Sodium chloride: A simple compound that is irreplaceable as an active pharmaceutical ingredient

Shihlien Chemical Industrial Jiangsu Co. (實聯化工) has an annual output of 300,000 tons of sodium chloride raw materials and had been running full production capacity since the end of 2014.

TAIPEI (TCP) – Contemporary Western medicine, to allow different routes of administration such as oral, injection or topical smear, commonly comes in preparations like tablets, injections and ointments, which comprise an active ingredient that is combined with excipients. Such active ingredients are called active pharmaceutical ingredients (API), and they are sourced from the upstream of the pharmaceutical industry. Therefore, they are produced in manufacturing facilities and processes which are subjected to the same hygiene and safety requirements as those of the general pharmaceutical industry.

Shihlien Chemical Industrial Jiangsu Co. (實聯化工), which has invested US$1.3 billion in Jiangsu province’s Huai’an City, was established by investors led by Taiwan Glass Industry Corp. (台玻) President Lin Po-shih (林伯實). The company has an annual production capacity of 1 million tons, each, of soda ash and ammonium chloride and had been running full production capacity since the end of 2014. In pursuit of an industrial upgrade and transformation, it capitalized on the connection between salt and human life in 2014, developing a series of products based on sodium chloride and its production processes as well as value-added general biotechnology products.

One project in this venture was a US$50 million facility capable of producing 300,000 tons of sodium chloride API a year. Upon completion, this plant will become the world’s largest manufacturer of API-grade sodium chloride.

Although the chemical structure of sodium chloride is extremely simple, it is an electrolyte in our body and is used to regulate the osmotic pressure of extracellular fluid, which has no substitute. There are two primary applications for its use in pharmaceuticals, namely preparations and hemodialysates. These two uses make up 31 percent and 39 percent of the API-grade sodium chloride market, respectively, according to a survey by market research group AskCI Consulting Co.

Preparations include sodium chloride physiological intravenous infusion, sodium chloride injection, concentrated sodium chloride injection, Ringer’s solution and compounded sodium chloride injection. Hemodialysates are used to treat renal failure as well as in dialysis treatments. Since API-grade sodium chloride is manufactured in an environment governed by stringent hygiene and safety standards, they can also be used in the household, chemicals and food industries.

Sodium chloride accounts for about half the weight of hemodialysates, so the demand for this product is closely tied to the overall demand for sodium chloride. According to research by Beijing University Hospital Professor Wang Hai Yan published in the U.K. medical journal Lancet, the morbidity rate for chronic kidney disease of adults in China is as high as 10.8 percent, which means an estimated 150 million people in 2016 suffered some degree of renal impairment.

Going by the statistic that 1.5 percent of chronic kidney disease in the U.S. develops into end-stage renal disease, which requires hemodialysis, it is estimated that there are about 2.39 million patients in mainland China with end-stage renal disease. But at present, only 340,000 patients are undergoing regular dialysis treatment — about 14 percent of the total projection. This percentage is well below the global average of 37 percent and the 75 percent average in developed regions like Europe, the U.S. and Japan, indicating that there is a significant unsatisfied need for treatment that will lead to an increased demand for API-grade sodium chloride. 

The China Post staff