Documented batch release. Every lot. No exceptions.
Binova manufactures finished dosage forms for chronic-disease schedules under full GMP compliance — with release criteria documented for every batch before it leaves the facility.
Credentials earned through documented compliance
FDA-registered facility. 21 CFR Part 211 compliant. Every production run carries a certificate of analysis and full lot traceability from raw material receipt to shipment release.
100% Lot Documentation
Certificate of analysis issued per batch. No lot ships without passing release criteria.
Shared Quality Agreements
Contract partners receive full documentation access and a co-signed quality agreement covering deviation handling and change control.
No gaps in chronic medication supply
Our supply-chain controls are built around chronic medication schedules — forward-planned production runs, safety-stock protocols, and verified secondary sourcing for critical raw materials.
Procurement partners receive advance lot scheduling, deviation notifications within 24 hours, and direct access to the quality release team — no intermediaries between your formulary and our documentation.
Evaluate us against your supply requirements
Share your formulary specifications and volume requirements. We return a manufacturing proposal with documented capacity, lot scheduling, and quality agreement terms — not a sales deck.