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ILE Obtained The First Registration Approval For Croscarmellose Sodium In China
Nov 15, 2018

ILE obtained the first registration approval for croscarmellose sodium in China


Croscarmellose sodium (crosslinked CMC) is a kind of super disintegrant included in Chinese Pharmacopoeia for the first time in 2010, and is also an internationally recognized indispensable additive for production of new solid preparations such as efficient disintegrant, orally disintegrating tablet and rapidly disintegrating tablet. Crosslinked CMC is a derivative from natural plant cellulose, in the form of fine powder and easily mixable with other excipients. Even very low proportion (0.5-5%) of this disintegrant can present outstanding disintegrating performance. It is applicable for all tablet production processes, particularly directly compression process. The disintegration time limit and release effect of tablets made with crosslinked CMC do not change with time, showing excellent time stability. It has very good long-term stability in many preparations.


At present, the crosslinked CMC market in China is growing stably. Many famous pharmaceutical companies have listed this product as key item to be purchased. However, due to the market monopolization of European and American enterprises, and the high price and incomplete qualifications of imported products, many enterprises subject to cost control and strict GMP regulations have to abandon this product. The root cause for such dilemma is that no domestic enterprise is producing this product at present, and there is no domestically produced crosslinked CMC product with has high quality and can completely substitute imported ones.


As a well-known enterprise in excipient industry in China, ILE always takes the concept of leading technology, and has been devoting itself to importing and development of advanced excipient technology all along. To fill up the above-mentioned gap in the domestic market, with great efforts of all technicians of ILE in experiments and repeated demonstrations, ILE successfully obtained in 2011 the registration approval for crosslinked CMC from China Food and Drug Administration, which was the first and so far the only approval for this product in China. It has been demonstrated that the crosslinked CMC products developed by ILE itself meet the requirements of Chinese Pharmacopoeia, American Pharmacopoeia, European Pharmacopoeia and Japanese Drug Administration, and can completely substitute the same imported products. ILE filled up a gap in domestic excipient market again.


Product approval no.: Guo Yao Zhun Zi F20110001

Applicable standard: Standard YBF00012011 issued by China Food and Drug Administration





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