APIXORA

GLOSSARY

API Sourcing Glossary

Definitions of terms used in pharmaceutical API sourcing and import — API, RFQ, DMF, KDMF, CEP, GMP, CoA, MOQ, Incoterms and more — and how each is used on APIXORA.

APIActive Pharmaceutical Ingredient
The active substance in a finished medicine that produces its pharmacological effect. Finished dosage forms such as tablets and capsules are made by combining the API with excipients.
On APIXORA: RFQs and products are registered by API type, such as synthetic, peptide, biological, fermentation, steroid and high-potency.
API IntermediatePharmaceutical intermediate
A material produced during API synthesis that becomes the API after further processing steps. Because it is not the final API, its quality requirements and regulatory treatment can differ from those of the API.
On APIXORA: 'API Intermediate' is a separate API type you can select when issuing an RFQ or registering a product.
ExcipientPharmaceutical excipient
An ingredient other than the API added to make the dosage form, such as fillers, binders, disintegrants and coatings. It is not intended to have a therapeutic effect itself.
On APIXORA: Pharmaceutical excipients are handled as one of the API types and can also be selected as a category in the public sourcing request form.
HPAPIHigh Potency Active Pharmaceutical Ingredient
An API that has a strong pharmacological effect at very small doses. It requires contained facilities and separate handling standards to prevent operator exposure.
On APIXORA: HPAPI and oncology API are separate API types shown on RFQs and products.
RFQRequest for Quotation
A document in which a buyer sets out the product, specification, quantity and conditions it needs and asks suppliers for a quote. Suppliers respond with prices and terms that match the RFQ.
On APIXORA: When a buyer issues an RFQ with the API name, API type, CAS number, specification, required documents and deadline, it is delivered to suppliers that have registered the product.
ProposalQuotation
A supplier's response to an RFQ, covering unit price, quantity conditions, delivery time, specification, delivery terms and payment terms.
On APIXORA: Proposals are released to the buyer after operations-team review, and suppliers are shown under aliases such as 'Supplier #1'.
MOQMinimum Order Quantity
The smallest order quantity a supplier accepts at one time. If the required quantity is below the MOQ, the deal may be difficult or the unit price may change.
On APIXORA: Products and proposals show the MOQ, and a proposal can include a price table with up to three MOQ tiers per purpose.
Lead TimeDelivery lead time
The time from order confirmation to shipment or delivery. It depends on stock availability and the production schedule.
On APIXORA: Proposals show the lead time so buyers can compare it with the unit price and MOQ.
IncotermsInternational Commercial Terms
Trade delivery terms published by the International Chamber of Commerce (ICC) that define where freight, insurance and risk pass from seller to buyer. EXW, FOB, CIF, DAP and DDP are typical examples.
On APIXORA: Proposals, POs and PIs select from 11 terms — EXW, FCA, FAS, FOB, CFR, CIF, CPT, CIP, DAP, DPU and DDP — plus 'To Be Discussed' and 'Other'.
Payment TermsT/T · L/C
Conditions that define when and how payment is made. T/T is a bank wire transfer; L/C is a letter of credit in which a bank guarantees payment.
On APIXORA: Payment terms are written into RFQs and proposals for negotiation; the actual payment is made between the parties outside the platform.
POPurchase Order
The document with which a buyer places a formal order for the agreed product, quantity, price and conditions.
On APIXORA: After selecting a proposal, the buyer issues a PO; the supplier can issue a PI only once a PO exists.
PIProforma Invoice
A preliminary invoice issued by the seller before shipment that states the product, amount, payment and shipping terms. It serves as the basis for import preparation and remittance.
On APIXORA: The supplier issues a PI based on the buyer's PO, and once the buyer confirms it the deal moves on to shipping and settlement.
CoACertificate of Analysis
A document certifying that the test results of a specific batch (lot) conform to the specification. It lists the test items, acceptance criteria and results.
On APIXORA: COA appears among the RFQ required documents and the supplier certificates, and can also be exchanged as a messenger attachment.
MSDS / SDS(Material) Safety Data Sheet
A safety document describing a substance's hazards, handling and storage, and first-aid measures. Under the GHS system it is called an SDS.
On APIXORA: It can be uploaded as a PDF or similar file in the document area or the messenger and shared with the counterparty.
GMPGood Manufacturing Practice
Standards that ensure medicines are consistently manufactured and controlled to quality requirements. For APIs, the ICH Q7 guideline serves as the international standard; the term cGMP emphasizes current standards.
On APIXORA: GMP and WHO-GMP are shown as certificates held, and an RFQ can request GMP and certificate documents as required documents.
DMFDrug Master File
A file or system in which detailed technical data on an API — manufacturing method, quality control and stability — is submitted to a regulator. It lets a finished-product application reference the manufacturer's confidential data without disclosing it directly.
On APIXORA: Products and proposals show a DMF status of 'Registered', 'Under Preparation', 'Available for Registration' or 'Not Available'.
US DMFU.S. FDA Drug Master File
A DMF submitted to the U.S. FDA; APIs mostly fall under Type II. The FDA does not approve a DMF on its own but reviews it when assessing an application that references it.
