Designed for patients who take this every day
Binova's formulation programs begin with adherence schedules and long-duration dosing data. Efficacy at week one is table stakes; stable, consistent delivery at year three is the benchmark.
/ In-House Integration
API synthesis to finished dose, one quality system
Active pharmaceutical ingredient synthesis and finished dosage form development are conducted in the same facility under a unified quality management system. No handoff gaps, no documentation splits.
Each formulation candidate is evaluated against chronic-use parameters: dissolution consistency across batches, excipient stability at ambient storage, and patient-reported palatability from real adherence studies.
No compound advances without documented stability data
Accelerated Stability Testing
Long-Term Adherence Modeling
Protocol-Gated Scale-Up
Dosage forms are modeled against 12- and 24-month adherence schedules using real patient diary data. Formulation adjustments target daily-use tolerability, not single-dose pharmacokinetics.
Manufacturing scale-up is gated by a signed protocol review, not a project timeline. If the stability record is incomplete, the batch waits. No exceptions are documented in our quality system.
Compounds are held at ICH-defined stress conditions for a minimum of six months before any scale-up decision. Degradation profiles are logged per batch, not per compound class.
Review our formulation protocols
Licensing evaluators and formulary committees can request full stability dossiers, method validation summaries, and batch-record documentation directly from our R&D team.