It is applied to any process such as cosmetic emulsions and glues that require agitation, homogenization, pulverization, suspension and dissolution.As follows:Mix: syrup, shampoo, washing liquid, juice concentrate, yogurt, dessert, mixed dairy products, ink, enamel.Dispersion and mixing: methyl cellulose dissolution, colloidal dissolution, carbide dissolution, oil-water emulsification, pre-mixing, seasoning production, stabilizer dissolution, soot, salt, alumina, pesticide.Dispersion: suspension, pill coating, drug depolymerization, coating dispersion, lipstick, vegetable puree, mustard mixture, catalyst, matting agent, metal, pigment, modified asphalt, preparation and depolymerization of nanomaterials.Emulsification: drug lotion, ointment filling machine, cream, mask, cream, emulsified essence, oil-water emulsification, emulsified asphalt, resin emulsification, wax emulsification, water-based polyurethane emulsification, pesticide.Homogenization: drug lotion, ointment, cream, mask, cream, tissue homogenate, dairy homogenization, juice, printing ink, jam.How Does The Homogenizer Work?After the material is mixed in the water pot and the oil pan by heating and stirring, the vacuum pump is sucked into the emulsification pot, and the center is stirred by the center of the emulsifier. The PTFE scraper always greets the stirring pot body and sweeps the wall sticking material. The new material is continuously generated by the material to be taken, and then the blade and the rotary blade are cut, compressed, folded, stirred, mixed and flowed down to the Cosmetic cream homogenizer below the pot body, and the material is cut by high-speed rotation. During the process of strong shearing, impacting, turbulence, etc. between the wheel and the fixed cutting sleeve, the material is cut in the shearing seam and rapidly broken into particles of 200nm-2um. Because the emulsifier is in a vacuum state, the material is in The bubbles generated during the agitation are pumped away in time.In the manufacturing process of high-viscosity emulsions, especially creams, ointments, and emulsions, the most problematic is usually the large particle size of the dispersed phase and the mixing of air into the product during agitation. The excessive particle size causes the emulsion to be unstable. Lack of gloss; air in the product will make the product bubble, bacteria, easy to oxidize and the appearance is not smooth. For the two major problems, the ZJR series vacuum homogenizing emulsifier unit is complemented by the characteristics of homogeneous mixer, central blade stirring and scraping wall mixing, and combined into the best mixing method to achieve perfect mixing products. By vacuuming, the produced products are no longer mixed with air bubbles during the stirring process, thereby ensuring the production of high-quality products with luster, fineness and good ductility.
The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means. Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies.Professional API ManufacturersThe leading manufacturer of pharmaceutical API manufacturing machine today is TAPI. Specializing in range of API-related fields, TAPI works in areas such as chemical synthesis, fermentation, chromatography and plant extraction and now has the industry’s largest portfolio of over 300 API products. In 2011 alone they achieved third-party sales of around $750 million.Dr. Reddy’s is another leading manufacturer with 60 APIs for drug use, diagnostic kits and biotechnology products. Aurobindo and Cipla manufacture 200 APIs each, exporting their products to well over 200 countries worldwide. Other notable manufacturers are Jinzong Machinery, Sandoz-Lek-Biochemie, Ranbaxy, Matrix and Sun.API OutsourcingAPIs are commonly referred to as ‘bulk pharmaceuticals’ and are in fact usually made in places at quite a distance to where tablets, suspensions and liquids are manufactured. Today, the greatest concentrations of API manufacturers are located around Asia, specifically in India and China. This has led to more and more companies to outsource API manufacturing to such places, which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure – which on top of everything can also be complicated to install and maintain. RegulationsRegardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used. So those APIs manufactured in China or India for use in the United States must still be inspected and licensed by the FDA. Similarly, if the API is intended for use in Europe, they would need to meet regulations set by the European Medicines Agency. Regular inspection outside the country of use however can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns. As a result, countries such as India have gained their foothold in the global market and now have around 75 FDA-approved manufacturing facilities for API synthesis.Going GreenToday there are more and more calls for API manufacturers to go green – that is to say, to reduce the waste they produce. Every year, large pharmaceutical manufacturers can produce anywhere from 3000 to 5000 tons of hazardous waste each. If