Quality & compliance
The documentation arrives before the question does.
We do not manufacture. We qualify the people who do — and we carry the paperwork that proves it, on every consignment.
Manufacturing standards
We source only from certified facilities.
WHO-GMP
World Health Organization GMP
Baseline manufacturing standard for every partner facility we source from.
USFDA
US Food & Drug Administration
Facilities inspected and registered for supply into the United States.
EU-GMP
European GMP
Written confirmation and EU GMP compliance for European supply.
ISO
ISO quality systems
Documented quality management across manufacturing and testing.
Regulatory filings
84 of our 126 listed APIs carry filings.
Filings are listed per product in the portfolio, so you can confirm regulatory fit before you ask for a price.
Check a product →- DMF
- Drug Master File referenced with the receiving regulator
- 83
- ANVISA
- Brazilian health authority registration for LATAM supply
- 73
- EU-GMP
- European GMP compliance on file
- 58
- CEP
- Certificate of Suitability to the European Pharmacopoeia
- 32
Counts reflect products in the current portfolio with that filing recorded.
What ships with the goods
Every consignment, fully papered.
- Certificate of Analysis (batch-specific)
- GMP certificate for the manufacturing site
- Material Safety Data Sheet
- Technical specification and method of analysis
- Stability data, where applicable
- DMF / CEP reference letters, where filed
Need something specific for your regulator — a written confirmation, an elemental impurity statement, a nitrosamine risk assessment? Ask at inquiry stage and we will confirm availability before you commit.