Industry News
Current Situation, Trends and Opportunities of API Development in China
2019-09-07 17:21:52 Source:

Currentituation of China's API Industry

1.1 As one of the largest producers and exporters of APIs in the world, China's output and revenue of chemical APIs show a steady growth trend.

According to the statistics of the Price Supervision and Competition Bureau of the National Development and Reform Commission, China can produce more than 1500 kinds of APIs, with a total output of 1 million tons and an export volume of more than 60%. It has become the second largest API producing country and the largest exporting country in the world after the United States. In recent years, with the increasing number of patented drugs expiring, the variety and quantity of generic drugs have risen rapidly, bringing huge market opportunities for raw drug market and increasing the output of raw drug. At the same time, due to the increasing pressure of production cost and environmental protection cost in Europe and the United States, as well as the upgrading of process technology, production quality and registration and certification ability of pharmaceutical administration market in China's pharmaceutical raw materials manufacturing enterprises, a large number of pharmaceutical raw materials enterprises have accelerated their transfer to China, and the production scale of China's pharmaceutical raw materials industry has been increasing. According to statistics, the total output of chemical raw drugs in China reached 34.78 million tons in 2017, an increase of 1.6% over the same period last year.

The main business income of the chemical raw material pharmaceutical industry showed a steady growth trend, from 328.972 billion yuan in 2012 to 573.475 billion yuan in 2017, with a total profit of 48.644 billion yuan, but the profit margin remained at a low level, with a profit rate of 8.48% in 2017.

1.2 At present, China's API industry mainly concentrates on bulk APIs, and there is a huge space for development in special APIs and proprietary APIs.

In the chemical pharmaceutical industry, it is customary to classify APIs into three categories: bulk APIs, characteristic APIs and patent APIs. The characteristics of different categories are shown in Table 1 below.

(1) bulk APIs: overcapacity and low price

Bulk APIs mainly include vitamins, antibiotics and hormones. Among them, vitamin C, erythromycin thiohydride, penicillin, azithromycin and semi-synthetic cephalosporin are the most concentrated products in the industry. At present, there are more than 8000 pharmaceutical raw materials manufacturers in China, but they mainly produce bulk pharmaceutical raw materials with low technology content. With the advancement of supply-side structural reform, the production of bulk APIs in China will be more and more concentrated, and the process will be further improved. It can be predicted that in the future, the production capacity and output of bulk APIs in China will be reduced, the supply-demand relationship will be balanced, the price and profit will gradually return to a more reasonable range, the past era of low prices will never return, and even individual APIs may lose their competitive advantage in price and transfer to foreign countries.

(2) Characteristic APIs: Capacity continues to expand, target-locked original research drugs whose patent expires

Characteristic APIs, such as cardiovascular, antiviral and anti-cancer drugs, are targeted at imitation raw materials of patent-expired original research drugs. They have high scientific and technological content and rich profits. They are active APIs in China in recent ten years. They have been used by Huahai Pharmaceutical Industry, Chuangnuo Pharmaceutical Industry, Jiangbei Pharmaceutical Industry and other enterprises. The rise of industry has contributed a lot. In 2016, China's export of characteristic APIs reached 3.53 billion US dollars, accounting for 13.8% of APIs. With the patent expiration of 194 billion US dollars in the past five years, more and more domestic enterprises have focused on the corresponding characteristic APIs, and started the research and development and production preparations ahead of time. It is expected that the production and export scale of characteristic APIs in China will continue to expand and grow in the future.

(3) Patented Pharmaceutical APIs: China's CMO ranks first in the world, with a growth rate of 20%-30% in the future.

Under the environment of more and more close global capacity cooperation in the pharmaceutical industry, some multinational pharmaceutical companies choose to abandon the original whole industry chain model and shift their focus to market operation. R&D, clinical, production and other links are outsourced to reduce costs. Patented APIs emerge as the times require. The CMO market of Chinese medicine has maintained a growth rate of more than 10% in recent years. In terms of market structure, the average growth rate of clinical production is 9.5%, while that of commercial production is 18.7%. It is estimated that the market size of CMO in China has reached about 5 billion US dollars. With the implementation and further implementation of MAH system in China, it is expected to promote the outbreak of domestic pharmaceutical CMO industry. In the future, it is expected to grow at a rate of 20%-30%. Patented APIs account for a large proportion.

