Market Size (2017)
$59.04B
Vertical: HealthcareBase Year: 2017
Market Size (2017)
$59.04B
Projected (2023)
$73.55B
CAGR (2015–2023)
3.3%
Key Players
10+
The duloxetine is type of antidepressant known as serotonin norepinephrine reuptake inhibitor used to treat depression and anxiety and also widely approved for the treatment of stress urinary incontinence in women and other chronic diseases. The atorvastatin is commonly used in lowering the cholesterol level and helps prevent cardiovascular diseases. Increasing aging patient population, the rising incidences of chronic diseases globally, and increasing disease awareness drive the growth of the global duloxetine intermediate and atorvastatin intermediates market. However, stringent regulatory policies may hamper the growth of the market.
The global duloxetine intermediate and atorvastatin intermediates market is expected to register a CAGR of 4.04% during the forecast period from 2018 to 2023. In 2017, the market was led by the Americas with 35.7% share, followed by Europe and Asia-Pacific with shares of 31.5% and 25.2% respectively.
The global duloxetine intermediate and atorvastatin intermediates market have been segmented based on intermediate type and region.
The Duloxetine Intermediate Atorvastatin Intermediates Market market is projected to grow at a CAGR of 3.3% from 2015 to 2023.
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View Subscription PlansDuloxetine Intermediate Atorvastatin Intermediates Market
Historical performance and future projections (2020–2030, USD Billion)
Market Size (USD Mn)
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) which is widely approved for the treatment of stress urinary incontinence in women, major depressive disorder (MDD), and other chronic diseases. It reduces painful physical symptoms in depressed patients. Hence these are also recommended in the treatment of diabetic peripheral neuropathic pain (DPNP). As there is a rising prevalence of the major depressive disorder among adults, the demand for duloxetine intermediate is increasing.
The atorvastatin is commonly used in lowering the cholesterol level and helps prevent cardiovascular diseases. Hence it helps to boost the growth of the global duloxetine intermediate and atorvastatin intermediates market.
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View Subscription PlansThis report applies a rigorous multi-stage research process combining primary interviews, secondary data sources, and bottom-up market modelling to ensure accuracy and completeness across all segments and geographies.
Base Year
2017
Historical Period
2015 – 2016
Forecast Period
2018 – 2023
Primary Interviews
150+
Historical data (2015–2017) and forecast period (2017–2023)
Our research process spans primary interviews with industry stakeholders combined with comprehensive secondary data analysis, validated through triangulation across multiple independent sources.
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View Subscription PlansThe global duloxetine intermediate and atorvastatin intermediates market is characterized by the presence of many global, regional, and local vendors. The market is extremely competitive with all the players contending to gain the maximum market share. Intense competition, rapid innovations in products, frequent changes in government policies, and environmental regulations are key factors that confront market growth. The vendors in the market compete based on cost, quality, and reliability. It is critical for vendors to provide cost-efficient and high-quality products, to survive and succeed in an extremely competitive and growing market environment.
The growth of market players is reliant on market conditions, government support, and industry development. Therefore, vendors should focus on expanding geographically and improving their products. They predominantly focus on the development of novel products. Global players are expected to strengthen their presence worldwide through acquisitions during the forecast period. It has also been forecast that improvement of the global economic scenario combined with efforts to enhance infrastructure in emerging nations, is fueling the market growth, thereby making it a perfect time for new products and to increase the market share.
Companies with better technical and financial resources could develop innovative products. Therefore, market players must develop new products and stay abreast of emerging technologies that could affect the continuing competitiveness of their product lines in the market.
The major players in the Global Duloxetine Intermediate and Atorvastatin Intermediates have well developed distribution networks globally. Additionally, they deal in both duloxetine intermediates and atorvastatin intermediates. Moreover, they are engaged in innovative strategies to enhance their position in the market. For instance, Fluorochem Ltd has started to sell its products on online platforms. Top players in the market are Tokyo Chemical Industry Co., Ltd, Fluorochem Ltd, Jigs Chemicals and Arch Pharmalabs.
Other major players include Afine Chemicals Ltd, Jiangxi Aifeimu Technology Co.,Ltd and MANUS AKTTEVA.
