Shanghai UTOpharm Co., Ltd._pharmaceutical intermediates,APIs

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ABOUT US

UTOpharm is a professional high-tech company that specializes in researching, manufacturing and selling of API, intermediates and pharmaceuticals. Our company has been authorized to engage in the import and export business.

UTOpharm has made great achievements in fields of pharmaceutical and fine chemical by UTOpharm’s experienced and creative chemists with strong background in drug development. Our company has extensive experience in setting the standard of API and pharmaceuticals, conducting pre-clinical research of innovative drugs and generic drugs, applying for drug clinical research and assisting domestic pharmaceutical companies in registration of drugs. UTOpharm has successfully developed a special Photochemical platform, which helped us realize the commercial production of a series of products involving photochemical reactions, such as Dydrogesterone, VD2, VD3, Nicergoline, etc. UTOpharm is good at process route design, new crystal form development. So far, we has obtained twenty domestic and foreign patents.

UTOpharm’s laboratory in Shanghai is able to perform up to kilogram level experiments, by equipping various synthesizing instruments with size from 0.1L to 50L. The laboratory also has 3 sets of HPLC and 1 sets of GC to guarantee product quality. UTOpharm production base is located in Bengbu City, Anhui Province, covering an area of more than 6000 square meters in which is equipped with a variety of equipments(1-5000L), and low–temperature reaction kettles (500L, -70℃) and hydrogen reactors (500L, 11mPa), which can satisfy a variety of chemical reaction from small-scale tests, pilot experimentsand scale up production. Meanwhile, our company is equipped with many analytical devices, such as HPLCs and GC. Our production base is fully built with GMP standards, which is expected to be completed next year.

UTOpharm lays great emphasis on the customer's demands and regards customer satisfaction as its priority all the time. Furthermore, UTOpharm is endeavored in establishing long-term, various, and mutual-benefit cooperation with companies worldwide.

Basic Activities on:

Pre-clinical research of innovative drugs and generic drugs;

Contract research;

Contract synthesis;

New dosage form

Registration of drugs

Contract manufacturing;

Optimization of synthesis process

Competitive products:

Dydrogesterone, Vitamin D2, Vitamin D3, Nicergoline, Ivabradine HCl，Ulipristal Acetate，Tolvaptan，Prasugrel，Licofelone，Rasagiline Mesylate，Sitafloxacin and their intermediates

UTOpharm’s philosophy:

Excellence Exploitation Innovation

优秀开拓创新

PRODUCT CENTER

Cardiovascular drugs

Spiritual class

Anemia

Steroidal drugs

other

Excellent development and innovation

New drug and generic drug development, approval, clinical approval transfer, drug consistency evaluation, API and pharmaceutical intermediate production, cdmo customization and entrusted processing

Learn more

NEWS CENTER

2020

03-05

Biological "clinical" trials

Following the treatment of fruit wool by physical scouring, the municipal greening and urban appearance bureau is collecting the chemicals in the prevention and control of sycamore fruit balls in this city and other cities, testing and screening the best types of chemicals, optimizing the use methods of chemicals, and exploring a new way for sycamore fruit control. Due to the long growth cycle of fruit balls and great differences in individual conditions of trees, the pharmacological reaction needs long-term observation to draw a conclusion. At present, researchers are stepping up "clinical" trials in order to promote their application in the future. As a street tree, Platanus acerifolia has strong stress resistance and can adapt to the urban growth environment. While purifying the urban air, it also weakens the urban heat island effect and effectively improves the urban ecological structure. However, in recent years, the sycamore fruit wool catkins in the downtown area have had a certain impact on citizens' travel. Therefore, the city's greening Department has carried out research on key technologies for prevention and control of sycamore fruit wool catkins from many aspects. In view of the characteristics of tall trees and difficult prevention and control in the central urban area, the scientific and technological personnel of the municipal greening management guidance Station summarized the research achievements in recent years, collected the current chemicals in the prevention and control of sycamore fruit balls in this city and other cities, tested and screened the best types of chemicals and optimized the application methods of chemicals, in order to explore a new way for sycamore fruit control. At present, drug prevention and control is still in the continuous experimental stage. Due to the long growth cycle of fruit balls and great differences in individual conditions of trees, the pharmacological reaction needs long-term observation to draw a conclusion. In the face of the current situation of great difficulty, long cycle and little preliminary data of pharmaceutical test, researchers are paying close attention to "clinical" test and constantly accumulating experience in order to promote its application in the future.