1.3 The concentration of API industry is obvious, but the distribution of enterprises is not balanced.

According to the statistics of Firestone Creation Database, there are more than 2400 enterprises with pharmaceutical raw materials production qualification in China. According to the regional distribution of enterprises, the largest distribution of pharmaceutical raw materials enterprises is in Jiangsu and Zhejiang, with more than 300 enterprises, followed by Shandong, Sichuan and Hubei. At present, a national chemical raw material medicine base in Zhejiang Province has been established in Linhai, Zhejiang Province, which is the earliest and largest concentration area of chemical raw material medicine and pharmaceutical intermediates industry in China. In addition, with the increasing pressure of environmental protection, nearly 100 pharmaceutical enterprises in Beijing have "piled up" in Bohai Bay, and the API base in northern China has taken shape.

Nowadays, China is not only the world's largest producer of APIs and exporter of APIs, but also an obvious industrial concentration. According to the Report of Raw Material Drug Species and Market Analysis published by Pharmaceutical Network in 2017, the producers of raw material drugs and related intermediates are mainly concentrated in areas with traditionally developed chemical industry, represented by Zhejiang, Shandong and Hebei. In the TOP50 list of API exporting enterprises in 2017, the regional agglomeration of dominant enterprises is still obvious, such as Huahai and Puluo in Zhejiang, Shijiao Group in Hebei, Xinhua Pharmaceutical and New Pharmaceutical Industry in Shandong Province.

Development Trend and Opportunity of China's API Industry

2.1 Under the strict supervision of environmental protection, the API industry will continue to optimize its product mix, upgrade its industry and transform into a high-end API industry.

Policies on environmental protection have accelerated in recent years. In 2012, the State Council issued the Water Pollution Prevention and Control Plan for Key Valleys, which calls for greater restructuring of pharmaceutical and other enterprises and the closure of "low, small and scattered" enterprises with high pollution and energy consumption. In some areas, the chemical oxygen demand (COD) and ammonia nitrogen (NH3-N) emissions from pharmaceutical enterprises have been limited. After that, the supervision of water, atmosphere and soil was gradually strengthened. In July 2014, "Detailed Rules for the Implementation of the Assessment Measures for the Implementation of the Action Plan for the Prevention and Control of Atmospheric Pollution" was promulgated, requiring that capacity expansion be restricted and backward capacity be eliminated.

In January 2015, the new environmental protection law was promulgated, and mandatory measures such as administrative detention, seizure and detention were added to the punishment. In addition, the system of permit management was adopted for sewage discharge, and no sewage discharge was allowed without a sewage discharge permit. In April, ten key industries of water came in succession, and the manufacture of APIs was listed as one of the top ten key industries, which needed to be cleaned up and rebuilt. Ten key industry construction projects were newly built, rebuilt and expanded, with the replacement of major pollutants discharged in equal or reduced quantities. Pharmaceutical (antibiotics, vitamins) industries implemented green enzymatic production technology transformation. At the same time, the industrial sewage is classified by the ten water articles, and the sewage discharge of raw material pharmaceutical enterprises is limited.

In 2016, the Environmental Protection Tax Law was promulgated. This time, the environmental protection fee was changed into the environmental protection tax. At the same time, enterprises with less emissions were given tax relief. The Environmental Protection Tax Law has increased the level of tax reduction and exemption for taxpayers'emission reduction, that is, if the concentration value of taxable air pollutants or water pollutants discharged by taxpayers is less than 30% of the prescribed standard, the environmental protection tax shall be levied at 75%. In the 13th Five-Year Plan for Environmental Protection, the API manufacturing industry is required to promote the transformation of industry emission standards.

In 2017, the Ministry of Environmental Protection issued the Work Programme for the Prevention and Control of Atmospheric Pollution in Beijing, Tianjin, Hebei and the Surrounding Areas in 2017 (Draft for Opinions). It requires pharmaceutical and pesticide enterprises to stop production in winter heating season. The implementation scope includes Tianjin, Beijing, Shijiazhuang, Jinan, Zhengzhou, Taiyuan and other cities.

The increasing pressure of environmental protection has also increased the environmental expenditure of pharmaceutical manufacturing enterprises, which forced some small production capacity to withdraw from the market, increased the concentration of the industry, and brought certain opportunities for pharmaceutical raw materials manufacturing enterprises. At the same time, experts said that APIs enterprises need to increase investment in environmental protection, upgrade their industries, improve their processes and enhance their capacity to deal with pollution, so as to achieve sustainable development in future development and seize structural opportunities.

