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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
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, etc.)
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 not APIs.
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
Except for Pharmaceutical Intermediates, lots of
Pesticides Intermediates are widely used in agriculture and production.