By the PharmaTradz BD Team. Published October 2026.
Pharmaceutical trade runs on abbreviations. A single enquiry can mention an API with a CEP, a CoA and a CoPP, made at a WHO-GMP site, for an LVP to be registered through a CTD dossier. For anyone new to the industry, or working across markets where the same letters mean different things, that alphabet soup gets in the way of a clear conversation. This page explains the abbreviations buyers, importers and manufacturers meet most often, in plain language, grouped by where you are likely to see them. Where we have a full explainer, the term links to it.
Ingredients, products and dosage forms
| Abbreviation | Full form | What it means |
|---|---|---|
| API | Active Pharmaceutical Ingredient | The substance that gives a medicine its effect. See what an API is. |
| HPAPI | Highly Potent API | An API active at very low doses, such as many cancer drugs, which needs contained manufacturing. |
| KSM | Key Starting Material | The chemical building block from which the registered API process begins. |
| FDF / FPP | Finished Dosage Form / Finished Pharmaceutical Product | The finished medicine: tablets, capsules, injections and so on. See drug substance vs drug product. |
| FDC | Fixed-Dose Combination | Two or more active ingredients in one dosage form. See our FDC explainer. |
| IR / ER / DR / CR | Immediate / Extended / Delayed / Controlled Release | How quickly a dosage form releases its drug. See release types explained. |
| ODT | Orally Disintegrating Tablet | A tablet that dissolves on the tongue without water. |
| PFS | Pre-Filled Syringe | A syringe supplied already filled with a single dose of an injectable medicine, common for biologics, vaccines and heparins. |
| LVP / SVP | Large Volume Parenteral / Small Volume Parenteral | Injectable products by container size. Large-volume products (generally over 100 mL) include infusion bags of saline or dextrose; small-volume products include vials and ampoules. |
| ADC | Antibody-Drug Conjugate | An antibody linked to a potent small-molecule drug, used mainly in cancer. See small molecule vs biologic. |
Regulation, dossiers and approvals
| Abbreviation | Full form | What it means |
|---|---|---|
| MA / MAH | Marketing Authorisation / Marketing Authorisation Holder | The licence to sell a medicine in a country, and the company that holds it. |
| NDA / ANDA | New Drug Application / Abbreviated New Drug Application | The US applications for a new medicine and for a generic. |
| RLD | Reference Listed Drug | The approved US product a generic is compared with. |
| BA / BE | Bioavailability / Bioequivalence | Studies showing how much drug reaches the bloodstream, and that a generic performs like the reference product. |
| BCS | Biopharmaceutics Classification System | A system that groups drugs by solubility and permeability; for some, regulators accept laboratory data instead of a BE study. |
| CTD / ACTD | Common Technical Document / ASEAN Common Technical Dossier | The standard dossier formats for registration. See CTD vs ACTD. |
| CMC | Chemistry, Manufacturing and Controls | The quality part of a dossier: how the API and product are made, controlled and tested. |
| DMF | Drug Master File | A confidential file on how an API or material is made. See what a DMF is. |
| LoA | Letter of Authorization (or Access) | Permission from a DMF holder for a customer to reference its file. |
| ASMF | Active Substance Master File | The European equivalent of a DMF, with open and restricted parts. |
| CEP | Certificate of Suitability (to the monographs of the European Pharmacopoeia) | An EDQM certificate used in Europe and many other markets. See CEP vs DMF vs ASMF. |
| SmPC | Summary of Product Characteristics | The approved prescribing information for a medicine in the EU and many other markets. |
| EUA | Emergency Use Authorization | A US mechanism allowing temporary use of unapproved products in an emergency. |
| FDA / EMA / CDSCO | US Food and Drug Administration / European Medicines Agency / Central Drugs Standard Control Organisation | The regulators of the US, the EU and India. Our directory of regulators lists the rest. |
| EDQM | European Directorate for the Quality of Medicines & HealthCare | The body that publishes the European Pharmacopoeia and issues CEPs. |
| ICH | International Council for Harmonisation | The body that writes the shared technical guidelines (Q, S, E and M series) used by major regulators. |
| IP / BP / USP / Ph. Eur. / JP | Indian, British, United States, European and Japanese Pharmacopoeias | The official standards an API or product is tested against. |
Quality, GMP and documents
| Abbreviation | Full form | What it means |
|---|---|---|
| GMP / cGMP | (Current) Good Manufacturing Practice | The rules that make sure medicines are consistently made to quality. See GMP vs cGMP. |
| WHO-GMP | World Health Organization Good Manufacturing Practice | A GMP certificate issued by a national regulator against WHO's standard. See our WHO-GMP explainer. |
