Sterile pharmaceutical company GMP certification set off a hot climax in the pharmaceutical industry

The GMP certification of sterile drug manufacturers raised a feverish climax in the pharmaceutical industry. In 2014, only Sicheng enterprises passed the certification, but this is not the end. Besides sterilization drug manufacturers, the new GMP also stipulates the production of other drugs. The company must pass the certification by the end of 2015, otherwise it will be difficult to escape the suspension of production.

For the remaining two-year transitional period, 2014 will surely become a large-scale new GMP reform start year related experts pointed out: Based on the experience of the first version of GMP certification, the earlier the company successfully passed certification, its The more advantage of sales bidding.

Even if companies that have not passed the new GMP certification have expanded their production before the expiration of the deadline, they can store several quarters of their products and maintain their supply for a period of time, making the sales of GMP-certified companies unlikely to burst in the short term.

However, from the flexibility of the pharmaceutical market in 2014, the obvious benefit will be the relatively low-end varieties in the field of injections. For example, the market concentration of antibiotic injections such as Cologne Pharmaceuticals, China Resources Double Crane, etc. will be higher. The speed will be gradually released, which is not bad for companies that have passed the new GMP certification.

Therefore, as long as there is a certain strength or ability of the company will implement the new version of GMP transformation as soon as possible, will not wait and see attitude in 2015 to apply for extension.

In addition, there are numerous pharmaceutical manufacturing enterprises in China, and the overproduction of pharmaceutical production capacity is relatively prominent. Taking a freeze-dried powder injection in a sterile pharmaceutical manufacturing company as an example, only 20% of companies that have passed the new GMP certification will be able to supply nearly 70% of the market demand. This fully illustrates the problems in the structure and production capacity of China's pharmaceutical industry. .

In 2014, as a large-scale new GMP reform startup year, relevant companies should learn lessons from the early stage. In the new year, other pharmaceutical manufacturers need to continuously strengthen technological transformation and strive to achieve certification as soon as possible.