Artesunate Injection from Guilin Pharma Passed WHO-PO Attestation

On Nov. 4th, from the closing letter sent by WHO, Guilin Pharma has learnt that through GMP on site inspection, its Artesunate injection workshop has already been attested to conform to WHO-GMP normative. On Nov. 5th, WHO official website has listed Artesunate injection (Artesun) of Guilin Pharma on the PO drug list.

Therefore, Guilin Pharma has become the first domestic injection manufacturer that passed WHO-PQ certification, which will improve the influence of Guilin Pharma, even Chinese pharmaceutical industry during the international industry, and also will speed up its product R&D and international market expansion.

As a subsidiary of Fosun Pharma, Guilin Pharma is the inventor of Artesunate while it is also the only manufacturer for water-soluble Artesunate injection. Since May of 2005, Guilin Pharma has set to apply to WHO for PQ Attestation to Artesunate injection. As early as in 1977, Guilin Pharma had chemically synthesized Artesunate on the based of Artemisinin.

In 1987, China adopted provisions for new drugs approval when Artesunate had got No.1 certificate for first new drugs while Artesunate injection had got No. 2 certificate. Through passed over 20 years persistent R&D, Guilin Pharma has improved a lot on the Artesunate s material and injection quality.

Currently, the Guilin Pharma s production capacity for Artesunate injection is 6 million pcs/year while the annual capacity utilization rate of 2009 is 33%. The Artesunate from Guilin Pharma has passed Supplier Qualification of WHO while Artesunate injection has even been recommended by WHO as the first choice for malaria first aid.