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In the pharmaceutical industry, you might hear the terms “FDF” and “API” frequently used in reference to products. Within the industry itself, of course, we understand this type of jargon, but we certainly can see how the general public would feel overwhelmed looking at those kinds of terminology abbreviations. For reference, they mean, respectively, “finished dosage form” and “active pharmaceutical ingredient.”
At Tedor Pharma, we may be leaders in pharmaceutical formulation for our clients, but we also want to be understandable to laypeople and the rest of the public. The world of solid-dose production can indeed be quite technical and involved, but it means nothing if our work is so opaque as to be confusing.
In that case, we will be using this article to discuss the difference between FDF and API and how these two pieces of the pharmaceutical formulation process are interrelated.
WHAT IS AN FDF?
As stated previously, FDF stands for Finished Dosage Form, and it refers to the actual finalized drug product that is meant for consumption. FDFs can take a variety of forms, including solid tablets or capsules, a liquid solution, or another type. FDFs usually contain an API alongside various inactive ingredients.
In this case, then, the next time you see “FDF” in reference to pharmaceuticals, you will know the term simply refers to the physical form of the drug that was produced for sale at any pharmacy where customers shop.
WHAT IS AN API?
We just referenced API, or active pharmaceutical ingredients, but we can get into some more detail here. At an extremely basic level, an API is the component of the drug that enacts the intended effect on the consumer’s body. For instance, the drug acetaminophen is the active ingredient in a whole host of over-the-counter pain-relief medications.
Recombinant Diabetes API contrast with inactive ingredients, those elements of a drug that are necessary for its production but have no effect on the condition the consumer is trying to change. Dye is an example of an inactive ingredient that might be used in a pill to lend it a certain color.
Although inactive ingredients play no role in the drug making you feel better, they can have side effects on the body. Read the possible side effects on the next container of prescription medications you get to see how these ingredients might affect you.
YOUR FIRST CHOICE FOR PHARMACEUTICAL FORMULATION
We hope this article has educated you in a fundamental subject area of pharmaceutical formulation, that of Oncology APIs and FDFs. If you read through the definitions and explanations above, you will see that, although FDFs and APIs are entirely different in concept, they are nearly inseparable when it comes to developing and producing pharmaceuticals.
This subject matter is what we do every day at Tedor Pharma. Our processes run from drug development all the way through commercialization. Particularly in the area of formulation, in which we create viable means of drug delivery from active ingredients, we have the experience and operational strength to see our clients through their challenges. We like to say that we are small enough to give your projects the attention they deserve and experienced enough to get the job done, and it’s true.
Application programming interfaces enable information systems to communicate and transfer data among each other. Depending how it is configured, a Medical Device API can enable a system to send or retrieve data that can update an individual’s record or provide collective data that can be used to create reports. An API also can send information from one system to another.
A healthcare provider organization, for example, can input a patient’s information into a system that works with insurance companies and nearly automatically determine the patient’s coverage for a specific procedure or medication. That is enabled by an API.
APIs have a big part to play in health IT interoperability in the years ahead, especially as the data exchange rules of the 21st Century Cures Act encourage their standardization and proliferation across the healthcare ecosystem. Here, some API experts point the way forward for APIs and describe where they can be of most help.
Medical Devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in-vitro diagnostics (IVD) products, such as reagents, test kits, and blood glucose meters. Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.
The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. Once you have defined the intended use and indications for use of your product, you can determine if the product meets the definition of a medical device.