Request
Molecule, grade, pharmacopeia, volume, destination and the documents your file needs.
Draft for R.J. Chemicals review
Quality, in documents you can check.
A supplier is approved on paper before a single kilo moves. This is what we send, when, and what depends on the manufacturing source.
What comes with a quote.
The first two always. The rest when your file needs them and the source can provide them.
CoA
Certificate of analysisResults of the manufacturing lot against the monograph you file with: USP, BP or EP.
SDS
Safety data sheetHazards, handling, storage and transport.
CoO
Certificate of originFor customs clearance and import permits.
SPEC
Specification and test methodThe limits and methods behind the CoA, so your lab can repeat them.
GMP
Evidence of the manufacturing siteGMP certificate or inspection outcome of the source, when available.
DMF · CEP
Regulatory accessWhen the manufacturer holds a Drug Master File with the FDA or a Certificate of Suitability with the EDQM, we arrange the letter of access for your filing, under a confidentiality agreement.
ON REQUEST
StatementsTSE/BSE, residual solvents (ICH Q3C), elemental impurities (ICH Q3D), nitrosamine risk assessment.
How a lot reaches you.
Five steps, the same for one drum or a year of supply.
Quote with paperwork
Price, lead time and Incoterm, with the CoA and SDS attached.
Order and lot
Your purchase order is matched to a manufacturing lot.
Release
The certificate of your lot reaches you before it ships.
Shipment
Certificate of origin, packing list and air waybill or bill of lading, also in your customer portal.
The pharmacopeia you file with.
USP, BP and EP describe the same molecule with different tests and limits. We quote to the monograph in your registration, and we ask for the edition when it matters.
- USP, United States Pharmacopeia
- BP, British Pharmacopoeia
- EP, European Pharmacopoeia (Ph. Eur.)
About nitrosamines.
Since 2020 the FDA has asked drug manufacturers to assess and control nitrosamine impurities; its guidance was revised in September 2024. Sartans such as losartan, and metformin, were among the products recalled between 2018 and 2020. We ask our sources for their risk assessment and share it with your quote on request.
General information, not regulatory advice. Your regulatory team decides what your file needs.
Ask for a document.
Customers download lot documents in the portal. Everyone else can ask the assistant or request a quote with the documents checked.