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 Jarrad Davis
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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 Marvin Jones
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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) isolationrecovery 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 Darius Slay Jr
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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 Matthew
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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
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