Pharmaceutical Intermediates Supplier
Ninety-five Key Starting Materials and advanced intermediates manufactured to the same QMS we use for APIs. ICH Q11 starting-material justification documents available. Bulk and custom synthesis from gram-scale POC to multi-ton commercial supply.
KSM vs advanced intermediate — what we supply
Under ICH Q11, an API manufacturer must justify their choice of Key Starting Material (KSM) — the point in the synthesis tree below which they don’t need to fully describe upstream chemistry to regulators. We supply both:
- KSMs — molecules positioned for use as the buyer’s declared starting material. We provide impurity profile data, structural elucidation, and a Q11-style justification framework the buyer can adapt to their own dossier.
- Advanced intermediates — molecules closer to the final API, used by buyers who declare their KSM further upstream. We provide quality-by-design (QbD) impurity-track data and full retain samples.
Quality release for intermediates
Intermediates are released against pharmacopoeial-equivalent specifications where one exists, or against a customer-agreed specification where it doesn’t. Every batch ships with:
- Certificate of Analysis (CoA) signed by QC and QA.
- NMR & mass-spec confirmation of structure.
- Impurity profile by HPLC (or GC where appropriate).
- Retain samples held for 2× the buyer’s API stability claim.
- Manufacturing date, batch number, and traceability log for regulatory review.
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Frequently asked questions
Can you supply an intermediate under non-GMP conditions for cost?
Yes — we run a dedicated non-GMP block for tox batches and research-grade intermediates at a lower price point. Document trail is reduced but traceability is preserved.
Do you support ICH Q11 starting-material justification?
Yes. We provide the buyer with a justification framework — synthesis tree, impurity origin analysis, and proposed starting-material designation rationale — that the buyer can adapt to their own Module 3 CTD section.
Talk to a sales engineer
First response within 4 business hours, Pune time (IST). We can also run a teams call inside your working hours — most weekday hours across the US, EU, LATAM and APAC are covered.