Views:96 Author:Site Editor Publish Time: 2021-03-19 Origin:Site
Sandoo, as a professional API manufactruer in China, we produces a wide range of active pharmaceutical ingredients which can be used in the production of medicines in different applications. Our products are produced under strict procedures and cGMP (Current Good Manufacturing Practices). In addtion, we can also customize new pharmaceutical compounds for new drugs.
Table of Contents
API in Pharma
Common Questions about API
Regulations in Pharmaceutical Industry
API in Pharma
API, as well as active pharmaceutical ingredient, means the active ingredient of a medicine. In the process of making drugs, an API plays an important role and acts as a real pharmaceutical agent in a medicine.
For example, Olopatadine hydrochloride is a medication used to decrease the symptoms of allergic conjunctivitis and allergic rhinitis (hay fever). APIs (Isoxepac cas no. 55453-87-7 and (3-dimethylaminopropyl)triphenylphospho-nium bromo hydrobromide cas no. 27710-82-3) used in Olopatadine hydrochloride are active ingredients that is anti-allergic.
However, it's worth noting that APIs can't be taken by the patient directly. An API is just the active ingredient of a drug and can not be used as a drug. Only when an API is processed into pharmaceutical preparation, can it become the medicine for clinical application.
What is the difference between API and intermediates?
An intermediate is a chemical compund that is produced in the process of making an API. Intermediates are necessary and indispensable in the synthesis and manufacturing of APIs. In the production of APIs, Intermediates are the key products of the preceding processes.
How is an API in pharma produced?
In the process of API production, we may be confused be several concepts such as raw material, intermadiates and API. What's the difference? Raw materials are chemical compunds used as a base to make APIs. Under complex reactions in the large reactor in our plant, raw materials are processed into APIs. The chemical compound which is in the process of becoming as an API from raw material is an intermediate. Every API we produces passes through over many kinds of intermediates in the production. From raw material to APIs, an chemical compound is purified time and time again until it reaches a high degree of purity. Finally, APIs are produced.
What's more, any kind of API has to be manufactured under cGMP (Current Good Manufactuing Practices) and distributed under GDP (good distribution practices) for pharmaceuticals.
Where are APIs made?
The largest API manufacturers are located in Asia, particularly in China and India.
The overall scale of China's API industry is large. Data shows that China is the largest producer and exporter of APIs, producing more than 1,500 APIs and intermediates. There are national API manufacturing bases in China. With the continuous upgrading of Chinese API enterprises in terms of production technology, scale and quality, Chinese API manufactuers will make further progress in the international market in the future.
APIs are generally manufactured through biological and chemical processes. With the rapid development of the pharmaceutical industry, the role of API manufacturers in the pharmaceutical market is constantly changing. Therefore, eguipments and technology used in API production are also updated to adapt to the changes in the industry.
Common API manufacturing technologies
Chemical synthetic API refers to the production method of API in which various chemical raw materials in industrial production can obtain products with certain efficacy through chemical reaction under certain conditions. Then,through crystallization, drying and other processes, APIs produced can reach various indexes of the medicine.
Fermentation is also one of the important ways in API production processes, especially antibiotic API, such as penicillins and cephalosporins which are usually obtained through the semi-synthesis of fermentation and chemical synthesis.
Firstly, the main structure of the target compound, such as the penicillin specific 3-lactam structure, was obtained by biological fermentation, and then the final target compound was obtained by structural modification. Finally, it is refined and recrystallized to obtain the final API product. The fermentation process generally needs to go through the preparation of culture medium, dissolving pot treatment, inoculation, fermentation, wall breaking, filtration, precipitation, centrifugation, drying and other processes.
Similar to sterile preparations, sterile API is also divided into sterile API with final sterilization and non-sterile API with final sterilization. However, since most APIs are sensitive to high temperature, high humidity, high pressure, radiation, etc., few sterile API with final sterilization are adopted.
At present, non-final sterilization of sterile API is usually combined with the refining or salting of the last step of the product and the sterilization process, and the final product is sterile by pre-filtration and two-stage 0.22um sterilization filtration. The sterile API product is usually obtained by crystallization, lyophilization or spray drying of the filtrated solution after sterilization.
Compared with non-sterile API, the production of sterile API not only needs to pay attention to the requirements of chemical quality indicators such as impurities and physical and chemical properties of the product, but also needs to pay attention to the guarantee of sterility of the product from the beginning of process design. Therefore, the production of sterile API has higher requirements on the environment and equipment.
animal and plant extraction
Nature is a treasure house of natural compounds. Animals or plants, through their own metabolism, produce many compounds that cannot be synthesized at present but are of great significance for the treatment of diseases. Therefore, animal and plant extraction is an important way to obtain target compounds, and also one of the main ways to produce APIs.
Characteristics of API Production
It often involve complex chemical and or biological processes.
It has a more complex intermediate control process.
By-products are often produced during the manufacturing process and purification processes are usually required.
Different varieties of production equipment are sometimes used for different reactions.
The same apparatus may sometimes be used for different reactions.
The degree of automation is getting higher and higher, the application of automatic production facilities and equipment and process analysis technology is increasing.
The mechanism of some chemical and biological reactions is not fully understood.
Contamination is more likely to come from the degradation of the material in the equipment, which may be carried to other equipment with the process.
As key materials of medicines, active pharmaceutical ingredients (APIs) plays an important role in the production of drugs in pharmaceutical industry. The quality and the stability of APIs are crucial factors in the overal quality, safety and efficacy of medical products. Therefore, there are strict regulatory requirements for active pharmaceutical ingredients which all API manufacturers must strictly ahere to.
There are different regulations about APIs in different countries. Roughly speaking, we may characterise the period that lies behind us as one of a "double standard" of regulatory requirements for the manufacturer of APIs: the level demanded by the US FDA and that required by the rest of the world. APIs produced by the manufacturer have to meet cGMP (Current Good Manufactuing Practices) requirements and standards of regulatory in the place where APIs are sold to.
For example, APIs used in the manufacture of medicinal products market in the US have to meet all the regulatory of FDA (The US Food and Drug Administration) .
In addition, the pharmaceutical industry is closely related to health and life quality of human beings. That means every step in the production of medical products is crucial and pharmaceutical manufacturers have to strictly abide by restrictive requirements in pharma industry.
Sandoo, a professional API manufacturer in China, is dedicated to manufacturing high quality active pharmaceutical ingredients (APIs) strictly adhere to restrictive standards and requirements in pharma industry since we establish. We provide a wide range of APIs to satisfy customers' various needs.