| WHO PQ | WHO Prequalification | WHO's own assessment and listing of specific products, used by UN and global health buyers. |
| PIC/S | Pharmaceutical Inspection Co-operation Scheme | A network of GMP inspectorates sharing a common GMP guide. |
| GDP / GLP / GCP | Good Distribution / Laboratory / Clinical Practice | The matching quality standards for storage and transport, non-clinical labs and clinical trials. |
| QA / QC / QP | Quality Assurance / Quality Control / Qualified Person | The quality system, the testing laboratory, and (in the EU) the person who certifies each batch for release. |
| CoA / CoC | Certificate of Analysis / Certificate of Conformance | A batch's test results, or a statement of compliance without them. See how to read a CoA. |
| CoPP | Certificate of a Pharmaceutical Product | The WHO-format certificate of a product's status in the exporting country. See our CoPP explainer. |
| FSC | Free Sale Certificate | Confirms a product may be freely sold in the exporting country; used more for supplements, cosmetics and devices. |
| MSDS / SDS | (Material) Safety Data Sheet | A document describing a substance's hazards, safe handling, storage and emergency measures. The current globally harmonised format, the SDS, has 16 sections. |
| TDS | Technical Data Sheet | A supplier's summary of a material's specifications and properties, typically for excipients and packaging; not a substitute for a CoA. |
| OOS / CAPA | Out of Specification / Corrective and Preventive Action | A test result outside its limit, and the system for investigating and preventing problems. |
| HPLC | High-Performance Liquid Chromatography | The most common laboratory technique for measuring assay and impurities. |
| CAS No. | Chemical Abstracts Service registry number | A unique number identifying a chemical substance, useful for avoiding name confusion. |
Outsourcing and trade
| Abbreviation | Full form | What it means |
|---|---|---|
| CRO / CMO / CDMO / CRDMO | Contract Research / Manufacturing / Development and Manufacturing / Research, Development and Manufacturing Organisation | Outsourcing partners for studies, manufacturing or both. See CRO vs CDMO vs CMO. |
| OEM / ODM | Original Equipment Manufacturer / Original Design Manufacturer | Terms borrowed from other industries for making products under another company's brand, common in nutraceuticals. |
| RFQ | Request for Quotation | A buyer's request for prices and terms. See how to write an RFQ. |
| MOQ | Minimum Order Quantity | The smallest order a manufacturer will accept, often set by batch size. |
| LC | Letter of Credit | A bank guarantee of payment, common for first orders in international trade. |
| FOB / CIF / CIP / DAP | Incoterms | International rules setting who pays freight and insurance and where risk passes from seller to buyer. |
| HS code | Harmonized System code | The customs classification of a product; most finished medicines fall under chapter 30. |
Using this page
Abbreviations can mean different things in different contexts. CMO is a manufacturer in outsourcing but a Chief Medical Officer in a company's leadership team, and "DMF" is often used loosely for any API technical file. When a term matters to a contract, a dossier or a tender, write it out in full the first time. For translations of the most common terms into Spanish, Portuguese, French, Arabic and Russian, see our six-language pharma trade glossary.
How PharmaTradz can help
Whatever acronyms your next enquiry involves, tell us the product, the market and the documents you need, and we will match you with manufacturers who can supply them. Send us an RFQ to get started.
Frequently Asked Questions(FAQs)
What is the full form of PFS in pharma?
PFS stands for pre-filled syringe: a syringe supplied already filled with a single dose of an injectable medicine, widely used for biologics, vaccines and heparins.
What is the full form of MSDS?
MSDS stands for Material Safety Data Sheet. The current globally harmonised version is called an SDS (Safety Data Sheet) and has 16 standard sections on hazards, handling, storage and emergency measures.
What is the full form of LVP and SVP?
LVP stands for large volume parenteral and SVP for small volume parenteral. Large-volume injections are generally over 100 mL, such as infusion bags; small-volume products include vials and ampoules.
What is the full form of CMC in pharma?
CMC stands for Chemistry, Manufacturing and Controls: the quality part of a registration dossier describing how the API and product are made, controlled and tested.
What is the full form of TDS in pharma?
TDS stands for Technical Data Sheet: a supplier's summary of a material's specifications and properties. It does not replace the batch Certificate of Analysis.
What is the difference between NDA and ANDA?
In the US, an NDA (New Drug Application) is used for a new medicine, while an ANDA (Abbreviated New Drug Application) is used for a generic that relies on the reference product's safety and efficacy data.
