Our facility standard and regulatory filings, at a glance.
Good Manufacturing Practice certification recognised by the World Health Organization, covering our full production facility.
Quality management system certification supporting consistent process control and documentation.
US Drug Master File filings supporting regulatory submissions for the United States market.
European Drug Master File documentation supporting submissions across EU member states.
Drug Master File filing structured for Health Canada regulatory requirements.
Korean Drug Master File documentation for supply into the South Korean market.
Japanese Drug Master File filing supporting formulation partners in Japan.
Certificate of Suitability to the European Pharmacopoeia monograph.
Certificate of a Pharmaceutical Product, issued in line with the WHO certification scheme.
Every shipment can carry the following documentation package, prepared and cross-checked before dispatch.
The same verification path runs behind every order, regulated market or otherwise.
Product specification and applicable pharmacopoeia standard agreed with your quality team.
Production run under WHO-GMP conditions with in-process quality checkpoints.
Final assay, impurity and micro testing before the batch is cleared for release.
Certificate of Analysis generated and cross-verified against the batch record.
Customs and export paperwork prepared alongside the shipment for smooth clearance.
A quick reference for which filing typically applies to your target market.
| Region | Applicable Standard | Filing / Certificate |
|---|---|---|
| United States | USP | USDMF |
| European Union | EP | EDMF / COS |
| Canada | USP / EP | Canadian DMF |
| South Korea | KP | KDMF |
| Japan | JP | JDMF |
| WHO-Prequalified Markets | WHO Guidelines | COPP |
Yes — facility certifications such as WHO-GMP and ISO 9000:2008 can be shared ahead of any order for your vendor qualification process.
We support remote and on-site vendor qualification audits for formulation partners evaluating us as a raw material supplier.
A Certificate of Analysis is issued per manufactured batch, so a shipment covering multiple batches will include a COA for each one.
Tell us the market you're supplying and we'll confirm which filings and certificates apply to your order.