2.2 The concentration of API industry will be further enhanced with the advent of DMF system for APIs.

The Regulations on the Joint Examination and Approval of APIs, Pharmaceutical Supplementaries and Pharmaceutical Packages (Draft for Consultation) issued by the State Administration of Food and Drug Administration (SAFDA) will no longer accept the application for registration of APIs, Pharmaceutical Supplementaries and Pharmaceutical Packages separately from the date of publication of the announcement.

The Registration Platform and database of APIs, pharmaceutical excipients and pharmaceutical packages will be established by the Drug Examination Center, which means that the domestic DMF system of APIs will be implemented step by step. DMF is the main management mode of APIs in developed countries in Europe and America. Under the DMF system, APIs enterprises can submit DMF files to the regulatory authorities at any time, but the regulatory authorities will not review the DMF technology. Only when the DMF is used in the registration of the APIs, the regulatory authorities will associate the APIs with the APIs. Conduct a joint review.

This means that in the future, the drug attributes of APIs will be lost, and the monopoly rights of some APIs will also be lost. Pharmaceutical preparation enterprises will become the main responsible persons for drugs. Pharmaceutical preparation enterprises will be responsible for the quality of raw and auxiliary drugs. Therefore, they will be more cautious in the selection of raw and auxiliary materials, and some raw and auxiliary materials enterprises whose quality is not guaranteed will be lost. It will be phased out and the industry concentration will be further improved.

2.3 Under the new pharmaceutical policy environment, with the improvement of R&D strength in China, the number of approved innovative drugs blowout, which further strengthens the demand and speed of the industrialization of APIs in China.

The problems of slow drug review, excessive backlog and difficult approval have been a major dilemma faced by many pharmaceutical enterprises, seriously affecting their R&D efficiency and industrialization progress. Since 2015, the domestic pharmaceutical policy has undergone a subversive reform. The State Pharmaceutical Regulatory Bureau has promulgated a series of policies and regulations, including priority review, special review, simplified approval procedures, and so on, which has promoted the process of pharmaceutical industrialization in China.

Encouraged by a series of new drug R&D policies, China's innovative drug R&D capability has been greatly improved. Prior to this, most of the pharmaceutical enterprises in China were generic drugs, but few of them really owned innovative drugs. According to statistics, in the 10 years from 2008 to 2017, there were 13 small molecule chemical drugs of "China 1" approved by CFDA, which were independently developed by local enterprises. In 2018, there were 10 varieties of new drugs of "China 1" in China. It has been approved to be listed in China. According to the report of "New Drug Review Summary 2013-2018", the trend of new drug application from 2013 to 2018 shows that the number of new drug applications has increased year by year in recent years. In 2018, 225 varieties of domestic new drugs have been declared, which is the highest in 10 years. With the acceleration of the review and approval, the number of approved innovative drugs in China is approaching. The year of blowout.

Information on APIs:

Although APIs are only raw materials and cannot be directly given to the human body, they are indispensable and indispensable as effective active ingredients. In the past, when there was a shortage of doctors and medicines, as long as the raw material drugs could be produced, the status of the raw material drugs could be seen. With the vigorous development of API market, most kinds of APIs can meet the domestic pharmaceutical demand, and continuously expand production capacity to sell abroad, which gradually established the position of APIs in the global pharmaceutical supply chain.

1. Three Crimes in the Domestic API Market

The development of generic drug market in China also benefits from the full competition of API market. There are many API manufacturers to choose from, which is a popular phenomenon for pharmaceutical manufacturers. However, with the passage of time, pharmaceutical factories are finding it difficult to procure APIs in China, the world's largest producer of APIs. Especially in the past three or five years, all kinds of negative news began to fill the domestic raw material drug market.

The first is the supply problem, which is mainly manifested in factory closure, shutdown, out-of-stock and out-of-stock. In recent years, the state has paid more and more attention to environmental protection and safety, and the punishment is also increasing. For the production operations which are prone to "three wastes" and flammable and explosive, the supervision is constantly strengthened. Enterprises are facing shutdown and transformation or upgrading, which directly results in shutdown and rectification, and subsequent production costs rise and pass on to customers.

Second, prices have risen sharply. In addition to the reasons just mentioned that production costs have increased due to environmental protection and safety problems, the more abhorrent phenomenon is the malicious rise caused by monopoly. Monopoly can also be divided into several situations: first, competitors stop production one after another for various reasons, resulting in only a few or even only one supply in the market, thus forming a natural monopoly; second, several factories that can normally produce in the market have reached written or oral agreements in terms of price, profit, quantity and region. Third, a dealer or a distribution alliance buys out the distribution right from all factories, thus gaining the absolute voice of a certain kind of sales.