Threat of New Entrants
The threat of new entrants in the global duloxetine intermediate and atorvastatin intermediates market is moderate to high. A profitable industry will attract more competitors looking to achieve profits. As the number of entrants increases, the profitability of the present players in the industry subsequently decreases. The market has a high threat of new entrants, threatening the existing players. Moreover, the cost involved in R&D is comparatively high which does not comfort the new entrants to enter the market easily.
Bargaining Power of Suppliers
Bargaining power of suppliers in the global duloxetine intermediate and atorvastatin intermediates market is medium. The suppliers in the global duloxetine intermediate & atorvastatin intermediates industry are the manufacturers of chemical compounds of duloxetine and atorvastatin. Currently, a moderate number of suppliers are present in the market due to stringent government regulations and high opportunities. Currently, major players are accounting for a significant share of the market. Switching cost of the suppliers is medium because suppliers tend to enter into long-term associations, partnership, and deals with the companies that sell duloxetine intermediate & atorvastatin intermediates.
Threat of Substitutes
The threat of substitutes in the global duloxetine intermediate and atorvastatin intermediates market is high. Currently, duloxetine intermediate & atorvastatin intermediates have many direct substitutes. For instance, duloxetine has substitutes like venlafaxine, citalopram, fluvoxamine, etc. Also, atorvastatin has substitutes like lovastatin, rosuvastatin, simvastatin, etc. Hence, the threat of substitutes is high in the duloxetine intermediate and atorvastatin intermediates market, due to the availability of many options in the market.
Bargaining Power of Buyers
Buyers of duloxetine intermediate and atorvastatin intermediates are the manufacturers of duloxetine and atorvastatin APIs. The bargaining power of the buyers is medium in the global duloxetine intermediate and atorvastatin intermediates market due to the presence of a moderate number of providers of duloxetine intermediate & atorvastatin intermediates. Also, buyers prefer products manufactured by known brands. However, there are many big brands present in the market. Because of this, the bargaining power of the buyers is medium.
Intense Rivalry
The degree of competition in the global duloxetine intermediate and atorvastatin intermediates market is high. Many companies are present in this market. These players have a moderate degree of product differentiation. They are introducing innovative and more affordable products in the market. These factors increase the rivalry in the duloxetine intermediate and atorvastatin intermediates market. Companies involved in the market are trying to acquire new players in the market and merge with major players to survive in the market. Big brands are trying to acquire small players of the market, to create a competitive edge, which is creating a high level of rivalry in the market.
Market estimates by geography (2023)
InsightEurope leads with $23.28B by 2023, while Asia Pacific is projected to grow fastest at a 4.2% CAGR.
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View Subscription Plans| REGION | 2015 | 2017 | 2023 | CAGR | SHARE |
|---|---|---|---|---|---|
| Middle East and Africa | $4.30B | $4.74B | $5.62B | 3.4% | 8% |
| North America | $17.78B | $19.22B | $22.24B | 2.8% | 30% |
| Asia Pacific | $14.02B | $15.95B | $19.46B | 4.2% | 26% |
| Europe | $17.75B | $19.63B | $23.28B | 3.4% | 32% |
| South America | $2.68B | $2.73B | $2.95B | 1.2% | 4% |
| Total | $56.53B | $62.27B | $73.55B | 3.3% | 100% |
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Analytical insights on Duloxetine Intermediate Atorvastatin Intermediates Market covering market dynamics, competitive landscape, and strategic outlook.
The Duloxetine Intermediate Atorvastatin Intermediates Market market is projected to reach $73.55B by 2023, growing at 3.3% CAGR.
Duloxetine is an orally administered antidepressant drug that is used for the treatment of the major depressive disorder (MDD). The pre-clinical trials of duloxetine have proved that it is significantly more efficacious in the treatment of major depressive disorders. It is the most widely preferred drug for the treatment of MDD and drug interaction with the body is less as compared to other serotonin reuptake inhibitors (SNRI). It is also used in the treatment of multiple sclerosis, chronic pain conditions, and in painful diabetic neuropathy. As per a survey carried out by the US National Library of Medicines in 2015, around 3,50,000 to 4,00,000 Americans had multiple sclerosis, and duloxetine intermediates were used for the treatment. Duloxetine was first approved in 2004 for the treatment of various chronic disorders such as major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain. It was also used for the treatment of GAD in pediatric patients aged 7 to 17 years.