2020

03-05

"Medicament cleaning"

In April and may every year, the sky of Weifang will be filled with flocs such as Yangxu and LiuXu, which is really a big test for our allergic people. " Mr. Tan, a citizen of Weifang, told reporters, "there is no way. At this time, I can only go out with a mask every day. Otherwise, once I am allergic, it will be very troublesome. The flying catkins not only affect the urban environment, but also affect my normal travel." As soon as the catkins appeared, many citizens put on masks one after another. Citizens complain and sanitation workers worry. It's another "floating season" On the morning of the 15th, on Dongfeng Street in Weifang, the reporter saw that many citizens went out wearing masks because flying catkins began to appear in the sky. "It's hard to go out by car. When you're tired, you can't avoid shortness of breath. These flying catkins in the air are really annoying. They can easily be sucked into your nostrils, which is very uncomfortable." Ms. Wang, who is waiting for the red light on a public bicycle, told reporters, "It is reasonable to say that spring is the best season for outdoor activities, but there are a large number of Yang catkins and willow catkins in Weifang, which directly affects our citizens' outdoor activities. In particular, these catkins fall to the ground and float everywhere at the sight of the wind. It is difficult to clean and affect environmental sanitation, which has become a persistent disease affecting the appearance of the city." In the selection of tree species, tree species such as French Tung are gradually used to replace poplar and willow. Then, the reporter interviewed Master Cheng, an environmental sanitation worker who was cleaning the road. He told reporters that the temperature in Weifang rose slowly this year, and the appearance of Yang catkins and willow catkins was slightly later than in previous years. "Now the catkins have just appeared. It is estimated that during May Day, the catkins will usher in their heyday. At that time, piles of Yang catkins and willow catkins can be seen everywhere on the road, which is very difficult to clean." Mr. Cheng told reporters, "The management of flying catkins has to be managed from the source. If there are fewer poplar and willow species, the flying catkins will naturally be reduced, and the cleaning work in the city will be much easier." "Chemical floc cleaning" has entered the experimental stage, which will reduce the production of flying floc from the optimization of tree species For the "flying catkins" reflected by the public The reporter consulted Weifang natural resources and Planning Bureau. According to the staff, from the perspective of urban greening, although poplar catkins and willow catkins have an impact on citizens' daily life, they should not cut poplar and willow in a large area, but should optimize and adjust the existing forest structure, and gradually reduce the proportion of poplar, willow and other tree species prone to flying catkins during afforestation At the same time, Weifang will select optimized poplar and willow to reduce or even eliminate the production of flying catkins from the source. The work of drug floc cleaning has entered the experimental stage As the maintenance unit of urban landscape tree, Weifang garden is in the "clearing work" According to the staff of the garden department, according to the current statistical data, the poplar or willow that produces flying catkins in Weifang is basically planted on both sides of the highway, the forest protective belt and the junction of urban and rural areas. The planting proportion of poplar and willow in the urban street trees is low, and at present, the street trees are mainly Fatong and other tree species. From the perspective of urban management, this year's Weifang urban Starting from Beihai Road, some poplar trees are selected for drug floc removal experiment. The production of flying catkins is reduced from the source by spraying inhibitors. With the increase of temperature, in the flourishing period of flying catkins, the garden department will send large spraying vehicles to wet the poplar catkins and catkins hanging on the branches by spraying water mist at high altitude, and speed up the cleaning of flying catkins by accelerating the landing of flying catkins to avoid them Drift with the wind. In addition, for the roadside trees that die naturally on both sides of the road, in terms of tree species replacement, priority will be given to the tree species that will not produce flying catkins, so as to reduce the proportion of poplar and willow from the source and achieve both symptoms and treatment. If the experimental work of drug catkin removal is progressing smoothly, this treatment measure will be popularized in time to reduce the occurrence of flying catkins disturbing residents, so as to further improve The urban environment of Weifang in spring.