In recent years, Chlorphenamine maleate, glacial acetic acid, lidocaine, calcium gluconate, digoxin, phenol, urea, camphor, meglumine and other raw materials have increased in different ranges in a short period of time, and the increase ranges from several times to dozens of times. The pharmaceutical products of these APIs belong to the classical veteran drugs. They are small profits and quick sales. They form a routine in the prescription of doctors and the daily use of drugs by the common people. The price of raw material drugs has risen sharply, seriously squeezing the profit or even losing money of pharmaceutical factories. Once pharmaceutical factories increase the price of finished products, there will be a huge contradiction between manufacturers and patients. As a result, many pharmaceutical factories simply choose to give up production. News of people complaining that they can't buy commonly used medicines on the market is frequently seen in the media, and news that successful medical insurance companies around the world have abandoned supply due to cost reasons is also endless.

Another point is the quality problem. With the advancement of consistency evaluation of quality and efficacy of generic drugs and the stricter scale of approval of newly declared generic drugs, the quality control of APIs needs to be compared with the strictest standards in Pharmacopoeia of different countries. Additionally, the requirement of dissolution and impurities in generic pharmaceuticals raises higher requirements for particle size and impurities of APIs, especially for genotoxic impurities. In the past, pharmaceutical manufacturers would not inform pharmaceutical manufacturers of changes in the source of starting materials or process routes, and pharmaceutical manufacturers would not make such special requests to pharmaceutical manufacturers. Everyone knows that changes in the production process of APIs will have a direct impact on the quality of preparations, especially changes in impurity mass spectrometry. If the change information of API production process can not be notified to the pharmaceutical manufacturers in time, the impact will make the pharmaceutical manufacturers very passive. Therefore, the integrity and cooperation of API manufacturers are very important.

See here is not to feel that the purchase of APIs is really worrying, if you can produce APIs.

In truth. If we look at the winning list of "4 + 7" purchasing with quantity published a month ago, the pharmaceutical preparations produced by APIs can win. There are 25 varieties in total. Among them, up to 20 varieties of APIs can be produced by our factory, subsidiary company, group or affiliated company. Only 5 varieties of APIs are purchased from abroad. The combination of APIs and preparations ensures fine cost control. The advantages of this purchasing with quantity are evident, which greatly reduces the risks of supply, price and quality, and naturally outperforms them.

For API purchased varieties, even if they are lucky to win the bid, the latter supply will make the enterprise tread on thin ice. Recently, the media reported the embarrassing situation of Beijing New Pharmaceutical Industry. After careful calculation, amlodipine besylate tablets were slightly profitable at the winning bid price. Suddenly, however, the price of APIs rose by 70%. Beijing New Pharmaceutical Industry must guarantee the supply of preparations according to the winning bid price. At present, this situation has to smash teeth and swallow in the stomach. How much profit can be left? I believe everyone knows it. It can be said that the pharmaceutical manufacturers are busy for a year, taking risks, but in the end they are working for the suppliers of APIs. As the current valid approval of amlodipine besylate not only originally developed by Pfizer, but also from China, India and Spain, it is not known which supplier Beijing New Pharmaceutical Industry refers to. This incident is a very timely warning for pharmaceutical manufacturers purchasing APIs. As a response measure, we must do a good job of increasing suppliers as soon as possible. The workload of pharmaceutical manufacturers is similar whether they have registered APIs or APIs requiring related reviews, but the risk of choosing the latter increases and they need to wait for the review and approval of APIs themselves by the pharmaceutical regulatory authorities. However, this is also a necessary work to ensure the normal supply of production capacity.

In order to break the market position of API sellers, more API manufacturers must be brought in to break the existing market order and re-shuffle their cards. As far as the current situation is concerned, domestic manufacturers are busy with the rectification of environmental protection and safety measures. From the perspective of economic interests, it is difficult for the latter to compete with the predecessors of rivers and lakes who firmly occupy the dominant position in the market of classical old drug raw materials, and the cost is difficult to achieve competitiveness in a short time. Therefore, API manufacturers prefer to make CMOs for innovative drugs or develop new drugs that are about to expire their patents. Therefore, for pharmaceutical manufacturers unable to produce their own APIs, they should not only rely on domestic supply channels, but also have an eye to the world.

