By the PharmaTradz BD Team. Published October 2026.
FDC stands for fixed-dose combination: a single tablet, capsule, injection or other dosage form that contains two or more active ingredients in fixed amounts. A well-designed FDC can make treatment simpler, as when HIV patients take one tablet a day instead of three, or TB patients take a few four-drug tablets instead of many separate ones, and can improve adherence for long-term conditions such as high blood pressure and diabetes. A poorly justified FDC, on the other hand, can combine drugs that do not belong together, and regulators treat FDCs with particular care for exactly that reason.
Why FDCs exist
The case for a good FDC is practical. Fewer tablets mean patients are more likely to take their treatment as prescribed. Combinations can make it harder to take one drug of a regimen without the other, which matters for resistance in infections such as TB, HIV and malaria. They can simplify supply, storage and dispensing in health programmes. And for chronic diseases, combinations such as an angiotensin receptor blocker with a diuretic, or metformin with a second diabetes medicine, are now standard practice in many countries.
Several FDCs appear on the WHO Model List of Essential Medicines, particularly for HIV, tuberculosis and malaria, which is a useful signal that a given combination is accepted internationally.
Why regulators are cautious
An FDC is more than the sum of its parts. Regulators generally expect the applicant to show that each ingredient contributes to the effect, that the doses suit the patients who will use it, that the ingredients do not interact badly with each other, and that the combination is stable as a single product. Fixed doses also remove a prescriber's flexibility to adjust one drug without the other.
India is the best-known example of a regulatory clean-up. Over the years, a very large number of FDCs were approved by state authorities without central review. After expert-committee reviews, the government banned 328 FDCs in 2018 as irrational, followed by further bans in 2023 and 2024. FDCs are defined as new drugs that need central approval from CDSCO, a rule dating from 2002 and kept in the New Drugs and Clinical Trials Rules, 2019. For buyers, that history means an FDC sold in India is not automatically acceptable, or even legal, somewhere else.
What makes an FDC hard to make well
Combining two or more drugs in one dosage form is a genuine formulation challenge, and it is worth understanding why some manufacturers do it better than others. The ingredients may react with each other, so they sometimes have to be separated, for example in bilayer tablets or coated pellets. Their doses can be very different, which makes it hard to keep a small-dose ingredient evenly distributed through a large tablet. Each ingredient may need different conditions to dissolve, and the combination has to release every one of them in a way that matches the reference products. And stability has to be proven for the combination as a whole, because one ingredient can speed up the breakdown of another.
For a buyer, this means the quality of an FDC depends heavily on the manufacturer's development work. Ask for the dissolution data for each component, the stability data for the finished combination and, where a reference product exists, the bioequivalence study.
FDCs in export trade
Because FDCs are so common in Indian and some other domestic markets, they show up often in export enquiries. A few points save a lot of time.
Check that the combination is registered, or registrable, in the destination country. Many combinations widely sold in South Asia have no equivalent registered in Europe, North America or many African and Latin American markets. If there is no reference product, registration may need far more data than a standard generic.
Ask for the dossier's justification of the combination. A good dossier explains the rationale, cites the evidence and includes stability and, where needed, bioequivalence data for the combination itself.
Name every component and strength exactly in your RFQ: the molecules, the salt forms and the strength of each, plus the release type. Our explainer on hydrochloride versus base explains why the salt form matters, and the same care applies to whether each component is immediate or modified release.
Watch the tender specifications. Public tenders, especially for HIV, TB and malaria, often specify an exact FDC and require WHO prequalification or approval by a stringent regulator. A different combination or strength will not qualify.
Related reading
For the documents an FDC supplier should be able to provide, see our explainers on the CoPP and CTD and ACTD dossiers. Our import guides by region show what each market asks for.
More explainers
Related terms buyers ask about: immediate, extended, delayed and controlled release, batch versus lot numbers, small molecules versus biologics and what an excipient is. For supplier documents, see what a DMF is and how to read a Certificate of Analysis.
How PharmaTradz can help
Tell us the combination, the strengths and the destination market. We check which manufacturers make it, whether it is registered where you want to sell, and what documents are available, before you commit. Our tender supply service covers programme tenders, or you can send us an RFQ.
Frequently Asked Questions(FAQs)
What is the full form of FDC in pharma?
FDC stands for fixed-dose combination: a single dosage form, such as a tablet or capsule, that contains two or more active ingredients in fixed amounts.
What are examples of fixed-dose combinations?
Common examples include combination tablets for tuberculosis and HIV, artemisinin-based combinations for malaria, and combinations for high blood pressure and type 2 diabetes, such as an angiotensin receptor blocker with a diuretic.
Why were FDCs banned in India?
Many FDCs had been approved without central review. After expert-committee reviews found them irrational, India banned 328 FDCs in 2018, with further bans in 2023 and 2024. New FDCs need central approval from CDSCO.
Can an FDC sold in India be exported to any country?
Not automatically. The combination must be registered, or registrable, in the destination country, and many combinations sold in India have no equivalent approved elsewhere.
Do FDCs need bioequivalence studies?
Often, yes. Requirements depend on the regulator and on whether a reference combination product exists, but many regulators expect data for the combination itself, not only for each ingredient.
