Search

申美

CN / EN

版权信息

Copyright:Shanghai Shenmei Pharmaceutical Technology Co., LTD | 沪ICP备09052914号-1

DEVELOPMENT HISTORY

企业文化

ABOUT US

公司简介

HONORS

荣誉资质

CULTURE

企业文化

Have a team with professional experience in marketing, technical services, regulatory management and external collaboration.

ABOUT US

Supplier classification

按供应商分类

Our company's purpose is to unite us to innovate in order to bring real success.

Functional classification

按照功能分类

Our company's purpose is to unite us to innovate in order to bring real success.

PRODUCTS

Have a team with professional experience in marketing, technical services, regulatory management and external collaboration.

REGULATION QUALIFICATION

Have a team with professional experience in marketing, technical services, regulatory management and external collaboration.

Have a team with professional experience in marketing, technical services, regulatory management and external collaboration.

The 2nd National Medical and Health Science Innovation Conference: Innovation and Technology Leading Development
The
Recently, the news about the 2nd National Medical and Health Science and Technology Innovation Conference will be held in Beijing on January 17-18, 2019. According to the organizer Puren Union (Beijing) International Health Management Co., Ltd. and the organizer of the National Research Institute of Beijing International Medicine Research Institute, the conference will focus on "innovation and technology to lead development, build a strong medical and health country, and build a community of human health destiny. "This theme carries out in-depth exchanges within the industry, promotes the flow of talents, and the promotion of Chinese medicine culture at home and abroad. At such a peak event in the industry, if you are fortunate enough to be judged as a talented person, you can be incorporated into the history of the alliance, set up an international expert tour group, and you can go international to promote the essence of Chinese medicine. At the same time, the purpose of the conference is to hope to take this opportunity to promote the formulation and implementation of Chinese medicine standards, and to regulate and assist the security and development of folk secret recipes. Focus on creating scientific and technological innovation enterprises to be selected as honorary candidates, and authorize the meeting to designate brands to promote development; landing national famous doctors, famous drugs, and famous enterprise alliance plans to achieve online and offline interactions. Of course, since the venue of the conference was originally set at the Great Hall of the People's Government of the Central People's Government, but due to state visits, meetings, etc., it is now moved to the West International Trade Hotel, but all the original application standards remain unchanged – no matter what Participants are still individuals, products and enterprises, all of them are unconditionally placed in accordance with the following specific requirements, providing all the documents required for regulatory approval. For example, if the unit is required to submit a business license, a copy of the copy (with a red stamp), product description, product photos and product qualifications, the product without the batch number will be reviewed and checked by the general manager of the organizing committee. Make a unified arrangement; the unit legal person shall provide two copies of the ID card, four photos of the front half body, and the unit's paper materials and electronic version of the publicity materials, and submit them to the organizing committee. Personal registration is a bit simpler, just submit 2 copies of your ID card, half-length photo and personal autobiography. However, the quality requirements for individuals are that the research direction is in line with the development trend of science and technology or belongs to the national strategic emerging health industry. Chinese medicine professionals who are not more than 60 years old and have a long-term skill in the health field and have great love (enterprise technology talents can be free from job title restrictions, no academic requirements). It has achieved high-level innovative achievements, outstanding performance in its health industry or field, and has great potential for innovation and development, with a primary focus on research and development workers in the front line of health research. Has a strong scientific research leader and team organization management ability leader. Secondly, enterprises and institutions that apply for special products for the conference need special products to refer to products that are superior to similar products and are representative and provide publicity and promotion products approved by the conference to countries along the country and along the “Belt and Road”. Require a letter of business license, copy of the copy (with red stamp), product batch number, product description, inspection certificate, electronic version of the promotion materials and relevant documents for the provision of special products, such as a copy of two ID cards Four half-length photos, etc. It is worth mentioning that if the enterprise unit can successfully name this conference, it will enjoy the section of the Chinese Health Care Committee CHTV People Health Channel "Chinese Renyi", which will be titled to the national video broadcast. In the course of thousands of years of development, Chinese medicine has continuously absorbed and integrated advanced science and technology and humanistic thoughts in various periods, constantly innovating and developing, the theoretical system has become more and more perfect, and the technical methods have become more abundant, forming distinctive features. In order to prevent the Chinese medicine industry from breaking down, in order to promote this national quintessence, the "Second National Medical and Health Science and Technology Innovation Conference" is based on the present, to understand the futu
Dozens of experts and well-known overseas Chinese in the field of medicine
Dozens