2. The world is so big. Go out and have a look.

As the registration system of APIs has been formally implemented in China since December 2017, the original registration system of APIs has departed from the historical stage, so the valid approval documents in APIs Registry will disappear one after another, and APIs Registry will expand rapidly. At present, searching for APIs needs to take account of both the registry and the registry.

The following table is a summary of import registration certificates and API registration information sources as of December 31, 2018. Note that different packaging specifications of the same API from the same manufacturer are individual approvals or applications. Among them, 346 valid approvals for imported APIs cover 30 countries and regions according to the country of origin, while 586 import applications in the registry cover 33 countries and regions according to the country of origin, and other categories of countries of origin cannot be identified by public information.

We can get some useful information from the table. The "domestic approval" in the registry is far more than the "domestic application" in the registry, which not only indicates that a large number of "domestic approval" are sleeping, but also indicates that the domestic raw material drug GMP plant is shrinking dramatically. On the other hand, the import application in the registry has exceeded the import approval in the registry, except for one reason. Some multinational enterprises need imported APIs for realty of pharmaceutical preparations, and some expired products of registration certificates have been transferred to the registry to submit information (involving 56 items), more because imported APIs make up for the shortcomings of domestic production.

In addition, if more than 10 applications are approved, the main source countries of imported APIs to China are Japan, Korea, India, Europe and Taiwan. Especially Indian enterprises, which account for 40% of all import applications in the registry, have become the main source of imported APIs in China. However, it is necessary for Chinese people to reflect that the intermediates and crude products in the production of APIs in India are mostly imported from China and processed before being sold to the mainstream markets of the world, including China. But we all know the difference in value.

3. Import of APIs also has three offences

Let's go back and see if imported APIs are more advantageous than domestic APIs.

The first is supply. Since it is imported from abroad, considering factors such as transportation and customs, generally speaking, it has psychological expectations and tolerance for the supply cycle, and will do a better job in production and procurement planning. What we need to worry about may be that people in some countries take strikes as their hobbies, that domestic competitors initiate anti-dumping investigations, that customs clearance procedures are problematic, and that foreign factories arrange their own stop-production and rectification notices are not timely, and so on. In short, there seems to be no special advantage in the supply of imported APIs, but since the source of importation is chosen, it must be intolerable for domestic APIs in other aspects besides supply. Naturally, the supply risks of imported APIs are well anticipated and coped with.

The second is price. Generally speaking, imports are more expensive, but they cannot be generalized. The Ministry of Commerce decided to impose an anti-dumping duty on imported sulfamethoxazole originating in India. Until last year, the domestic industry of sulfamethoxazole did not submit an application for final review. The Ministry of Commerce also decided not to initiate a final review investigation on its own initiative. Since June 16, 2018, the Ministry of Commerce has imposed an anti-dumping duty on imported sulfamethoxazole originating in India. The anti-dumping measures applicable to imported sulfamethoxazole shall be terminated. This shows that the price of some APIs is much cheaper than that of domestic APIs, and the great price difference requires the intervention of the state. Of course, because of the cost of international trade, such as transportation, customs clearance and exchange rate, the price of imported APIs will also be expected. Conversely, in order to make a difference in the Chinese market, the importer must also give a reasonable price that meets the market expectations. In addition to imposing anti-dumping duties, tariff reductions and exemptions are also available to regulate the prices of imported products. In order to help reduce the burden of medication, the import tax rate of 52 anti-cancer, 4 rare diseases and 4 conventional medicinal materials has been reduced to 0 in recent days, which promotes the direct competition between imported raw materials and domestic raw materials. Of course, because of the cost of international trade such as transportation, customs clearance and exchange rate, the price of imported APIs has psychological expectations. Conversely, in order to make a difference in the Chinese market, importers must also give reasonable prices that meet market expectations.

Let's talk about quality. It's a common mindset that things bought from abroad should be better in quality. Now you are looking for imported APIs, and you will also tend to have American DMF or European CEP qualifications, so that you can be more comfortable. As a key material, APIs should be audited annually according to the general operating standards. However, long-distance travel abroad is always a time-consuming and laborious work. However, due to the limitation of manpower and budget, on-site inspection of foreign factories is very rare (see: CFDA Bright Sword! On-site inspection and analysis of overseas production of imported drugs. According to the on-site inspection of imported drugs from 2014 to 2018, only 16 of the 160 tasks involved APIs (11 APIs and 5 APIs + preparations). Four of them were ordered to stop importing because of serious violation of China's GMP regulations. The proportion was not low and all of them came from India. This is not to say that the quality of raw materials in India is poor, but that the forests are big and there are all kinds of birds. However, as long as corrective measures are in place, imports can be restored. However, this can serve as a warning.

