What is the Difference Between API and Intermediate .pdf
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What is the Difference Between
API and Intermediate?
What is API?
API (active pharmaceutical ingredient) refers to the active ingredient contained
in a drug. Any substance or mixture of substances intended for use in the
manufacture of a drug (drug), when used in the manufacture of a drug, will
become the active ingredient of the drug product. Such substances are intended
to provide pharmacological activity or other direct effects in the diagnosis, cure,
mitigation, treatment or prevention of a disease, or to affect the structure or
function of the body.
If you consider an example-in a Tamiflu brand tablet, oseltamivir 30 mg is
actually API (a powder responsible for the tablet's ability to treat influenza). But
in fact, the tablet contains more than 30 mg of oseltamivir. In addition
to oseltamivir, the tablet may also contain some colorants, binders, fillers,
preservatives, etc. All these materials are collectively referred to as "excipients".
Therefore, the combination of API (oseltamivir) and excipients (binders, fillers,
colorants, etc.) constitutes any finished medicine (tablets, capsules, syrups,
What is Pharmaceutical Intermediate?
Pharmaceutical intermediates are chemical compounds that form the building
blocks of active pharmaceutical ingredients (APIs). Pharmaceutical
intermediates are produced as by-products during the production of APIs. Each
reaction in the API production process produces a variety of different
pharmaceutical intermediates. It can only be turned into API by further
molecular change or refinement. Intermediates can be separated or not
separated. Pharmaceutical intermediates are used in the production of bulk
drugs and are also used by various pharmaceutical and biopharmaceutical
companies for research and development purposes.
What is the Difference Between API and Intermediate?
From the perspective of new drug development, an API is a compound that can
be safely used in the human body for therapeutic diagnosis after sufficient
pharmaceutical research. The pharmaceutical intermediate is a compound in
the process of synthesizing the API, which may not have a therapeutic effect or
be toxic. Please note that this is not necessarily the case, some intermediates in
the synthesis of APIs are also APIs.
From the perspective of pharmaceutical management, APIs must be registered
with the drug regulatory authority (FDA in the US and EMEA in Europe)
according to law and synthesized in a GMP-compliant plant after obtaining the
approval number. The intermediate is only a byproduct in the process of
synthesizing the API and does not need to obtain an approval number. It should
be noted that although some compounds are the same as APIs, if they have not
obtained the approval number or are not produced in the GMP factory, they are
Traditionally, APIs and intermediates are produced by pharmaceutical
companies in their home countries. But in recent years, many companies have
chosen to shift manufacturing overseas to reduce costs. As a result, many
pharmaceutical companies are located in the United States and the United
Kingdom, but most API and intermediate manufacturers are overseas. The
largest regions are in Asia, especially India and China. Some researches indicate
that compared with North America and Europe, the production costs associated
with pharmaceutical intermediates, APIs, and final drug formulations are about
50-60% lower in emerging Asian markets. This has caused significant changes
to how these drugs are regulated, with more rigorous guidelines and inspections
put into place.
A leading Chinese manufacturer of APIs and intermediates is Huateng Pharma,
which provides API and pharmaceutical intermediates with high quality and
competitive price. Huateng's new GMP plant is now under construction and will
be put into production this year.