Views:52 Author:Site Editor Publish Time: 2021-05-10 Origin:Site
What are pharmaceutical intermediates?
Pharmaceutical intermediates are actually chemical raw materials or chemical products that need to be used in the synthesis of drugs. Such chemical products can be produced in ordinary chemical plants without obtaining a pharmaceutical production license. As long as the technical indicators meet certain level requirements, they can be used to participate in the synthesis and production of drugs.
Although the synthesis of medicines also belongs to the chemical industry, it has stricter requirements than general chemical products. Manufacturers of finished medicines and APIs need to receive GMP certification, while manufacturers of intermediates do not, because intermediate products are only the synthesis and production of chemical raw materials, which are the most basic and bottom-end products in the drug production chain, and cannot be called It is a medicine, so it does not require GMP certification, which lowers the industry's entry barrier for intermediate manufacturers.
Pharmaceutical intermediates can be divided into antibiotic intermediates, antipyretic and analgesic pharmaceutical intermediates, cardiovascular system pharmaceutical intermediates, and anti-cancer pharmaceutical intermediates according to their application fields. There are many types of specific pharmaceutical intermediate products, such as imidazole, furan, phenol intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing, nitrogen-containing, halogen compounds, heterocyclic compounds, starch, mannitol , Microcrystalline cellulose, lactose, dextrin, glycols, powdered sugar, inorganic salts, ethanol intermediates, stearates, amino acids, ethanolamines, potassium salts, sodium salts and other intermediates, etc.
How is pharmaceutical intermediate produced? (pharmaceutical intermediates manufacturing
The first step is to participate in the customer's new drug development stage, which requires the company's R&D center to have strong innovation capabilities.
The second step is to enlarge the customer's pilot products to meet the process route of large-scale production. This requires the company's ability to scale up the product and the ability to continuously improve the process of customized product technology in the later stage, so as to meet the needs of large-scale production. Continuously reduce production costs and improve product competitiveness.
The third step is to carry out process digestion and improvement of the products in the mass production stage of customers, so as to meet the quality standards of foreign companies.
Our team is proficient in new route design and route optimization. With the proficient problem solving skills and the high success rate of the project, we are able to provide customers with the following high-quality chemical custom synthesis services:
Preparation of high-quality products from milligrams to kilograms
Synthesis of special reagents, pharmaceutical intermediates and preparation of molecular fragments
Preparation of APIs or related substances
What is the overview of development of pharma intermediates industry in China?
The pharmaceutical intermediate industry refers to those chemical companies that use chemical synthesis or biosynthesis methods to produce and process organic/inorganic intermediates or APIs for pharmaceutical companies to manufacture finished drugs in accordance with strict quality standards. Here, pharmaceutical intermediates are divided into two sub-sectors, CMO and CRO.
Contract Manufacturing Organization refers to the entrusted contract manufacturing enterprise, that is, the pharmaceutical company outsources the production process to the partner.
Contract (Clinical) Research Organization refers to a contract research organization commissioned by a pharmaceutical company to outsource the research process to a partner.
Pharmaceutical production requires a large number of special chemicals. Most of these chemicals were originally produced by the pharmaceutical industry. However, with the deepening of social division of labor and the advancement of production technology, the pharmaceutical industry has transferred some pharmaceutical intermediates to chemical companies for production. Pharmaceutical intermediates are fine chemical products, and the production of pharmaceutical intermediates has now become a major industry in the international chemical industry.
At present, China's pharmaceutical industry needs more than 2,000 kinds of chemical supporting raw materials and intermediates every year, and the demand exceeds 2.5 million tons. Since the export of pharmaceutical intermediates is not subject to the various restrictions of the importing country like the export of pharmaceuticals, and the transfer of the world's pharmaceutical intermediate production to developing countries, the current chemical raw materials and intermediates required for China's pharmaceutical production can basically be matched, only a small part of it import. Moreover, due to China's abundant resources and low raw material prices, many pharmaceutical intermediates have also been exported in large quantities.
As an important industry in the field of fine chemicals, pharmaceutical production has become the focus of development and competition in the past 10 years. With the advancement of science and technology, many medicines have been continuously developed to benefit mankind. The synthesis of these medicines depends on new and high-tech industries. For the production of high-quality pharmaceutical intermediates, new drugs are protected by patents, but there are no problems with the intermediates that are matched with them. Therefore, the development space and application prospects of the new pharmaceutical intermediates at home and abroad are very promising.
Sandoo Pharmaceutical is one of the leading pharmaceutical drug intermediates and API manufacturers in China. We specialize in the manufacturering of a wide range of high quality pharma intermediates. You can contact us to know more details or search the product by CAS number or product name.