July 15, 2020

What is the difference between FDF and API products in the pharmaceutical industry

The Standard Group of Companies is a leading supplier of equipment in the pharmaceutical industry.

Key manufactured products of this industry are: -

  • API (Active pharmaceutical ingredient)
  • FDF (Finished dosage form)

On occasion these types are jargon are confused but are universally used daily and form the foundation of all medicinal products.

Key specific parts of the Standard group support these key manufacturing processes: -

S2 Engineering Services

  • Stainless and exotic alloy equipment

Schematic Engineering Industries

  • Containment systems

Standard Glass Lining Technology

  • Glass lined equipment

Differences between API and FDF

API

An API is the active pharmaceutical ingredient which in basic terms is the component of the drug that enacts the intended effect on the consumer’s body.

An example of an API is the drug gliclazide, which is the active ingredient in the drug Diamicron (brand name) and is commonly used to treat Diabetes Type2.

API's require inactive ingredients to enhance taste, improve the ability to swallow, provide a smooth coating and the support the actual drug delivery.

An example of a non-active API is a colouring in a tablet which makes them easier to see and provides familiarity for the consumer.

FDF

An 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 which include solid tablets or capsules, PFS (pre-filled syringes) or a simple liquid solution.

FDFs usually work in conjunction with an API alongside, plus various inactive ingredients.

Therefore, in fully understanding API’s and FDF’s, pharmaceutical formulation is the process in which different chemical substances, including the active drug and non-active ingredients are combined to produce a final medicinal product.

The word formulation is often used in a way that includes dosage form, hence the terminology FDF.

For more information on the S2 Engineering Services division which specialise in the following equipment, typically for the API side of manufacture click here: -

  • Reactors
  • Filters
  • Blenders
  • Dryers
S2 v blenders 2

For more information on the Standard Glass Lining Technology division which specialise in the following equipment click here: -

  • Receivers
  • Heat exchanges
  • Reactors
  • Storage tanks
Standard group glass lined reactors 2

For more information on the Schematic Engineering Industries division which specialise in the following equipment click here: -

  • Barrier Isolators
  • Glove boxes
  • Pass boxes
  • Decontamination systems
Standard group dynamic pass boxes 4

Schematic Engineering Industries predominantly support the FDF side of the pharmaceutical industry.