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What are APIs, Original Research Drugs and Generic Drugs?

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The bulk drug is a kind of compound, because it is impossible for the compound to have perfect physical and chemical parameters to achieve the greatest effect in the complex environment of the human body, so the regular original research drug needs to use various excipients and dosage forms to achieve the curative effect. Chemical custom synthetic APIs are generally understood to be customized according to the requirements of drug manufacturers, and their use is for pharmaceuticals.

With the development and growth of the custom synthetic CRO industry in China, more and more new enterprises and companies have joined. Medicilon can synthesize reference compounds, intermediates, candidate drugs, impurities and metabolites for customers. A small molecule chemical substance, its scale can range from milligram level to kilogram level (including GMP quality). The original research drug refers to the original new drug, which has been approved for marketing only after tens of thousands of compounds have been screened and rigorously tested. A generic drug refers to a generic product that is the same as a brand-name drug in terms of dosage, safety and efficacy (no matter how it is taken), quality, effect, and indications. Let’s briefly introduce what are APIs, original research drugs and generic drugs.


APIs are the upstream of normal pharmaceuticals. Strictly speaking, APIs are not directly “eaten” for patients, because they are not medicines, but like other chemical products, they are just raw materials. For a drug, the active ingredient of the drug is the main ingredient of the drug, and the other ingredients are called “excipients.” Xiangyao has a special acid-base coefficient and requires precise dissolution in the preparation, so as to ensure that it disintegrates at the correct time when it reaches the gastric acid environment, dissolves at the correct speed, and obtains the appropriate absorption rate.

Medicilon currently features a cGMP-based API production line based on IND requirements. From preclinical laboratory-scale testing and process development to commercialized production, we meet the needs of our clients throughout the comprehensive supply chain, including R&D, purchase and production. From the mg- and g-level to kg level, our processes allow flexible adjustments to fit in client innovative process R&D and scale production.

Some APIs in China are actually synthesized by a few people behind closed doors, because the chemical formula of the drug is public. With this chemical formula, anyone with a little knowledge of chemistry can synthesize it. However, self-made preparations may disintegrate too early or too late due to the differences in excipients and tableting. If they are too early, they may cause mucosal irritation to the esophagus and stomach. If they are too late, they will not be fully absorbed in the stomach and enter the intestinal tract. The pH environment is not easy to absorb, and the drug dosage is difficult to achieve, which may affect its therapeutic effect.

Many patients use raw materials because of price factors or the inability to buy original research drugs in China. This situation may not only fail to exert the efficacy, but also cause other undesirable results due to improper use. Targeted drugs can’t take the raw mateRrials directly. Targeted drugs are mainly used in the preparation process to achieve the targeted delivery step of the drug. If the targeted raw materials are taken naked, the drug will only run in the body according to the normal digestion process, but not Directional transport to the diseased part.

Original Research Drug

It is called a genuine drug in China, but it is called original research drug in European and American countries. It refers to an original research and development drug. After tens of thousands of compounds have been screened and rigorously tested, they have been approved for marketing. The original research drug needs to spend as short as 5 years, as long as 15 years of research and development time and hundreds of millions of dollars of investment, so the market price is very high, and this is also a reason.

The general steps to go through the marketing of the original research drug: project establishment (4 months); preclinical research (9-24 months); clinical research application (more than 1 year); clinical trial approval documents; clinical research (3-5 years); production Application (1 year-n years); review and on-site inspection after acceptance of the notice; approval for production and marketing (about 6 months); monitoring period. This is also the reason why genuine drugs are called “expensive drugs”, and the cost invested during the period will take a certain amount of time to recover. For some genuine medicines that are already on the market in China, if the family economy allows, the genuine medicines can be given priority.

Generic Drug

A generic drug refers to a generic drug that is the same or similar to the original drug (original drug) in terms of dosage, safety and efficacy, quality, effect and indications.

Because of the patent protection of tumor drugs in China, it is difficult to see that there are tumor generic drugs in China. However, India, the world’s major imitation country, has simply ignored the intellectual property choices of pharmaceutical companies in Europe and the United States because of the creation of the “Medical Patent Compulsory Demand Certificate”, and then imitated and sold some oncology drugs, and the price was far from the genuine drugs. India’s laws stipulate that its own pharmaceutical companies can imitate global drugs for their citizens. Even the US FDA has approved 650 Indian pharmaceutical companies to export generic drugs to European and American countries.

For example, some anti-tumor drugs are sold for tens of thousands of yuan in genuine versions. Many ordinary families want to use the drugs, but they have more than enough energy and cannot afford the drugs. The average price of generic drugs is about several thousand yuan, which brings hope to many families. However, there are also fake drugs in India. Counterfeit medicines are usually foreigners who go to India to open a small illegal processing plant to produce fake medicines and then sell them to China. Therefore, when choosing generic drugs, you must choose a legal and compliant overseas medical institution or company. If it is possible, it is best to go to India and prescribe the drug with a prescription, or carefully choose to have patients who go to India to help buy it. Both are one of the ways to ensure the safety of medicines.

The price difference between the original research drug and the generic drug is relatively large, which is actually due to the following reasons:

(1) For the original research drug, research and development is an extremely complicated process.

From development to marketing, high-throughput screening, physical and chemical properties, in vitro screening, in vivo screening and other clinical studies are required; phase I phase II and phase III clinical research; on this basis, it can be marketed after registration. The research and development of an original drug requires an average of 4,000 chemical structures, which takes 10-15 years, and the average investment is as high as US$300-500 million.

(2) For generic drug manufacturers, they save the cost of drug R&D and marketing. On average, a generic drug can be marketed for sale in 3-5 years, and the cost is generally less than US$240,000. The natural price of this low-time-consuming, low-cost, and low-promotion drug is also much lower than the original research drug.

Regardless of whether it is a generic drug or an original drug, for cancer patients, it is the luckiest thing to have a drug that suits their condition. Many patients choose generic drugs because the original drugs are more expensive. Generic drugs are not only much cheaper than original drugs in terms of price, but also many patients have obtained good curative effects and their conditions are under control.

For patients with malignant tumors, careful selection of drugs from regular sources is the top priority. In the process of drug selection, you should keep your eyes open, stay away from raw materials, and reasonably choose original drugs and generic drugs within the scope of economic affordability.

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