The quality specification and safety level of medicinal […]
The quality specification and safety level of medicinal hollow capsules will become a key factor affecting the development of the industry. With the transformation and upgrading and structural adjustment of the downstream pharmaceutical industry in the future, and the further improvement of the pharmaceutical excipient management system by the national drug regulatory authorities, it is inevitable to require the quality level, technical process and supporting of the pharmaceutical hollow capsule production. Greatly improved, thus promoting the concentration of the pharmaceutical hollow capsule industry to specialized and large-scale enterprises. The future development trend of the industry will be mainly reflected in the following aspects:
(1) The production management of the industry tends to be standardized, and the specialized and large-scale pharmaceutical hollow capsule enterprises will occupy the dominant position in the market.
In August 2012, the State Food and Drug Administration issued the “Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients”, further clarifying the main responsibility of pharmaceutical excipients, and supervising the pharmaceutical hollow capsule industry with reference to the management mode of APIs. . Since medicinal hollow capsules are pharmaceutical excipients with national standards, in addition to continuing to strengthen the original licensing management model, pharmaceutical hollow capsule enterprises will be required to strictly implement the "Quality Management Standards for the Production of Pharmaceutical Excipients" to improve the access of production enterprises. threshold. The soundness of the supervision and management system will significantly improve the standardization and standardization of pharmaceutical medicinal hollow capsule enterprises in terms of production conditions, process standards, quality control and other aspects, so as to ensure the safety and effectiveness of medicinal hollow capsules meet the standard requirements. With the gradual deepening of the standardization and standardization process of the medicinal hollow capsule industry, the production enterprises that do not meet the production quality management norms in the industry will be eliminated by the market, thus providing a good development space for the standardized pharmaceutical hollow capsule production enterprises.
At the same time, with the gradual implementation of the "Quality Management Standards for the Production of Pharmaceutical Excipients", the investment in standardization and specialization of production management will gradually increase, and large-scale enterprises will occupy a significant cost advantage. In addition, with the pharmaceutical industry in China With the continuous development of industry and the continuous deepening of pharmaceutical research and development, pharmaceutical companies are increasingly demanding the standardization and specialization of medicinal hollow capsules, such as having a good chance of capsules and high quality stability. Therefore, specialization and scale will be the development trend of the future pharmaceutical hollow capsule industry.
(2) Industry concentration will be significantly improved
As a kind of medicinal excipients, the medicinal hollow capsule industry has a situation of “small, scattered and chaotic”. Some capsule production enterprises have irregular production quality management and the product quality level is unstable. With the rigorous review and control of medicinal hollow capsule enterprises in terms of qualification standards and quality management, the industry entry threshold will be greatly improved. At the same time, enterprises with high industry reputation, brand influence, quality management regulations and rich customer resources will further expand their market share through mergers and acquisitions and restructuring. Therefore, with the consolidation of industry and supervision, small-scale pharmaceutical hollow capsule enterprises will be under greater pressure, the number will also be greatly reduced, and the industry concentration will be significantly improved.
(3) The quality and safety standards of medicinal hollow capsules are getting higher and higher
The safety of medicinal hollow capsules mainly comes from two aspects: the safety of raw materials and the safety of residues during preparation. On the one hand, national drug standards have further improved the control standards for residues in raw materials and preparations. The Chinese Pharmacopoeia (2010 edition) has added tests for three indicators: “chromium”, “ethylene oxide” and “paraben”. At the same time, the "heavy metal" inspection standard is changed from the original "not more than 50 parts per million" to "not more than 40 parts per million"; the basis for reducing the concentration of liquid iodine solution and the amount of standard potassium sulfate solution In the above, the test limit of "sulfite" was tightened from the original 0.02% to 0.01%. On the other hand, the “Regulations on Strengthening the Supervision and Administration of Pharmaceutical Excipients” require extended inspections of enterprises, strict control of raw materials procurement to factory inspections, and establishment of a database of pharmaceutical excipients to record the production, use and sales of pharmaceuticals. It can be foreseen that with the continuous improvement of the regulatory system for pharmaceutical excipients, the quality and safety standards for medicinal hollow capsules will be higher and higher.
(4) Rapid development of new medicinal hollow capsules such as non-animal-derived capsules
The demand for new medicinal hollow capsules such as non-animal-derived capsules mainly comes from consumer preferences and the special needs of modern medicine research and development and preparation. On the one hand, due to the international consumption trends of natural products and the increase in demand caused by vegetarian diets, the annual sales of non-animal capsules such as plant hollow capsules have increased rapidly; on the other hand, with modern pharmaceuticals The rapid development of learning, for some fillers that may cross-link curing reaction with gelatin, pharmaceutical production, research and development companies need more stable non-animal-derived capsules.
At the same time, the substitution effect of the price increase of gelatin hollow capsules will accelerate the research and development of new pharmaceutical hollow capsules. Relevant manufacturers in the industry have developed and developed hydroxypropyl starch hollow capsules through acquisition and merger. Erkang Pharmaceutical has established a complete industrial chain from cassava raw materials to intermediate products to starch plant capsules through the acquisition of Changsha Zhengyang Medicinal Capsule Co., Ltd. and Zhongshan Kaibosi Starch Material Technology Co., Ltd. Plant hollow capsule industry layout speed; At present, Erkang Pharmaceutical has invested in a non-public offering to invest in the project of “100 billion starch plant hollow capsules per year and 30 billion starch plant soft capsules per year” to further increase the starch capsule hollow capsules. Input. New medicinal hollow capsules, such as breaking through technical barriers and changing market consumption habits, will successfully impact the traditional pharmaceutical hollow capsule industry after successful scale production. With the rapid development of China's pharmaceutical industry, the diversification of the types of pharmaceutical preparations will drive the demand for new pharmaceutical hollow capsules and promote the rapid development of China's pharmaceutical hollow capsule industry.