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What is an API in Pharma (Active Pharmaceutical Intermediate)?

API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine. An active pharmaceutical ingredient (API) is a substance, or a mixture of ingredients, combined in the manufacture of a pharmaceutical or drug. Active pharmaceutical ingredients directly impact disease. Their pharmacological activity plays a direct role in the diagnosis, cure, mitigation, treatment, or prevention of disease. Active pharmaceutical ingredients affect the structure and function of the human body.

 

Active pharmaceutical ingredients are:

•Biochemically created

•Extracted from a plant or animal

•Fermented in a sterile environment

•Non-sterile inorganic mineral

•Sterile intermediate

•Synthesized chemically

•Laboratory created

•Purified plant or animal material

 

There are different kinds of APIs applied for different applications such as heart and celebral vessels API, Anti-neoplastic drugs API, antibiotic drugs API and so on. Mosinter, as one of the leading chemical manufacturer, provides all kinds of quality pharmaceutical intermediates.

 

active pharmaceutical intermediate


Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs.The largest are located in Asia, particularly in India and China.

 

Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. Each brand might use different test methods, that can result in different potencies.

 

A leading manufacturer of APIs is TEVA Pharmaceuticals. With over 300 API products, they have the industry's largest portfolio. Another leading manufacturer is Dr. Reddy's, with more than 60 APIs in use today. Other industry giants are Pfizer, Novartis, Sanofi, Boehringer Ingelheim, and Bristol-Meyers Squibb. Each of these companies specializes in different  APIs, with some offering generic products as well.


production workshop2

 

First of all, as an API manufacturer we think of how to make a chemical compound which becomes an API in the laboratory. We also have to consider the degree of concentration and which temperature allows a high quality of API to be manufactured efficiently. In order to find answers to these questions, our staff in the development department set about conducting a series of experiments. Once they have decided how to make the compound, our staff in the production department manufacture a high quantity of APIs using the large reactors in our plant. Our quality control staff then conducts analyses in the testing laboratory to examine whether the API manufactured is ultrapure. After testing, our quality assurance staff confirms that everything has been performed correctly in accordance with GMP from manufacturing of API to quality testing. As you can see, a considerable number of staff is involved in the production phase until an API is finally manufactured.

 

Mosinter is a professional chemical manufacturer in China offering a wide range of quality chemical raw materials. To find a high-quality supplier of API in China, please contact us via sales@mosinterchem.com.


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MOSINTER GROUP was established in 2004. The main office is located in Ningbo, China. The production are located in Zhejiang Province, Jiangsu Province and Shandong Province in China. Specializing in the production and marketing of chemical products, MOSINTER GROUP has excellent production equipment and a high-performing sales team as well as advanced manufacturing technique, comprehensive quality management system and modernized testing methods.

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