Generic 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).
ANDA
documentation mindset
RS
impurity alignment
Stability
ICH conditions
Supply
campaign continuity
Generic development strategy
Generic API work begins from the reference standard impurity map and pharmacopeial or innovator specifications. We propose route selection that avoids patent-claimed pathways while meeting regulatory orthogonality on impurities.
Materials can support exhibit batches, biostudies, and commercial launch. Documentation depth is negotiated per market (US, EU, ROW) and per whether the API is dually sourced.
Indicative regulatory touchpoints
Solenyx supports data packages; filings remain sponsor-owned unless otherwise contracted.
| Document | Purpose | Typical owner |
|---|---|---|
| Drug master file (DMF) | Confidential manufacturing details | Solenyx or sponsor |
| Drug substance specification | Release and stability criteria | Sponsor with our input |
| Comparability protocol | Post-change continuity | Joint |
| Stability summary | Shelf-life support | Solenyx lab data |
Last reviewed: Forward-looking illustrative layout
Example specification elements
Assay
98.0–102.0%
Pharmacopeial or client
RRT impurities
Per innovator map
Unspecified impurities capped
Residual solvents
ICH Q3C
Route-specific
Elemental impurities
ICH Q3D option 1 or 2
Risk-based
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
Launch readiness
RS-level impurity match
Synthesis and purge rationale for each labeled impurity in the dossier.
Validation lots
Process validation batches with PPQ protocol alignment.
Commercial supply
Forecast-driven campaigns with change-control discipline.
Typical package
- GMP API with COA and certificate of origin
- Stability data at ICH long-term and accelerated conditions
- DMF sections or tech package for LOA models
- Residual solvent and elemental impurity reports
Frequently asked questions
Specific APIs are quoted per program under NDA. This page describes capability, not a public catalog of products.
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View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.