An intermediate is a material produced in the process steps of the API and must undergo further molecular change or refining to become the API, and the intermediate can be separated or not separated. An active ingredient is an active ingredient that has been synthesized and has been synthesized for pharmaceutical use. Intermediates can only be used to synthesize the next product, through which the API can be manufactured, while the API can be directly formulated.
Active Pharmaceutical Ingredient (Active Pharmaceutical Ingredient): A substance or mixture of substances intended for use in the manufacture of a pharmaceutical product and, when used in a pharmaceutical product, becomes an active ingredient in a pharmaceutical product. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or can affect the function and structure of the body. APIs are active products that have completed the synthetic pathway, while intermediates are products somewhere in the synthetic pathway. APIs can be formulated directly, while intermediates can only be used to synthesize the next product, and APIs can only be manufactured through intermediates.
From the definition, it can be seen that intermediates are the key products of the previous process of making APIs, which are different from the structure of APIs. In addition, there are detection methods for APIs in the pharmacopoeia, but there are no intermediates. Speaking of certification, the current FDA requires that intermediates must be registered, but COS does not, but there must be a detailed process description of the intermediates in the CTD document. In China, there is no mandatory GMP requirement for intermediates.
Pharmaceutical intermediates do not require a production license like APIs, and the entry barrier is relatively low and the competition is fierce. Therefore, quality, scale and management level are often the foundation of enterprise survival and development, and the increasing pressure on environmental protection has also made many small enterprises gradually withdraw from the competitive stage, and the industry concentration is expected to increase rapidly. It is generally believed that the following three directions will be the key to improving profitability, increasing added value and sustainable growth of related enterprises:
(1) Product diversification and high-end, from the production of extensive low-end intermediates to fine high-end intermediate products;
(2) Take the road of professional outsourcing services, continue to extend in the outsourcing service industry chain, and undertake R&D outsourcing services;
(3) Focus on pharmaceuticals and attack the APIs and preparations downstream of intermediates.