What are pharmaceutical intermediates?
Pharmaceutical intermediates are compounds that form part of an active pharmaceutical ingredient (API). Pharmaceutical intermediates are produced as by-products in the production of APIs. Each reaction in the API production process produces a number of different pharmaceutical intermediates. It can only be turned into an API through further molecular changes or refinements. Intermediates may or may not be isolated. Pharmaceutical intermediates are used in the production of APIs and are also used for R&D purposes by various pharmaceutical and biopharmaceutical companies.
What is an active pharmaceutical ingredient?
Active Pharmaceutical Ingredient (API) refers to the active ingredient contained in a drug. Any substance or mixture of substances intended to be used in the manufacture of a drug , when used in the manufacture of a drug, will become the active ingredient of the drug. Such substances are intended to provide pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.
If you take Tamiflu tablets as an example, oseltamivir 30 mg is actually the API (a powder responsible for the tablet’s ability to treat the flu). But in reality, the tablet contains more than 30 mg of oseltamivir. In addition to oseltamivir, tablets may also contain some colorants, binders, fillers, preservatives, etc., which are collectively referred to as “excipients”. Thus, the combination of API (oseltamivir) and excipients (binders, fillers, colorants, etc.) constitutes any finished drug product (tablets, capsules, syrups, etc.).
What is the difference between active pharmaceutical ingredients and intermediates?
From the perspective of new drug development, APIs are compounds that have undergone sufficient pharmaceutical research and can be safely used in humans for therapeutic diagnosis. Pharmaceutical intermediates are compounds during the synthesis of APIs that may have no therapeutic effect or be toxic. Note that this doesn’t have to be the case, some intermediates in API synthesis are also APIs.
From the perspective of drug management, APIs must be registered with the drug regulatory authorities (US FDA and European EMEA) in accordance with the law, and synthesized in a GMP-compliant factory after obtaining an approval number. Intermediates are just by-products in the API synthesis process and do not require approval numbers. It should be noted that although some compounds are identical to APIs, they are not APIs if they do not have an approval number or are produced in a non-GMP facility.
Traditionally, APIs and intermediates are produced by pharmaceutical companies in their home countries. But in recent years, many companies have opted to move manufacturing overseas to cut costs. As a result, many pharmaceutical companies are located in the US and UK, but most API and intermediate manufacturers are overseas. The largest regions are in Asia, especially India and China. Several studies have shown that the production costs associated with pharmaceutical intermediates, APIs and final pharmaceutical formulations are reduced by approximately 50-60% in emerging Asian markets compared to North America and Europe. This has led to major changes in the way these drugs are regulated, with stricter guidelines and inspections being implemented.
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