Recently, Amendment Pharmaceutical Sichuan Company was fined for using unqualified "low borosilicate glass controlled oral liquid bottles". This incident once again aroused the industry's attention to pharmaceutical quality, and the quality of pharmaceutical packaging materials has also become the focus of the industry.
Pharmaceutical packaging materials are "packaging materials and containers for direct contact with pharmaceuticals". The State Food and Drug Administration has strict regulations on the quality standards and inspection methods of pharmaceutical packaging materials, and will conduct random checks on its production and distribution links. According to Article 65 of the "Administrative Measures on Packaging Materials and Containers for Direct Contact with Drugs" reviewed and approved by the State Food and Drug Administration in 2004, the (Food) Drug Supervision and Administration Department shall order the use of unqualified drug packaging materials to be suspended In addition, a fine of more than 10,000 yuan but less than 30,000 yuan shall be imposed, and the medicine packaging materials of the packaged drugs shall be immediately recovered and supervised by the (food) drug supervision and management department.
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The quality of pharmaceutical packaging materials has a significant impact on the quality of pharmaceuticals. The industry believes that there is a gap between the efficacy of Chinese generic drugs and original research drugs. One of the important reasons is that the quality of domestic pharmaceutical packaging materials and excipients is uneven, and there is a certain distance from the international high-end level. According to international standards, the cost of raw materials should account for 50% of the total cost of generic drugs, and packaging materials account for 10%. However, most domestic medicines do not meet this standard, and the quality of domestic packaging materials and accessories needs to be improved.
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As the second largest pharmaceutical market in the world, China's pharmaceutical packaging materials and pharmaceutical excipients need to be more in line with international standards in approval. It is understood that CFDA has begun related review work, and driven by the consistency evaluation of generic drugs, the market size of imported pharmaceutical packaging materials and excipients is expected to increase significantly. Data show that in 2015, the market size of China's pharmaceutical packaging materials and excipients industry was 50 billion yuan. It is expected that by 2020, the market size of pharmaceutical excipients will increase to 100 billion yuan , with huge room for growth.
The market for medicine packaging materials and excipients is vast, and the country has begun to introduce various favorable policies to promote the upgrade of medicine packaging materials and excipients. It is reported that August 10, 2016, CFDA issued "No. 134" File "Administration Announcement on drug packaging pharmaceutical excipients associated with the review and approval of drugs and related matters (2016, No. 134)", marking China's kits The review and approval system for materials and pharmaceutical excipients is in line with international standards. The implementation of the new policy on pharmaceutical packaging materials and excipients will help the overall upgrade of the pharmaceutical packaging materials and excipients industry. A large number of new and high-end imported pharmaceutical excipients will enter the Chinese market. In the future, high-end packaging materials and accessories will become a development trend.
For Chinese pharmaceutical companies aiming at the international market, the search for high-end packaging materials and accessories has already begun. Xinhua Pharmaceutical, which focuses on the international market, is particularly cautious about the use of pharmaceutical packaging materials and excipients. The company representative said that high-end accessories are much higher than ordinary products in terms of decomposition and release. There are also differences in the quality of medicine packaging materials, especially those directly in contact with drugs, such as plastic bottles, aluminum foil and glass bottles.
With the continuous introduction of national policies, the relevant regulations have become stricter and stricter, and the pace of pharmaceutical companies in the search for high-end pharmaceutical accessories packaging materials is also accelerating. For example, the “consistency evaluation†of generic drugs emphasizes the related evaluation of medicinal packaging materials and pharmaceutical excipients, that is, to treat medicines as a whole composed of chemical raw materials, pharmaceutical excipients, and medicinal packaging materials. To ensure the safety of medicines is to require that there should be no errors in every link. Since the release of the "consistency evaluation" of generic drugs, pharmaceutical companies have begun to take "consistency evaluation" as the company's top priority in the past five years. It is naturally one of the important tasks to find high-end pharmaceutical packaging materials and auxiliary materials.
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The Chinese market's demand for pharmaceutical packaging materials and excipients is urgent. In order to complete the consistency evaluation, many Chinese pharmaceutical companies urgently need high-quality packaging materials and excipients. High-quality pharmaceutical packaging materials have become the most popular in the pharmaceutical market. To improve the quality of pharmaceutical packaging materials, pharmaceutical packaging material manufacturing machinery companies also need to constantly exert their efforts. They need to constantly innovate technology and strictly supervise each production process to ensure that the quality is qualified.
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