manufacturing sites |
| US-Drug master files (DMF)/EMA-active substance master file (ASMF) registration |
Not feasible being DPI |
Can be filed |
| Applicable good manufacturing practice (GMP) regulations/guide |
cGMP for drug product |
Part II of EU GMP guide (active substances) and ICH Q7 and in rare cases, part I of EU GMP guide (finished drug product) |