Atorvastatin is used to lower the bad cholesterol and fats and helps to raise good cholesterol in the blood. It is a salable cholesterol-lowering drug with worldwide annual sales exceeding 10 billion dollars in 2017. Multiple prospective studies have shown the cardioprotective and antioxidant effects of atorvastatin intermediates which had been used widely from many decades. LDL-cholesterol levels remain the principal target for lipid modification and hence the atorvastatin therapy is most widely used to lower the cholesterol level. Atorvastatin therapy is associated with a significant reduction in cardiovascular endpoints. However, concerns have been raised over the use of atorvastatin and an increased risk of diabetes.
Depression is a mood disorder that causes loss of interest and a persistent feeling of sadness. It is also known as major depressive disorder. It leads to various emotional and physical problems. It is a major public health problem worldwide and a leading cause of disability as well as mortality along with socioeconomic problems. It affects a large number of people including both men and women. Globally major depressive disorder (MDD) is the most prevalent mental disorder. As per a survey carried out by the National Institute of Mental Health in 2016, 16.2 million adults in the US had at least one major depressive disorder. The prevalence was found higher among adult females that are 8.5% as compared to males that are 4.8%. A major depressive disorder is one of the leading causes of disability worldwide and is a major contributor to the overall global burden of diseases in low- and middle-income countries. As per the Global Health Estimate Report 2015, the global proportion of the population with depression was estimated to be 4.4%. It is more common in females of the 55 to 74 year age group. Hence, the prevalence of depression is growing every year.
Developing economies pose an opportunity for various markets as they have undeveloped research and development sectors owing to which they are unable to address upcoming health challenges. Despite huge demand, the African region is dependent on imported medicines and other health technologies. Although there is a high requirement for treatment, poor economic conditions lead to the slow growth of the healthcare industry within the African region. As per the statistics report of the World Health Organization (WHO) 2017, around 80% of the population affected with chronic disease lived in low- and middle-income countries. This huge population affected with the chronic disease in developing countries serves as a strong opportunity for key players operating in the global duloxetine intermediate and atorvastatin intermediates market. The increasing prevalence of various chronic diseases has served a good platform for manufacturers. Many types of active pharmaceutical ingredients are available in the market. However, many of them have different side-effects, and thus, there are a number of opportunities for manufacturers to develop new drugs. Many drugs are not prescribed to patients suffering from hypernatremia and other chronic diseases. Besides this, there are huge opportunities for the development of the market in developing countries.
In 2017 the US health care cost was USD 3.5 trillion. Hence the US is one of the leading countries in the healthcare sector. The rise in healthcare cost can be observed due to the increasing prevalence of chronic diseases such as diabetes and heart diseases. These are responsible for 85% of the total healthcare costs. Almost half of the American population is suffering from either one of the chronic diseases. As there is a growing prevalence of chronic diseases the demand for atorvastatin intermediate is also increasing. The second cause of rising health care cost is widespread in preventable diseases. The leading causes of death are due to heart disease, cancer, chronic obstructive pulmonary disorder, and stroke. These diseases can be prevented if diagnosed at an early stage. Smoking is an important cause of lung cancer and chronic obstructive pulmonary disease (COPD). These diseases cost around USD 7,900 per person which is five times more than the health care cost for a healthy person. The average cost of treating diabetes is USD 26,971 per family. These diseases are difficult to manage because patients get tired of taking numerous medications.
In terms of market access, the increasing cost of healthcare is due to the increasing demand for new intermediates used in the healthcare industry. Scientists have been exploring numerous ways to come with innovative drug intermediates to prevent outbreaks. The success of biological drugs reflects the ability to treat major chronic diseases mostly cancer and autoimmune diseases. Biopharma launches are being particularly facilitated by the FDA. The 21st Century Cures Act, signed by the former President of America, Obama on December 13, 2016, has helped speed up drug development in general, but biologics are more preferred because of their more common applicability to unmet needs. As there is an increasing demand for intermediates worldwide, scientists have explored numerous ways to innovate new drug intermediates. This introduction of new synthesis methods discloses the preparation method for atorvastatin intermediates. As per one of the research papers, a new method was developed to carry out the synthesis of atorvastatin intermediates. This method comprises the following steps:
The first step is reacting (R)-epichlorohydrin and nitromethane to generate 1-chlorine-4-nitryl-(R)-2-butanol and further reacting it with sodium cyanide to obtain (R)-3-hydroxyl-5-nitryl-valeronitrile. The second step is adding the obtained product into a tert-butyl bromoacetate zinc reagent to generate 7-nitryl-5-hydroxyl-3-carbonyl-heptylic acid tert-butyl acetate.