one were to ask any reputable API manufacturer how they would like to improve the process, they’d likely say to make the reactions faster, or to make them cheaper. Ironically the first steps in reducing waste from API synthesis would be to reduce the number of reactions required to produce a given molecule. Therefore though the goal may be different, the means turn out to be the same as fewer reactions mean less solvent to dispose of. Another step in going green is to find different solvents and catalysts that are not only more efficient, but are also better for the environment.To the FutureMajor API manufacturers such as Jinzong Machinery, Merck, AstraZeneca and GlaxoSmithKline are also moving away from multifunctional plants and instead opting for specific activities at specific sites. In this way, there are serious concerns as to how any centralized control could function as after all an API manufactured by one company, in one country, with the excipient manufactured in another by a different company, then packaged and distributed by another company altogether makes the route rather difficult to monitor or control.The current growth in new medical technologies is spurring the demand for APIs worldwide today especially with the increased importation of raw pharmaceutical ingredients from emerging markets. Countries such as India and China, which now supply over 40% of APIs used in the U.S. will double that figure to a whopping 80% in just the next 10 years.
We manufacture a wide range of APIs based on the appropriate control system which complies with the regulations of international GMP* such as ICH* guidelines. Production activities operate daily at our factory that is experienced in obtaining FDA* approval by paying special attention to a variety of points such as not only high quality but also productivity, costs, safety, environmental influence, etc.We achieve the consistent suppply of safe and secure APIs by implementing three principles based on “Chemical Quality” 1 high quality, 2 high added value and 3 flexible service. You will find details on our three principles below:*GMP: Good Manufacturing Practice*ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use*FDA: Food and Drug AdministrationAbout GMP for APIs1.High qualityDay-to-day production activities are conducted in accordance with various operating procedures managed by the quality department. In our plant, GMP conditions are in full compliance, for example, with the status of the equipment used and plumbing are indicated clearly for easy understanding. Based on our specialist knowledge cultivated from 30 years of our experience on the manufacturing floor, we continually work on improving and manufacturing world-leading high-quality products. We are proud to offer the world these products by utilising our strengths in the craftsmanship and expertise cultivated as a result of our long-standing experience. As we move forward, we proactively install new equipment and expand our plants to remain committed to supplying high-quality pharmaceutical API manufacturing machine.2.High added valueNot only do we manufacture high quality pharmaceutical products, we also supply our products with an excellent standard of service in order to give our clients a high level of added value. In the production department, in addition to fostering GMP, we continue and pass on to the next generation the manufacturing technology which is based on many years of experience and expertise. In the quality control department, we monitor the trend of product quality in full compliance with GMP requirements. In the sales department, we work on promoting a good working relationship and cooperation by offering a comprehensive service which meets the needs of our clients. In this way, each department assumes their own roles and work well together so that we can supply APIs with “Katsura Chemical Quality”, delivering products of the finest quality whilst at the same time providing an excellent standard of service worldwide.3.Flexible serviceOur pharmaceutical production line is able to deal with a wide range of products.We manufacture APIs as our major products. These also include APIs for investigational drugs as well as raw materials for cosmetics. Our production line is able to deal with a wide range of products that cover a manufacturing volume from small scale of a few hundred grams to a large scale of a few tons.Expert knowledge from a 30-year track record of long-standing experienceWe manufacture APIs by applying various chemical reactions such as organic synthesis using many different kinds of special reagents and catalysts. In addition, we are also able to manufacture high-quality APIs with a complex chemical structure by making full use of the purification technology of our own creation and many different types of manufacturing equipment.Our expertise from the wide range of experience and proven track record of business over the past 30 years enable us to provide a prompt and flexible service that meets the need of our clients
