Active Pharmaceutical
Ingredients

All APIs are sourced from GMP-certified partner plants and supplied with batch COA, and the sites are open to customer audits.

For major products we can support DMF, CEP/COS and other market-specific filings, with change notifications agreed contractually.

Crystal form is verified by XRPD for polymorph-sensitive products, and specifications fix the form together with particle size where relevant.

Per ICH M7 risk assessments with appropriate purge studies and, where required, routine testing of flagged impurities.

ICH long-term and accelerated stability programmes support retest periods, and zone IVb data can be shared for hot-climate markets.

Development samples from 100 g, commercial packs from 1-5 kg up to full production volumes depending on the molecule.

COA, MSDS, GMP declaration or DMF reference, and where applicable BSE/TSE, residual solvent and elemental impurity statements.

Stocked APIs ship in 1-3 weeks; campaign production typically requires 6-12 weeks including QC release.

Yes, from milligram scale for toxicology through to commercial launch quantities under a full quality agreement.

Double polyethylene bags in sealed fibre drums, tamper-evident and palletized, with cold-chain packing where the product requires it.