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North Macedonia · APIs

APIs supply to North Macedonia

The APIs division counts 385 products, and each one can be quoted for delivery to North Macedonia. Locally, the main users are in generic pharmaceuticals, automotive catalyst manufacturing and ferronickel & metals. Typical delivery points include Skopje, Štip and Kavadarci. Typical customers for this division are finished dosage formulators, generic dossier developers and veterinary drug manufacturers.

North Macedonia Sample products
385products in this division
24–32 dsea transit from India
4–7 dair freight
10categories

Supplying APIs to North Macedonia

Sea freight reaches Thessaloniki (via road/rail) and Durrës (via road) in about 24–32 days port to port. Urgent or small lots fly to Skopje (SKP) in 4–7 days. Import compliance for this category sits with MALMED (Agency for Medicines and Medical Devices), and we prepare the COA, SDS and commercial documents your broker needs. Common grades for this division are IP, BP, USP and Ph. Eur..

Grades in this division

IPBPUSPPh. Eur.JP (on request)In-house / manufacturer specificationMicronised / particle-size specified

Pharma compliance in North Macedonia

AuthorityMALMED (Agency for Medicines and Medical Devices)
SeaportsThessaloniki (via road/rail), Durrës (via road)
AirportsSkopje (SKP)
Dangerous goodsIMDG by sea, IATA DGR by air

North Macedonia is an EU candidate, and its chemicals legislation largely follows REACH and CLP principles. Notification or registration is handled by the local importer, who also prepares the SDS in Macedonian. APIs and medicinal products are regulated by MALMED, which expects GMP evidence or a manufacturer authorisation. Precursor chemicals require import licences. Almost all sea cargo is discharged at Thessaloniki and moved north by road or rail, and dangerous goods must be declared under IMDG or IATA.

From order to delivery

  1. 1–2 daysQuote and document set agreed

    Price, pack sizes, Incoterm and the paperwork list are confirmed in writing.

  2. 3–7 daysPacking for export

    Stock items are packed in UN-rated drums or cartons. Made-to-order material adds its own lead time.

  3. 1–3 daysExport clearance at Nhava Sheva or Mundra

    Shipping bill filed, dangerous goods declared under IMDG where needed.

  4. 24–32 daysOcean transit to Thessaloniki (via road/rail)

    Port-to-port time depends on the vessel schedule and any transhipment.

  5. 2–5 daysImport clearance

    Your broker clears the goods against local rules. Chemical oversight: Ministry of Environment and Physical Planning / Ministry of Health (chemicals law aligned with REACH/CLP).

Indicative total by sea: 31–49 days

By air: about 8–17 days in total.

Documents for North Macedonia

  • Commercial Invoice
  • Packing List
  • Bill of Lading / Air Waybill
  • Certificate of Origin
  • Certificate of Analysis (COA)
  • Safety Data Sheet (16-section GHS)
  • Macedonian-language SDS (prepared by the importer)
  • GMP certificate / manufacturer authorisation for APIs
  • Import licence for precursor chemicals where applicable
  • Dangerous Goods Declaration (IMDG/IATA) where applicable

A selection we ship to North Macedonia

A rotating sample from the division. Every product in the catalogue can be quoted for this destination.

Full APIs range
Questions

APIs for North Macedonia

Can Zemixal deliver APIs to North Macedonia?
Yes. We ship by sea to Thessaloniki (via road/rail) and Durrës (via road), by air cargo or by express courier depending on quantity and urgency. Every lot carries a COA and a 16-section GHS SDS.
Which documents come with a APIs shipment to North Macedonia?
Commercial invoice, packing list, certificate of analysis and SDS as standard, plus the bill of lading or air waybill and a certificate of origin. Anything specific to MALMED (Agency for Medicines and Medical Devices) is agreed with you at quote stage.
How long does delivery to North Macedonia take?
Allow 24–32 days for ocean transit or 4–7 days by air, plus packing, export clearance and import clearance. The timeline on this page shows each stage.
What information should I include when requesting an API quotation?
State the molecule, required pharmacopoeia and edition, quantity, intended use and destination country. Mention any special needs such as micronised particle size, a specific polymorph or limits on residual solvents. If your regulator needs manufacturer documents, list them too, so we can confirm availability before pricing.
Can you supply small API samples for formulation trials?
Many APIs can be supplied in development quantities for pre-formulation and stability work. The available sample size depends on the manufacturer and on how the molecule is regulated. Share your project stage and the amount you need, and we will advise what can ship as a sample and what requires a full commercial order.

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