APIs and advanced intermediates
Drug substance and late-stage intermediates manufactured under scalable, documented processes—bridging custom synthesis efforts to clinical and commercial demand with coherent specifications and supply continuity.
DS & DPI
substance and intermediates
ICH
aligned impurity language
COA
full release panel
HPAPI
contained when required
Intermediates vs drug substance
Advanced intermediates are often the economic heart of an API route: they concentrate precursor value, set impurity ceilings for downstream steps, and define campaign length. We manufacture intermediates with the same analytical rigor as API, with specifications tuned to the next transformation.
Drug substance supply includes salt selection support, residual solvent control per ICH Q3C, and elemental impurity assessment per Q3D where metals appear in the route. Potent APIs move to dedicated HPAPI suites with occupational exposure banding.
Supply grades
Grade choice drives documentation depth and GMP status.
| Feature | Capability | Research | GMP clinical | GMP commercial |
|---|---|---|---|---|
| Full GMP batch records | — | Yes | Yes | |
| Stability program | On request | ICH prototypes | Commitment lots | |
| Regulatory support (DMF) | — | Client-led | Shared or sponsor | |
| HPAPI containment | If needed | If needed | Qualified suites |
Illustrative API release panel
Assay
97.0–103.0%
HPLC or titration
Related substances
Individual / total limits per spec
RRt identification
Residual solvents
ICH Q3C
Class 1 avoided in route design
Water / residue on ignition
Per monograph or spec
Salt form dependent
Polymorph
XRPD or IR
When form is critical
Microbial limits
USP <61>/<62>
Non-sterile oral typical
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
Commercial supply rhythm
Forecast and campaign planning
Rolling forecasts lock raw material procurement and suite scheduling; HPAPI campaigns may require dedicated cleaning verification.
QC release and QP release (EU)
Client-defined release; we provide complete batch documentation for certification.
Lifecycle changes
Post-approval changes managed under change control with comparability protocols.
Frequently asked questions
DMF strategy is project-specific. Some programs are sponsor-owned; others use letter-of-authorization models defined in the contract.
Related
Process Development & Scale-up
Route scouting, reaction optimization, crystallization design, and tech transfer packages that turn a workable lab sequence into a reproducible plant-ready process—without rediscovering impurities at every scale tier.
View detailsGeneric Small-Molecule APIs
Off-patent or soon-to-be off-patent APIs manufactured with documentation aligned to generic filing expectations: impurity profiles, DMF support models, and stability data suitable for ANDA-style submissions (sponsor-led filings).
View detailsHigh-Potency APIs (HPAPI)
Contained synthesis, isolation, and packaging of potent compounds classified by occupational exposure band (OEB). Programs include cytotoxic warheads, hormone modulators, and other APIs where µg/m³ air quality targets drive facility design.
View detailsCustom Synthesis
Multi-step organic synthesis from milligram discovery batches through kilogram pilot quantities. We support heterocycles, chiral centers, organometallics and late-stage functionalization with full analytical packages at each handoff.
View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.