Trust that stands up to an audit
Every product we release is backed by validated processes, a fully equipped QC laboratory, and documentation your regulators can verify.
WHO-GMP production, ICH-aligned quality
Our facility operates to WHO Good Manufacturing Practice across dedicated sterile and non-sterile lines, with a beta-lactam suite fully segregated to prevent cross-contamination.
Grade A aseptic filling under isolators Environmental monitoring & validated cleaning Batch records reviewed and released by a qualified person Serialized packaging for full traceability ICH-condition stability program on every product
QC laboratory capabilities
HPLC & UPLC assay and impurity profiling Gas chromatography for residual solvents Dissolution and disintegration testing Sterility and bacterial endotoxin testing Karl Fischer moisture determination FTIR & UV identity confirmation Microbial limit and bioburden testing Stability chambers (ICH conditions)
Certifications & regulatory support
Facility audited to WHO GMP standards for sterile and non-sterile production.
Certified quality management across manufacturing and distribution.
Certified environmental controls for solvent and effluent handling.
EDQM Certificates of Suitability available for selected APIs.
Type-II Drug Master Files filed with the US FDA for key actives.
Validated cold-chain and ambient logistics with data-logged shipments.
Documentation that ships with your order
Complete records mean faster registrations and confident quality assurance on your side.
Certificate of Analysis (per batch) GMP certificate Drug Master File / CEP (where applicable) Stability & specification data Safety data sheet (SDS) Shipment temperature log
Compliance & ordering FAQ
We supply business-to-business only: licensed pharmacies, wholesalers, hospitals and pharmaceutical manufacturers.
No. Prescription-gated products are supplied exclusively to authorized, licensed businesses and never to individual consumers. All applicable import, licensing and prescription requirements of the destination country must be met.
Every batch includes a Certificate of Analysis. Depending on the product we can also provide GMP certificates, Drug Master Files, CEPs, stability data and shipment temperature logs.
Submit a request through our quote form. Our commercial team responds with pricing, lead time, and required import documentation for your market.
We dispatch worldwide through DHL, FedEx, UPS, EMS and TNT, including temperature-controlled and healthcare-dedicated services with full data-logged chain-of-custody.
In-stock finished products typically dispatch within 5–10 business days of order confirmation and document clearance. Made-to-order APIs and large volumes are scheduled against a confirmed production slot.
Have a compliance question we haven’t covered?
Contact our compliance team