Because the patented pharmaceutical manufacturers only gave the pharmaceutical ingredients when the patent expired, but did not elaborate on the process of manufacturing drugs, in order to produce generic drugs consistent with the original research products, imitation pharmaceutical factories still need to make great efforts in research and development and process improvement. Therefore, generic drugs are not simple takenism.
The first China Viagra, Baiyunshan Jinge, took 16 years from research and development to production. More importantly, the research and development of Baiyunshan Jinge is aimed at the national first-class new drugs. It is reported that as early as the 1990s, before the original research products went on the market in the United States, Baiyunshan Pharmaceutical General Factory started the research and development of sildenafil citrate raw materials and tablets, and applied for clinical approval according to the requirements of new chemical drugs in China on 1998. In March, 20001year, it obtained the first-class clinical approval of new drugs from the State Administration of Pharmaceutical Products. In 2003, he obtained the certificates of new drugs such as raw materials and tablets. However, due to the fact that Pfizer's patent application in China was not approved, Baiyun Mountain suspended its application for registration of production approval.
The announcement of temporary grounding did not stop the pursuit of R&D personnel in Baiyun Mountain. Baiyunshan Pharmaceutical General Factory readjusted the R&D thinking of Jinge, constantly tracked the patents of the original research products, improved the Jinge process, and made deep excavation and bold innovation on sildenafil citrate. In June, 2004, 165438+ 10, the synthetic process of sildenafil citrate in Baiyun Mountain, "Intermediates for preparing sildenafil and its preparation method", was patented for invention. In June, 2005, another invention patent "Preparation Method of Pyridone" was also authorized. These process patents have obvious advantages in raw material preparation methods, which greatly improve the total yield.
Considering that the patent of Pfizer sildenafil citrate in China expired in May, 20 14, after comprehensive analysis and investigation, Baiyunshan Pharmaceutical General Factory started the research on the overall production of sildenafil citrate raw materials and tablets in 20 12. 20 12 "the father of viagra" and the Nobel Prize winner in Physiology and Medicine, Dr. Fried Murad, joined in, which greatly accelerated the application speed of production approval.
Under the guidance of Murad, the raw materials and preparations of Baiyunshan Jinge all follow the concept of "quality comes from design (QbD)". The crystal form, appearance, content, related substances, solubility and other indicators of the ginger produced by the self-designed synthetic route completely meet the requirements of the United States Pharmacopoeia and the European Pharmacopoeia for sildenafil citrate, which ensures the quality of ginger products from the source. At the same time, according to the consistency evaluation standard of China Food and Drug Administration, a series of research work has been carried out, and the related substances, content and dissolution behavior of Ginger are consistent with the original product. "Although the production process is different, the chemical composition of Jinge and Viagra is the same, and they have been strictly evaluated and approved by China's drug regulatory authorities." Dr Murad, the "father of Viagra", was interviewed by many media in Beijing on September 27th, and talked about the experience and significance of guiding the development of Jinge, especially pointing out that the quality of Jinge is consistent with the original research products. Emphasizing the development of generic drugs can reduce the price of drugs and benefit more patients.
After 16 years' persistence, Baiyunshan Jinge officially got the production approval and the "birth certificate", becoming the first Viagra in China.