On APIXORA: 'US DMF' can be selected among the certificates held.
KDMFKorea Drug Master File
Korea's DMF system, under which manufacturing and quality data for an API is registered with the Ministry of Food and Drug Safety (MFDS). The substances subject to registration and the required data follow the relevant laws and MFDS notices.
On APIXORA: 'KDMF(MFDS)' can be shown among the certificates held, and APIXORA supports document review, document exchange and coordination of deficiency responses for registration.
CEPCertificate of Suitability to the Monographs of the European Pharmacopoeia
A certificate issued by the EDQM confirming that the quality of an API is suitably controlled by the relevant European Pharmacopoeia (Ph. Eur.) monographs.
On APIXORA: CEP is shown among the certificates held, and buyers check it when comparing proposals.
WCWritten Confirmation
A document in which the regulator of the exporting country confirms that a manufacturing site's GMP is equivalent to EU standards when an API is exported to the EU.
On APIXORA: WC can be shown among the certificates held and is included in the regulatory documents reviewed under KDMF support.
CoPPCertificate of Pharmaceutical Product
A document under the WHO certification scheme in which the exporting country's regulator certifies a medicine's authorization status and GMP compliance.
On APIXORA: CoPP can be shown among the certificates held and is included in the regulatory document review.
PharmacopoeiaKP · USP · EP · JP · ChP · IP · BP
A compendium of medicine quality standards set by a country or region, such as the Korean Pharmacopoeia (KP), United States Pharmacopeia (USP) and European Pharmacopoeia (EP). It defines test items and acceptance criteria.
On APIXORA: The specification of RFQs and products is selected from KP, USP, EP, JP, ChP, IP and BP.
In-house SpecificationManufacturer's own specification
A quality specification set by the manufacturer when no pharmacopoeial monograph exists or additional control is needed. A specification required by the buyer is called a customer specification.
On APIXORA: Specification options include 'In-house Specification', 'Customer Specification' and 'Any Specification Accepted'.
CAS NumberCAS Registry Number
A unique identifier assigned to each chemical substance by CAS, a division of the American Chemical Society. A substance known by several names is identified by a single number.
On APIXORA: When you type an API name, CAS number candidates are suggested from the master catalog, and choosing one fills in the CAS number.
MFDSMinistry of Food and Drug Safety (Korea)
Korea's regulator responsible for medicine approval and review and for API registration (KDMF).
On APIXORA: APIXORA coordinates responses between manufacturer and pharmaceutical company to MFDS deficiency requests on KDMF.
Linked ReviewLinked review of API registration
A review approach in which API registration data is assessed together with the marketing authorization or variation application of the finished product that uses the API. Deficiency requests raised during review must be answered with the manufacturer's data.
On APIXORA: APIXORA coordinates the questions and answers between manufacturer and pharmaceutical company in linked review and MFDS deficiency requests.
Stability DataStability study data
Data showing whether quality is maintained over time under conditions such as temperature and humidity. It is the basis for storage conditions and the retest date or shelf life.
On APIXORA: It is requested and shown through the 'Stability' group of RFQ required documents and the 'Stability Data' certificate item.
Impurity ProfileImpurity profile
Data describing the types and levels of process-related and degradation impurities that may be present in an API. It is a key item in regulatory review and quality evaluation.
On APIXORA: It can be requested in the 'Impurities' group of RFQ required documents.
R&D · PV · CommercialPurchase purpose stages
A classification of purchase purpose: R&D for research and development, PV for process validation batches, and Commercial for commercial production. Required quantities and unit prices differ by stage.
On APIXORA: Buyers specify the requested purpose and quantity in an RFQ, and suppliers can respond with a price table of MOQ tiers per purpose.
SampleEvaluation sample
A small quantity of material received before the main purchase to test and evaluate quality. Test results are compared with the CoA to judge the supplier's suitability.
On APIXORA: Proposals state whether samples are available, and sample requests and evaluation take place after identity disclosure.
CDA / NDAConfidential / Non-Disclosure Agreement
An agreement not to disclose technical or commercial information exchanged during deal evaluation to third parties.
On APIXORA: APIXORA supports confidentiality agreements and document versioning, and confidential documents are shared between the two companies according to mutual agreement and contract.
CDMOContract Development and Manufacturing Organization
A company that performs process development and manufacturing on behalf of a client. It is used when a custom material or a new process is needed.
On APIXORA: There is no separate contract development feature; custom materials are requested in an RFQ with 'Customer Specification'.
Manufacturer · AgentManufacturer and sales agent
A manufacturer produces the material itself; an agent handles sales and supply on behalf of a manufacturer.
On APIXORA: Both manufacturers and agents can join as suppliers, under the same supplier terms and approval process.

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