Further, it is treated with sodium borohydride to generate 7-nitryl-3,5-dihydroxyl-heptylic acid tert-butyl acetate. In the third step, the above product is reacted with 2,2-dimethoxypropane, acetone, and methanesulfonic acid to obtain 7-nitryl-3,5-O-isopropylidene-3,5-dihydroxyl-heptylic acid tert-butyl acetate and (3R, 5R)-7-amino-3,5-O-isopropylidene-3,5-dihydroxyl heptylic acid tert-butyl acetate by hydrogen reduction. The yield of the product is 80% to 86%, and the purity of the product is greater than or equal to 99.0%.
One more method was developed for the synthesis of atorvastatin intermediates in 2015 by a scientist, named Codexis. Codexis had developed a green-by-design three enzyme process for the synthesis of atorvastatin intermediates
Pricing is among the most important factors for any product to withstand in the market. Pricing of any product or service depends on many factors which include the cost of raw materials used for the product, technology, cost of research and development, labor charges, and many other costs. Pricing plays an important role in the business to make key strategies. The duloxetine intermediate and atorvastatin intermediates market is a narrow range market. The cost of the product varies by region and application.
Duloxetine intermediate and atorvastatin intermediates are used in pharmaceutical companies to manufacture APIs. The companies are focused on the use of specific technologies, to reduce the cost of the product. These products vary by applications and the region in which they are sold. Also, the brand of the product determines its price. So, major companies are focusing on developing cost-effective products to grow their business in developing regions such as Asia-Pacific and the Middle East.
Duloxetine is the selective norepinephrine and serotonin reuptake inhibitor (SNRI) class of antidepressants that have been approved for the treatment of the major depressive disorder (MDD). The drug faces quality issues due to foreign contaminants leading to quality issues. The drug needs to comply with the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP) standards and various regulatory bodies across the world such as the Food and Drug Administration (FDA), European Chemicals Agency (ECHA), South African Health Products Regulatory Authority (SAHPRA), and Drug Controller General of India (DCGI). Duloxetine Intermediate had 1.4 million bottle recall because when the product was tested for stability, it failed the dissolution specification test.
The atorvastatin intermediate drug leads to decreased levels of low-density lipoprotein (LDL) cholesterol. Lipitor was the first drug to reach the annual sales of 10 billion dollars in the US and currently is the top-selling pharmaceutical product globally. Atorvastatin intermediate had 2,280 bottle recalls from the market in 2016 because it causes adverse health consequences.
Quality control issues of the drug can be alarming for the public and may cause severe health issues. For instance, in December 2017, the US FDA announced class II recall on Lupin of 1.11 lakh units of duloxetine intermediate.
The FDA also reported another recall of more than 1.4 million bottles of the antidepressant manufactured by Apotex in Canada. For instance, in July 2016, Apotex Inc failed the impurity testing process, which resulted in a recall of 1.4 million bottles of atorvastatin intermediate. Also, the company received a warning from the FDA, whereas Dr. Reddy's Laboratories Limited has recalled Atorvastatin intermediate tablets from the US market after noticing certain anomalies in the out of specifications (OOS) investigations. The company initiated a voluntary recall of 2,280 bottles of atorvastatin intermediate tablets in August 2017, as per the US Food and Drug Administration (USFDA).
In Europe, atorvastatin production is hindered owing to the ECHA regulations for its severe side-effects such as myopathy and liver problems, among others. The product strictly needs to follow the EP and FDA standards to avoid serious quality issues. For instance, in November 2012, Ranbaxy Pharmaceuticals Inc recalled more than 40 lots of atorvastatin intermediate due to glass contamination.
