In order to clearly understand active pharmaceuticals contract manufacturing an understanding of terminology is of prime importance. The first term to understand is what is meant by "active ingredient". PharmaSynth has the capacity to manufacturer most types of APIs. Visit: http://www.pharmasynth.com.au/

1. API Contract Manufacturing
In order to clearly understand active pharmaceuticals contract manufacturing an understanding of
terminology is of prime importance. The first term to understand is what is meant by "active
ingredient". An active ingredient has been defined as any component or substance that is intended to
furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease, or to effect the structure or any function of the body of man or other animals.
The term includes those components that may undergo chemical change and be present in a modified
form intended to furnish the specified activity or effect. In other words, the active ingredient is the
component responsible for the desired effect and has also been called “bulk active” or “bulk drug
substance.”
An active ingredient is formulated with other components that don't perform the intended chemistry or
biochemistry in the body. These latter components are called "inactive ingredients." Active and
inactive ingredients are mixed together in various dosage forms (such as tablet, capsules or liquids) to
yield a "drug product." So within this drug or pharmaceutical product given to a patient, the active
pharmaceutical ingredient (API) represents the ingredient that is intended to furnish pharmacological
activity in a finished drug product.
APIs include substances manufactured by processes such as (1) chemical synthesis; (2) fermentation;
(3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources; or
(5) any combination of these processes. Within the pharmaceutical industry, the entire process of
making a drug product may be conducted by the owner of the drug, or, alternatively, it is not unusual
that the owner may engage an outside party or parties to complete the entire manufacturing process,
or one or more discrete operations, under contract. These outside parties are called Contract
Manufacturing Organisations (CMOs). One possible strategy for a drug owner is to contract with a
CMO to manufacture APIs.
In general, although some companies are hesitant to outsource because of data security, perceived
performance, or concerns around change management, most drug companies have realized the
return on investment has been worthwhile and that with the right partner, the advantages outweigh the
potential risks. Also, through outsourcing, companies may not only be able to decrease overhead
costs over time, but also gain access to a flexible workforce comprised of highly-specialized experts.
Recently, increased outsourcing to CMOs has been observed for drug owners running the gamut from
biopharma to pharma companies, from small to large firms, and for early to late-stage development
projects.
PharmSynth wants to be your trusted partner in the production of APIs. We have the capacity to
manufacturer most types of APIs. PharmaSynth has a TGA (Australian equivalent of the FDA) licence
for the manufacture of human therapeutic APIs from both biological and synthetic sources. We are
cost competitive, and have the resources and expertise to handle all stages of API manufacturing from
pre-clinical, through phases 1, 2 & 3 of clinical development, and into the marketplace.

2. Contact Us
Email: enquiries@pharmasynth.com.au
Website: http://www.pharmasynth.com.au/