How to Source and Import Active Pharmaceutical Ingredients (APIs) from Overseas

The whole process at a glance

Overseas API sourcing runs in this order: find suppliers → issue an RFQ → compare quotations → review samples and documents → contract and order → ship and clear customs → register the regulatory file. Each step involves different documents and responsible parties, so it pays to write down your requirements from the start.

On APIXORA, this flow is displayed as stages — RFQ issued, matching and delivery, quotation submitted, buyer selection, mutual agreement, identity disclosure and samples, ordering and settlement, and deal completed — so you can track how far a deal has progressed.

Step 1 · Define your requirements

First decide the material name and CAS number, the required specification (pharmacopoeia or in-house), the expected annual volume and the purchase purpose. Research and development (R&D), process validation (PV) and commercial production need different quantities and prices, so requesting them by purpose gives more accurate quotes.

Also decide which documents should come with a proposal. Stating up front the documents needed for registration and quality evaluation — GMP certificates, DMF-related data, stability data, impurity data and analytical data — reduces follow-up requests and waiting time.

• Product name (in English) and CAS number
• Specification: KP, USP, EP, JP, ChP, IP, BP, in-house specification or customer specification
• Purpose and quantity: R&D, PV, Commercial
• Required documents: quality, GMP, DMF, impurities, stability, analytical, supply chain, samples and more
• Preferred payment terms and quotation deadline

Step 2 · Find suppliers

When looking for suppliers, check the manufacturing track record for the product, certificates held (GMP, CEP, WC and so on), DMF registration status and manufacturing country. Whether the manufacturer supplies directly or through an agent is also worth confirming.

On APIXORA's public product list you can search matchable APIs, intermediates and excipients without logging in, and leave a sourcing request for products not on the list. Members issue RFQs and receive proposals from suppliers that have registered the product.

Step 3 · Issue an RFQ

An RFQ (request for quotation) puts the product, specification, quantity, documents and conditions in one document so that suppliers can quote on the same basis. The more specific the conditions, the easier the proposals are to compare.

When you submit an RFQ on APIXORA, it is delivered after an operations-team check to suppliers that have registered the product. If you set a quotation deadline, no quotes are accepted after it, so leave suppliers enough time to prepare their documents.

Step 4 · Compare quotations

Do not judge quotations by unit price alone. Put the MOQ, lead time, specification, certificates, DMF status, Incoterms, payment terms and quotation validity side by side on the same basis. An EXW price in particular may look low but can carry separate freight, insurance and customs costs.

On APIXORA, only proposals that pass operations-team review are shown on the buyer's 'Matching results' screen, and suppliers appear under aliases such as 'Supplier #1' until identity disclosure. If a supplier has submitted a price table with MOQ tiers per purpose, you can compare unit prices by quantity tier as well.

Step 5 · Review samples, CoA and documents

Once you have a leading supplier, obtain a sample, run your own tests and compare the results with the supplier's certificate of analysis (CoA). At the same time, review the documents needed for registration and quality assurance, such as GMP certificates, impurity and stability data, and a manufacturing process overview.

Parties often sign a confidentiality agreement (CDA/NDA) before exchanging technical data. On APIXORA, sample requests and evaluation take place after identity disclosure, and documents uploaded against a deal are shared with the counterparty (PDF, DOC, XLS, JPG, PNG; up to 20 MB per file).

Step 6 · Selection, contract, PO and PI

After selecting a supplier, the deal terms are fixed in a contract and the buyer issues a purchase order (PO). The supplier issues a proforma invoice (PI) based on the PO, stating the amount, payment terms and shipping terms.

On APIXORA, selecting a proposal creates the contract automatically, and the deal is confirmed in this order: buyer issues the PO → supplier issues the PI → buyer confirms the PI. Check the PI's payment terms, Incoterms and quantity against the PO before confirming; contracts, POs and PIs can be printed or saved as PDF from the screen.

Step 7 · Shipping, customs and payment

The split of responsibility for shipping and customs is set by the Incoterms in the contract. Under FOB, for example, risk passes when the goods are loaded on board at the port of shipment; under DDP, the seller bears import clearance and duties. Importing APIs can involve import procedures under Korean law, so confirm with a customs broker and your in-house regulatory affairs team.

On APIXORA, payment, settlement and customs clearance take place between the trading parties outside the platform. The platform keeps the status of the ordering and settlement stage and the transaction documents in one place.

Step 8 · DMF/KDMF registration overview

If a material used in a finished product in Korea is subject to API registration, a KDMF must be registered with the MFDS based on the manufacturer's technical data and reviewed together with the finished product's authorization. Deficiency requests during review need the manufacturer's response, so it is wise to confirm the supplier's willingness to provide data and its DMF status from the supplier-selection stage.

APIXORA supports regulatory document review, document exchange, and coordination of linked review and deficiency responses for KDMF registration. The DMF and KDMF guide explains this in detail.