Lupin and Cadila healthcare faced a recall for the duloxetine intermediate with 19,812 bottles in 2017 by the FDA. These drugs were recalled due to the presence of a foreign substance. The presence of unwanted foreign substances even in a low amount may influence the efficacy and safety of pharmaceutical products.
In addition, India-based generic drug maker Ranbaxy Laboratories has issued a recall of generic version of the atorvastatin intermediate. The company recalled more than 64,000 bottles of atorvastatin intermediate because some bottle may contain a high dose of the drug than the normal standard limit.
Generic drugs are copies of brand-name drugs that have the same dosage and effects as the original drug. All generics must be approved by different regulatory organizations and pharmaceutical standards. In South Africa, the South African Health Products Regulatory Authority (SAHPRA) controls the sale of impure generic atorvastatin owing to the increased risk of people suffering from chronic disorder.
Investment in the market highlights the growth parameters of the industry. Patents and approvals, reimbursement policies, the growth of duloxetine intermediate and atorvastatin intermediates, and the complications caused due to various factors define the potential of the market. There is a huge demand for duloxetine and atorvastatin intermediates in the market.
Innovation and development in the duloxetine intermediate and atorvastatin intermediates market benefit both manufacturers as well as investors, to make huge profits. Therefore, a revolution in technologies for new products offering will provide investment opportunities in the future.
Investing in Research and Development to Overcome the Side-Effects
Duloxetine has side-effects such as insomnia, diarrhea, constipation, low energy, and drowsiness, among others. Side-effects of atorvastatin include drowsiness, fever, memory problems, rhabdomyolysis, etc. Companies can invest in research and development to manufacture duloxetine and atorvastatin intermediates which have no or very few side-effects. This discovery can help market players to create a competitive edge in the market.
Entering Untapped Markets
Duloxetine and atorvastatin have many substitutes. These substitutes are available in many countries worldwide. Major players in the market can invest in entering untapped regions of these substitutes such as African countries or other developing countries.
There are various existing players manufacturing duloxetine intermediate and atorvastatin intermediates for various indications. The companies can outsource the manufacturing of products. So, this may reduce the cost of manufacturing.
Near-term growth will likely concentrate in modular bioreactor lines and closed-system media workflows that shorten validation cycles while preserving batch traceability.
Partnerships between CDMOs and instrumentation vendors should accelerate standard datasets for comparability across sites, improving forecasting models used in capacity planning.
Longer horizon, organoid and microphysiological adoption may reshape segment mix; teams that invest early in assay interoperability and cloud QC hooks are better positioned to capture upside without fragmenting their analytics stack.
Profiles of 107 companies operating in the Duloxetine Intermediate Atorvastatin Intermediates Market market, including revenue, employee count, and market positioning where available.
Showing 107 of 107 companies
Fluorochem Ltd
Company Headquarters: United Kingdom Founded: 1999 Workforce: 50+ Company Working: Fluorochem Ltd has been supplying intermediates for research and development to pharmaceutical companies, universities, biotechnology companies, and contract research organizations for over 40 years. The product portfolio of nearly 100,000 items includes organic research intermediates, fluorinated products, heterocyclic, boronic acids, Sulphur compounds, novel organics, organometallics, silanes, siloxanes, biochemicals, NMR solvents, NMR tubes, silica gel for chromatography, and thin layer chromatography (TLC) plates. In 2010 the company completed a three-year project to move the whole company into a brand new, purpose designed facility in Hadfield. This has enabled it to streamline its processes, store the chemicals more effectively, and improve and enhance QC facilities. Furthermore, the company has got an opportunity to review its procedures fundamentally and amongst other improvements, it has developed its material safety data sheet (MSDS) and labeling software to comply with Globally Harmonized System (GHS)/ Classification, Labeling and Packaging (CLP) regulations, and created a new internal system for order handling and stock maintenance. It has nearly 20000 products in stock for immediate delivery, some in bulk quantities. Moreover, many of its products can be produced in multi-kg quantities at the company’s US sister company, Oakwood.