The role of active pharmaceutical ingredient (API) manufacturers in the pharmaceutical industry supply chain is evolving in response to newfound demands from customers and growing pressures from global competitors. Increasingly, innovators are looking beyond their usual group of closely-knit European suppliers. Meanwhile, traditional generic companies are looking to India and China for bulk actives, while specialty pharma companies have generated new demands for more specialized capabilities than those required by traditional generics. In order to remain competitive, API manufacturers will need to attune themselves to this evolving landscape.Historically, innovators have relied on a small number of suppliers with which they work confidentially. Innovators frequently opt to perform the final stages of API synthesis themselves, outsourcing (at most) the production of late stage intermediates. While this pattern continues to predominate, innovators have begun to look beyond their current European suppliers to realize benefits from partnerships with Indian and Chinese API manufacturers.Several factors make India an attractive alternative for sourcing active ingredients. India has low development costs, complex synthesis capabilities, growing experience with cGMP compliance, and a large local dose market in which to gain experience.With these resources, Indian companies can tackle complex syntheses in relatively short periods of time. Further, India's lax patent laws have resulted in strong domestic demand for many finished dose products, giving API and dose form manufacturers more experience with a product over a longer period of time than manufacturers in regulated countries. In fact, new drugs are often launched early, if not first, in India. Thus, India has established itself as a source for both complex synthetic active ingredients and finished dose form products in regulated and unregulated markets.China is also rapidly evolving into a viable source for key intermediates and actives. With many focusing on fermentation products or simple synthetic compounds. Today, the climate in China is very different. This is a result of China's overall economic evolution and entrance into the World Trade Organization, which is expected to expose domestic manufacturers to significantly more competition. As a result, custom manufacturing, which was once illegal in China, is now seen as the most effective way to accelerate the learning curve to producing high quality pharmaceuticals for regulated markets. Both public and private factories are eager to work with western partners and gain the expertise necessary to meet their exact specifications and achieve goals of greater technical skill and increased profitability. Thus, factories are modernizing rapidly, purchasing both technology and expertise in the form of western consultants. However, it is worth noting that the Chinese tend to see custom manufacturing as a step towards achieving their own goals, and western companies are therefore advised to be extremely cautious regarding the transfer of intellectual property to China.As India and China have begun to offer higher quality pharmaceutical API manufacturing machine and intermediates for regulated markets, innovators have started to look to these countries for late stage intermediates, and in some cases have formed joint ventures with local manufacturers. More frequently, innovators use their traditional European custom manufacturers for the finished API or key intermediate, while these manufacturers rely on Indian and Chinese partners in turn for earlier stage intermediates. The especially risk-averse profile of innovator companies with regard to outsourcing suggests that high quality European bulk manufacturers are likely to continue supporting innovator companies for the foreseeable future, but they may increasingly partner with late stage intermediate suppliers in countries with lower development and production costs.Generic pharmaceutical companies, on the other hand, have been far more eager to work directly with China and India, as the strategic sourcing of active ingredients is a necessity for profitability, while intellectual property protection is less of a concern than it is for the patent holders. Manufacturers of generic oral solids, on average, have between 40 and 50% of their cost of goods sold tied up in raw material costs. In a highly contested market where the ability to offer a low price is critical, generic manufacturers seek competitive advantages by finding reliable bulk manufacturers who can deliver at a low cost.The Active Pharmaceutical Ingredients manufacturing plant's role in product development is also increasingly significant. Further, the API manufacturer may play a critical role in the patent challenge process. Beyond the ability to creatively circumvent process patents, the creative development of active ingredients may become fundamental to the patent challenge itself. Anhydrous and mesylate versions of paroxetine are examples of patent challenges that are based on new syntheses and novel processes developed using the expertise of API manufacturers.