2020

03-05

ICH is based on biological agents

Whether generic drugs can apply for bioequivalence test exemption has always been a matter of great concern in the industry. In October 2016, the concept paper and drafting plan of bioequivalence test exemption guidelines based on biopharmaceutical classification system. The guidelines are currently in the first stage of the development process (step 1). The document is included in the comprehensive discipline series. The purpose is to provide guiding suggestions for the exemption of bioequivalence test of drugs classified according to the biopharmaceutical classification system. 1. Reasons and necessity of drafting Based on BCS classification, bcs1 and bcs3 drugs can be exempted from bioequivalence test. Prior to this, the European Union, the United States, Canada and who have issued the draft guiding principles / guidelines on the feasibility of drug bioequivalence test exemption based on BCS. The relevant principles of Japan also include the possibility of exemption from drug bioequivalence test based on changes in formulation (see Table 1). However, the BCS based drug bioequivalence test exemption has not yet reached a global consensus, mainly because there are differences in the supporting data requirements for applying for exemption in these guidelines, and even if the scientific data used to support the BCS based bioequivalence test exemption in different countries or regions are the same, there are still differences in the understanding of these data. In addition, there are differences in the theory of biopharmaceutical classification system in different countries or organizations, which makes pharmaceutical companies need to follow different technical requirements when applying for drug marketing license in different countries and regions. In view of the above problems, it is expected that these problems can be solved by coordinating the formulation of a general consensus and exemption requirements for bioequivalence test exemption based on BCS. 2. Problems to be solved 2.1. Description of relevant characteristic indexes of drugs based on BCS classification system Solubility: to judge whether a drug has high solubility or low solubility, it should be defined according to the maximum therapeutic dose or the maximum dose specification on the specific drug label. Permeability: at present, there are differences in measurement methods, whether they are based on in vitro data, in vivo data, or both, and they need to be coordinated; If the applicable method is determined, it shall also clearly judge whether the drug is high permeability or low permeability. 2.2. Consideration of supporting data on bioequivalence test exemption Threshold criteria for dissolution studies need to be established to determine whether the drug is BCS class 1 or class 3 (please note that the bioequivalence test exemption for BCS class 1 and class 3 drugs is applicable and acceptable). It is necessary to formulate the requirements for the comparison between the test drug and the reference drug or the prescription of the reference drug, and what are the key excipients affecting the drug absorption rate and degree. Formulate the standards for quantitative comparison of prescriptions and provide data to prove that excipients are non key factors. The in vitro dissolution test data need to clearly establish the dissolution test conditions. It also needs to be clear whether it is feasible to adopt standards different from the determined conditions, such as the variation range of mixing speed. If it can be adopted, what instructions need to be provided. It should be clear whether the bioequivalence test exemption based on BCS is only applicable to pharmaceutically equivalent products. In addition, when multiple specifications are listed in the reference preparation or reference prescription, for example, 10mg and 20mg rapid release tablets. It should also be clear whether each specification of BCS based bioequivalence test exemption needs to be matched one by one, whether 10mg reference preparation / reference article is compared with 10mg test sample, 20mg reference preparation / reference article is compared with 20mg test sample, or whether after a comprehensive BCS based bioequivalence test exemption is conducted for one specification, other specifications can be exempted according to this result. 3. Significance of drafting guiding principles After the formal introduction of BCS based bioequivalence test exemption guidelines, some in vivo studies used to prove the bioequivalence of drugs may be exempted, which reduces the number of healthy subjects to be exposed to drugs and reduces the cost and time of drug research and development. By accepting the same test methods adopted by pharmaceutical enterprises in different regulatory regions, member states have accelerated the speed of drug approval. In addition, the principle can also be used for reference by the regulatory authorities of developing countries that are not members of IC

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