Artemether, Guilin Pharma’s First WHO-certified API

Guilin Pharma has received its first WHO product quality certification for the anti-malaria drug Artemether, paving the way for other drugs in its portfolio.

AsianScientist (Jun 23, 2014) – Guilin Pharma’s active pharmaceutical ingredient (API) Artemether has received the product quality (PQ) certification by the World Health Organization (WHO) and has been included in the WHO’s PQ certified API list for global buyers.

Artemether is an anti-malarial drug for the treatment of multi-drug resistant strains of Plasmodium falciparum. First isolated from the traditional Chinese herb Artemisia annua in the 1980’s, it is now on the WHO list of essential medicines, a baseline list of important drugs required in a basic healthcare system.

Guilin Pharma, a member of the Fosun Pharmaceutical group, has been actively applying for the API-specific PQ certification since its initiation in October 2010. The Artemether API product line API-II passed the WHO good manufacturing practices (GMP) inspection in July 2012 and received the acceptance number and the first round review comments in August of that year. A total of 42 questions were raised involving all aspects of physico-chemical property, process validation and impurity control; which challenged the company’s process control and research analysis.

After an extensive analysis of the company’s process control and research procedures, Guilin Pharma submitted the first round response in November 2013. The subsequent inspection schedule was then confirmed with WHO on May 16th, 2014. Following a single round of response, Guilin Pharma’s Artemether API successfully passed the PQ certification on May 27th, 2014.

This approval marks Guilin Pharma’s first API-specific PQ certification by WHO, setting the stage for more of Guilin Pharma’s APIs to go global.


Source: Fosun Pharma.
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