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Romania · APIs

APIs shipped to Romania

The APIs division counts 385 products, and each one can be quoted for delivery to Romania. Locally, the main users are in generic pharmaceuticals & antibiotics, petroleum refining and chlor-alkali & PVC. Typical delivery points include Bucharest, Iași and Cluj-Napoca. Typical customers for this division are finished dosage formulators, generic dossier developers and veterinary drug manufacturers.

Romania Sample products
385products in this division
24–32 dsea transit from India
4–6 dair freight
10categories

Supplying APIs to Romania

Sea freight reaches Constanța and Galați (Danube) in about 24–32 days port to port. Urgent or small lots fly to Bucharest Henri Coandă (OTP) in 4–6 days. Import compliance for this category sits with ANMDMR (National Agency for Medicines and Medical Devices) / EMA, 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 Romania

AuthorityANMDMR (National Agency for Medicines and Medical Devices) / EMA
SeaportsConstanța, Galați (Danube)
AirportsBucharest Henri Coandă (OTP), Cluj-Napoca (CLJ)
Dangerous goodsIMDG by sea, IATA DGR by air

Romania applies EU REACH and CLP. Substances imported at 1 tonne or more per year need registration by the EU importer or an Only Representative, and SDS and labels must be in Romanian. API imports require an EU written confirmation or equivalent GMP standing and an importer authorised by ANMDMR. Constanța is reached on Asia services via Suez, often with a transhipment in the eastern Mediterranean. Customs needs the importer's EORI number, and dangerous goods follow IMDG or IATA rules.

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 Constanța

    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: ECHA (EU REACH & CLP).

Indicative total by sea: 31–49 days

By air: about 8–16 days in total.

Documents for Romania

  • Commercial Invoice
  • Packing List
  • Bill of Lading / Air Waybill
  • Certificate of Origin
  • Certificate of Analysis (COA)
  • Safety Data Sheet (16-section GHS)
  • REACH registration number or Only Representative declaration (substances ≥1 t/yr)
  • SDS in REACH Annex II format in the local language (supplied to the EU importer)
  • EU Written Confirmation for API imports (Art. 46b Directive 2001/83/EC)
  • EORI number of the EU importer (customs declaration)
  • Dangerous Goods Declaration (IMDG/IATA) where applicable

Categories in APIs

Antibiotic & Antibacterial APIs 60Antiviral, Antifungal & Antiparasitic APIs 39Analgesic & Anti-inflammatory APIs 28CNS & Psychiatric APIs 61Cardiovascular & Antihypertensive APIs 41Antidiabetic, Hormone & Metabolic APIs 47Respiratory & Antiallergic APIs 30Gastrointestinal APIs 25Oncology APIs 12Vitamins, Excipients & Other APIs 42

A selection we ship to Romania

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

Full APIs range
Questions

APIs for Romania

Can Zemixal deliver APIs to Romania?
Yes. We ship by sea to Constanța and Galați (Danube), 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 Romania?
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 ANMDMR (National Agency for Medicines and Medical Devices) / EMA is agreed with you at quote stage.
How long does delivery to Romania take?
Allow 24–32 days for ocean transit or 4–6 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.

Other divisions for Romania

Lab Reagents Solvents (HPLC & GC) Biochemicals Impurity Reference Standards Pharmaceutical Intermediates Inorganics & Metals Specialty Chemicals

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