In addition to GMP conformity of foreign factories, there is also one point that is the conformity of Pharmacopoeia standards. Recently, the dissolution of Amoxicillin Capsules in consistency evaluation is a typical case. The same API also has various differences in national pharmacopoeia standards, such as whether to test items or limit differences. Since foreign manufacturers supply APIs globally, it is difficult to meet the specific requirements of the Chinese Pharmacopoeia. Sometimes manufacturers can adjust the testing methods to meet the requirements, sometimes some standards are contradictory and can not be taken into account. Of course, the current domestic review requirements are in line with the Chinese Pharmacopoeia, on the basis of comparison with the world's major national pharmacopoeia, the most stringent test items. Meet specific varieties, will have their own troubles.

4. Is there any fun in the API market?

With the "4 + 7" purchasing with quantity unveiled a month ago, the policy dividend expected by the consistency evaluation of enterprise's hard work from top to bottom is like a lottery lottery lottery lottery - an empty joy. The whole generic drug market is going down in an instant. The winning bidding price can be said to take off the underpants. Every cost of the preparation should be carefully calculated. The effort of "picking, pinching and breaking" must be in place. As one of the most critical costs, the status of raw materials and drugs is more prominent.

As mentioned above, 20 of the 25 products that won the bid are made from raw materials. It's hard to get such a low price if the API is stuck in the neck. In addition, the winning enterprises are basically large-scale pharmaceutical factories, that is, sufficient capacity, large batches in order to share management costs and other production costs as much as possible. For example, the cost of testing, the same 1 million pieces, if it is a batch of production, that is, testing once, and if it is a batch of 500,000 pieces, that is to test twice, the other series of costs can be imagined. It seems that the generic drug market can only survive in large pharmaceutical factories, which also produce their own raw materials. So, how about the API market?

In fact, not all medicines are suitable for purchasing in quantity. They must be those with large dosage, wide coverage and more important.

Special varieties with technical barriers. Starting materials are obtained by fermentation of some special strains, or cost advantages are brought about by enzymatic greatly increasing yield, as well as some varieties with harsh synthetic reaction conditions, and some high-activity products, etc. Through technical means, natural threshold is formed, with less competition, and naturally many enterprises will not meet the requirements. Situation. For example, Bori Pharmaceutical focuses on high-end APIs with few competitors and great technical difficulties, and takes the integration of raw materials and preparations, which has become the darling of the capital market.

The patent is about to expire. Speed up, seize the key period of generic drug development. Develop mature products as soon as possible, cooperate with customers to develop preparations, so as to seize the opportunity. In order to achieve imitation, sometimes customers are willing to outsource the raw materials of mature technology, so as to save time and concentrate on the production process of the preparation.

In addition to the need for more prudence in project formulation, with the implementation of API registration system, market strategies also need to be adjusted. In the past, the registration declaration of APIs could act independently. Customers could cooperate at home before approval, or purchase after approval. Now it's time to take the initiative. If there's no pharmaceutical manufacturer to cooperate to trigger the API related review, APIs will be waiting there even if they are registered. However, once the first preparation is approved for the market, the status of the results of co-examination and approval with the preparation becomes A (raw materials approved for use in the listed preparation), and the subsequent sales work is relatively easy. Therefore, it is very important to cooperate with the first preparation development declaration, whether it is generic drug preparation development or generic drug preparation to increase the suppliers of APIs.

5. High-quality products, reasonable prices and intimate services

When a pharmaceutical manufacturer chooses an API, it usually does not change, because the replacement is very troublesome, the workload is one aspect, and it also bears a lot of risks. Some API manufacturers just recognize this mentality and assume a high attitude, the cooperation between the two sides will be unpleasant, especially those sudden malicious price rises are even more disgraceful, until the end of the customer can only be grateful and determined to change suppliers.

In fact, the requirements of customers are not very high. All they need is full cooperation of quality audit, early notification of production adjustment and process change, reasonable price adjustment, timely and sufficient delivery. In summary, they are high-quality products, reasonable prices and intimate services. As long as these three points are achieved, customers can be firmly grasped in hand, and natural resources are rolling.