YaoPharma Got the Health Canada GMP Certification
In November 2010, good news came constantly from Fosun Pharmaceutical’ pharmaceutical enterprises, not long after the approval of Guilin Pharma Co., Ltd’ supplier qualification of Artesun by World Health Organization (WHO) , on November 23, Chongqing YaoPharma successfully passed Health Canada GMP certification, which was also the first transcript handed over by YaoPharma since the implementation of internationalization strategy.
It is reported, YaoPharma is the first pharmaceutical enterprise which obtained prescription medication passed by Health Canada GMP certification. At the same time, Canada, as the GMP mutual recognition agreement country with the European Union, Australia and New Zealand and the organization member of PIC/S, YaoPharma passed the GMP certification, which also meant that it entered into the first threshold of the PIC/S28 countries. It enabled YaoPharma to accumulate valuable experience in accepting the further certification inspection by other western countries, and laid a solid foundation for its international development. It was the first battle to overcome technical barriers of international pharmaceutical market.
Cui Zhiping, vice president and general manager of Fosun Pharmaceutical said that Many domestic large pharmaceutical enterprises hope to export generic drugs to Europe and the United States and other predominant medical market earlier, YaoPharma, as one of the core members of Fosun Pharmaceutical, already lead in the front.
In recent years, Fosun Pharmaceutical actively boosts its globalization, takes advantage of Chinese market, resources and cost advantages, aims at the global mainstream market, and follows the globalization path of combination of created in China and made in China. In the pharmaceutical manufacturing, Fosun Pharmaceutical requires its members to strengthen GMP management, and invests in and transforms the existing enterprises, so as to gradually reach the international standard of cGMP. It is known that YaoPharma has invested RMB 200 million to implement the long brewed internationalization strategy since 2008, project team is specially set up, with Liu Qiang as chairman of the board, president Wang Fan, vice President Ha Qing, directly responsible for cGMP project and plant cGMP transformation work. The company has introduced international first-class preparation production equipments from Germany and Italian, rebuilt large warehouse in compliance with standards for cGMP, remodeled workshop and facilities, and at the same time, it also actively improved software level, and introduced senior management and technical talents overseas and from international famous pharmaceutical enterprises, and strengthened cGMP training to workers at the production line, so as to make their operation more standard. The production file system and audit method gradually meet the standards of GMP in developed countries.
On October 18, 2010, after two years’ technical transformation, YaoPharma received the six-day on-site inspection by authentication officials from Health Canada. The company has already invited the GMP experts at home and abroad in advance to carry out on-site simulating inspections and related trainings, and made careful analysis and improvement to the defects put forward in the inspection. Owing to the great attention the company paid and the full preparation, and joint efforts of all the staff, YaoPharma passed the on-site inspection by Health Canada on the first try. It means that YaoPharma has fully complied with Canada GMP standard in the aspect of the workshop, equipment, environment, personnel, file system and quality management system and so on, the products manufactured will satisfy the quality requirements of the western mainstream medical market
Company Profile:
Chongqing YaoPharma Co. LTD. is a pharmaceutical enterprise group held by Shanghai Fosun Pharmaceutical, integrating the R&D, production and sale of pharmaceutical preparation and API as a whole, it has several subsidiaries compliance with the standards of GMP.
After seventy years’ development, YaoPharma has become a quality-driven, profit-oriented and high-tech technology enterprise, with annual sales revenue over RMB 1 billion, annul tax RMB 100 million, and it established the international first-class and national largest Lyophilized preparation production line, represented by atomolan and andrographolide, which takes dominate market position in the similar products market. 90% of API products are exported to America and Europe market, and YaoPharma has become the largest supplier of clindamycin hydrochloride, and forms the competitive products effect under its enterprises brand, as well as the high tech, high standard and professional core competitiveness.
In the future, YaoPharma set higher goal, that is to implement the international strategy to enlarge the overall enterprise scale, through the endogenous and denotative development, and try to make YaoPharma the most outstanding Chinese pharmaceutical preparations companies and China's leading API global supplier, realizing the dream of becoming a ten billion RMB and hundred year enterprise.