Shodhana Laboratories
Company Headquarters: India Founded: 2000 Workforce: 1,000+ Company Working: Shodhana Laboratories is a WHO GMP ISO 9001-2008 and ISO 14000:2004 certified company. It is considered to be one of the most dynamic active pharmaceutical ingredients and intermediates manufacturing companies. Its facility has been audited and approved by the Korea Food and Drug Administration (KFDA), Federal Committee for Protection from Sanitary Risks (COFEPRIS) (Mexico), and Therapeutic Goods Administration (TGA) (Australia). The company has the most technically advanced production facilities, and its entire manufacturing process is as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) & Current Good Manufacturing Practices (cGMP) guidelines. Shodhana Laboratories also has a world-class R&D lab manned by a dynamic team of highly qualified and experienced scientists
Arch Pharmalabs
Company Headquarters: India Founded: 1999 Workforce: 5,000+ Company Working: Arch Pharmalabs is a world-class provider of small molecule process chemistry, custom synthesis services, and full life-cycle API and drug intermediates manufacturer for the global pharmaceutical industry. It has generated revenues of USD 200 million. Its India-based offering is supported by 2,400 customer-centric employees, eleven certified facilities (including cGMP-compliant, US FDA- and EDQM-approved sites), and two state-of-the-art process technology centers. Arch Pharmalabs works tirelessly to deliver value, innovation, and effective supply chain solutions in the spirit of true partnership. Its large family of satisfied customers ranges from emerging or specialty companies to global majors, many of whom have designated Arch Pharmalabs as a preferred supplier or strategic partner. Arch Pharmalabs received CNBC TV Emerging India 2006 Award as the No.1 Small or Medium Company in the Pharmaceuticals and Chemicals category
Manus Aktteva
Company Headquarters: India Founded: 1997 Workforce: 10+ Company Working: Manus Aktteva is an ISO 9001:2008 certified organization. It is a well-informed, highly efficient, swiftly functioning competitive sourcing entity. It serves private, institutional, and corporate clients worldwide in the field of pharmaceuticals and nutraceuticals. It combines its contacts, expertise, and core competency with its operations to deliver superior pharmaceutical sourcing solutions to customers. It has its base in India and has been serving clients in more than 50 countries. It specializes in global sourcing in the field of pharmaceuticals and nutraceuticals, facilitation of new molecule research, documentation support, i.e., Chemistry, Manufacturing & Controls (CMC) data package, and scale up new intermediates, exports, and imports
Chiral Bio Sciences Ltd
Company Headquarters: India Founded: 2008 Company Working: Chiral Bio Sciences Ltd (Chiral) is one of the fastest growing companies in the area of synthetic technology and chiral compounds. The company harnesses a combination of extensive expertise and latest technology and offers quality products and solutions that are innovative and cost-effective, catering to the rigorous and wide-ranging requirements of customers in the industry. Chiral embodies the vision of a top-notch player in developing and commercializing products catering to a variety of therapeutic categories. It currently manufactures advanced drug intermediates for Anti Retro Virals, Anti-Hypertensive, Anti Diabetic, etc. Chiral presently has an R&D Center with attached pilot plant and two commercial production units, totaling 80 KL capacity. It follows and maintains good manufacturing practices. A state-of-the-art manufacturing unit consisting of two production blocks of 80 KL each, meets all the international regulatory requirements that have been set up. The R&D Center is also scaled up to high levels/standards
Afine Chemicals Ltd
Company Headquarters: China Founded: 2005 Company Working: Afine Chemicals Ltd (Afine) specializes in fine chemicals and pharmaceuticals. Its products have earned great popularity in world markets. Since 2005, the company had been rapidly growing to become a leading manufacturer and trader of APIs in China. Afine has set up two independent business divisions, namely, fine chemicals division and pharmaceutical division. Afine’s chemical department is involved in manufacturing and trading of a variety of high-quality optical brightener and textile auxiliary as well as dyestuff, pigments, and other fine chemicals. The company is one of the leading exporters of optical brightener in China. The pharmaceutical division is involved in manufacturing, contract R&D, marketing and distribution of active pharmaceutical ingredients, intermediates, and feed additives. In March 2009, the Hangzhou government awarded “Top 100 innovation-oriented export enterprises of Hangzhou in 2008” among more than 13,000 export enterprise of Hangzhou
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