Pharmaceutical materials include active pharmaceutical ingredients (APIs) and the necessary chemical intermediates or basic materials. The former requires approval by national-level health authorities before being allowed on the market, while the latter are sophisticated chemical agents, most of which are not as rigorously regulated in other countries.
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Continuous innovation to meet the technological requirements of APIs
With regard to the manufacturing process, APIs can be divided into chemical synthetics, ferments, animal or botanical extracts, and proteins manufactured via biotechnological methods (such as genetic engineering or cell fusion). APIs further undergo mixing with non-pharmaceutical ingredients (excipients) to make the drugs user-friendly to pharmacies and hospitals. |
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CCSB is one of the few API manufacturers with both chemical synthesis and fermentation capabilities
CCSB has developed unique bulk manufacturing know-how in compliance with GMP standards. Today, approximately half of our revenue comes from fermentation products, including the lipid-lowering agent Pravastatin sodium and immunosuppressive agents such as Tacrolimus, Rapamycin, and Mycophenolate mofetil. These APIs occupy an important niche in European and American markets. |
Developing APIs relies not only on technology but also on the ability to avoid patent problems
The technology involved in the development of generic drugs is highly sophisticated because intellectual property rights are taken seriously in medically advanced countries. From chemical structures of pharmaceutical agents to the manufacturing process of APIs and drugs, patents offer a multitude of protections. Therefore, manufacturers of generic drugs and APIs must not only develop new methods to avoid potential patent problems, they must also ensure consistency of the quality of the end-products with the brand name counterpart (bioequivalency). If new methods used result in new impurities, impurity content cannot exceed 0.10%, which is a significant technological challenge. |
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CCSB has successfully avoided patent issues in order to enter European and American markets
After certification by the FDA and by clients, CCSB has successfully begun distribution in European and American markets, from which approximately 80% of our revenue now comes. This is a clear indication that we already have a foothold in the international generic drugs market. This also implies a competitive edge over China and other regions where low-cost manufacturing is the mainstream. |
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Manufacturers of pharmaceutical raw materials need excellent management systems and the ability to react quickly
When health authorities grant a client approval to distribute a product, only then will the API manufacturer commence bulk productions to meet client needs. To minimize the risk of overstocking, only small samples of APIs are sold to clients for testing purposes and for data gathering for application documents needed for marketing approval. The quantity of GMP samples comprises only what is necessary for production registration, far less than the amount needed for distribution purposes. Once market approval is granted scaling up for bulk production is another challenge entirely. |
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We have confidence we can be your API partner
CCSB is highly experienced in and capable of quickly reacting to various situations to meet the special needs of this industry. |
The high-risk nature of the API industry
The export of APIs is not restricted by the Bureau of National Health Insurance's budget constraints, but its international marketplace is fiercely competitive. Furthermore, authorization timelines are uncertain, increasing the unpredictability of this industry. |
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CCSB has entered a phase of steady profits
CCSB is highly experienced in the management of the life cycle of APIs. Through years of hard work, and with subsequent patent expirations and the commencement of distribution of our clients' products, our profits have grown steadily and significantly. |
For more product information, please see
Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB)
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