Huons said Friday that it has received good manufacturing practice (GMP) certification for its injection, eye drop and solid formulation manufacturing line from the Saudi Food and Drug Authority (SFDA).

The approval comes eight months after the Saudi health authorities inspected the company’s three manufacturing line.

The company expects that the Saudi’s GMP certification will help expand its export in the region as it will now be able to receive GMP certification from Gulf Cooperation Council (GCC) countries such as Kuwait, UAE, Bahrain, Oman and Qatar with minimum requirements.

“The Middle East market is a pharmerging market with a strong market potential due to continuous population growth and long life expectancy,” the company said in a statement. “Most of all, Saudi Arabia, with a population of approximately 30 million, a is the largest pharmaceutical market in the Middle East, accounting for 60 percent of the Middle East's overall pharmaceutical market.”

Therefore, the country has strict GMP regulations, which makes it difficult to obtain GMP certification, the company added.

The company is discussing its injection price with Salehiya, its local partner, and plans to launch the product as soon as the two companies reach an agreement.

The annual injection market size in Saudi Arabia is approximately 3.8 million ampoules, and the country is in need for additional injection suppliers as Hospira, the primary supplier in the region, is suffering from a lack of supplies.

“With successful results in Saudi Arabia, where GMP certification is difficult to obtain, the company has now secured a bridgehead for entering the Middle East,” Huons CEO Um Key-an said. “The certification is a great feat for the company as pharmerging markets like the Middle East has a growth rate of 7 to 10 percent.”

Beginning with its injection products, the company plans to expand into the Middle East market by also launching eye drops solid formulations, Um added.

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