Modern biomedical innovation, how to find the right point and the foothold? On November 23, the 18th Huachuang Association Biomedical Special Session, dozens of experts and well-known overseas Chinese in the field of medicine gathered together to face the pain points and focus issues in biomedical innovation, and expressed their opinions and opinions. To make the "relief medicine" that benefits the people. In the new era, what is the new connotation of drug quality? What kind of medicine is the safe medicine in the hearts of the people? Professor Wu Zhiang, an expert member of the Drug Consistency Evaluation Committee of the State Food and Drug Administration, believes that since 2015, the state has intensively introduced seven important documents in drug supervision.
Provincial Food and Drug Administration: Promoting the high quality development of the pharmaceutical industry
Provincial
AtthebeginningoftheestablishmentoftheProvincialDrugAdministration,itcoincidedwiththedeploymentoftheprovincialpartycommitteetocarryouttheemancipationofthemindtopromotethehigh-qualitydevelopmentofJilin.Theprovincialbureaucombinedwiththeactualsituation,thinkingwithproblems,discussingwithproblems,solvingproblemswithproblems,andworkinghardtosolvecontradictionsandsupplements.Shortboard,turntostyle,improveefficiency,ensuresafety,andpromotedevelopment. "Inthebigdiscussionactivities,weinsistedonputtingtheemancipationofthemindtoboostdevelopmentconfidence,evokethespiritofattackinghardshipsandappointingentrepreneurs;andembodytheresultsoftheupdatedconceptinsafeguardingthesafetyofthepeople'smedicationandpromotingmedicine.Thespecificmeasuresandmethodsforthehigh-qualitydevelopmentoftheindustry."Duringtheconversation,LiuBaofang,thedirectoroftheProvincialFoodandDrugAdministration,wasfirm. Accordingtoreports,thisinstitutionalreform,thefunctionoftheprovincialdrugregulatorydepartmenthasundergonegreatchanges,mainlyresponsibleforlicensing,inspectionandpunishmentofpharmaceutical,medicaldeviceandcosmeticproductionlinks,aswellasdrugwholesalelicense,retailchainheadquarterslicense,Internetsales.Third-partyplatformfiling,inspectionandpunishment,moreprofessionalandtechnicalrequirements. AsoftheendofOctober,theprovincehadatotalof367pharmaceuticalmanufacturers(includingmedicalinstitutions),704pharmaceuticalwholesalecompaniesandretailchainheadquarters,290medicaldevicemanufacturers,40cosmeticsmanufacturers,and13690drugapprovals.Itaccountsfor8.2%ofthecountry.Adheretothegoalorientationandproblemorientation,adapttothenewera,newsystem,newfunctions,focusonthestandard,resolveconflicts,furthersolvethedrugsafetyconcernsofthepeople,andpromotethehigh-qualitydevelopmentofthepharmaceuticalindustrythroughprofessionalservices.TheProvincialFoodandDrugAdministrationhasstudiedandresolvedthekeypointsinthebigdiscussion. Intermsofstrongsupervision,theProvincialFoodandDrugAdministrationhasimplementedscientificsupervision,targetedsupervision,andeffectivesupervision,andactivelyintroducedmarketregulationmechanismstocomplementthegovernmentandthemarket's“twohands”.Specifically,theProvincialFoodandDrugAdministrationwillspeeduptheimprovementofthevaccinedrugregulatorysystem,theconstructionofprofessionalinspectors,reportingrewards,drugqualityriskassessment,qualityinspectionandtesting,strengtheninglogisticsandtransportationsecurity,productrecall,increasingpenaltiesforviolations,andstrengthening9long-termmechanismssuchasvocationalskillstraining,strictpreventionofriskhazards,strengtheningsupervisionintheworkplace,strictpost-punishment,strengtheningtechnicalsupport,preparingthe"InspectionOperationManual",leveragingthe"DigitalJilin"construction,planninganddesigningdrugs"digitalsupervision",Furtherstrengthenthedrugsafetysupervisionwork,realizetheclosed-loopsupervisionoftheentireprocess,thefullcontroloftheresponsibility,andthefullimplementationofsupervision. Strongsupervisionisalsopromotingdevelopment.LiuBaofangsaid,"Thedrugsupervisiondepartmentwillhighlightthemainresponsibility,rationalizeregulatorymatters,openup'capillarybloodvessels',removetheblindspotsofsupervision,conscientiouslyimplementthe'fourmoststringent'requirements,andregulatetheproductionandoperationorderofmedicines,medicaldevicesandcosmetics.Inaccordancewiththelaw,severelypunishviolationsoflawsandregulations,andfullyprotectthesafetyofpublicuseofdrugs." Intermsofpromotingdevelopment,theProvincialFoodandDrugAdministrationwillconscientiouslyimplementthedeploymentandrequirementsoftheprovincialpartycommitteeandtheprovincialgovernment,activelybuilda"pro-"and"clear"political-businessrelationship,furtherimproveserviceefficiency,andactivelypromotethe"distributionservice"and"onlyrunonce"reform.Continuetopromotethereformofthedrugandmedicaldevicereviewandapprovalsystem,increasethesupportforenterprisesthatpasstheevaluationofthequalityandefficacyofgenericdrugs,andpromotetheimplementationofthedruglistingpermitholdersysteminourprovince;guideenterprisestoincreaseR&DinvestmentandimproveIndependentinnovationabilityandleveltoenhancecorecompetitiveness.Activelycarryoutthe"consultation"serviceofthegrassrootsandenterprises,strivetobringthepolicytothedoor,puttheserviceinplace,activelycreateasoftenvironmentconducivetothedevelopmentoftheenterprise,promotethecompanyoutofnothing,andpromotetheproductstohaveanewlife.
Provincial Food and Drug Administration: Promoting the high quality development of the pharmaceutical industry
Provincial
Provincial Food and Drug Administration: Promoting the high quality development of the pharmaceutical industry

TECHNICAL SUPPORT

NEWS CENTER

Have a team with professional experience in marketing, technical services, regulatory management and external collaboration.

2018-12-18 16:50:00
Common types of direct compression accessories and characteristics
MicrocrystallinecelluloseThisproductiswhiteoroff-whitepowder,odorless,tasteless,insolubleinwater,ethanol,acetoneortoluene,hasverygoodcompressibility,andhascertainfluidityanddisintegration.Itisatablet.Excellentfillerandeffectivedryadhesive,ithasgoodhardnessafterbeingpressedintotablets,anddoesnotaffectdisintegration.Thevarietyhasalargecapacityforthedrug,anditsdosagecanbefrom5%to65%.However,thisvarietyishygroscopic.NowtherearealreadyproductsinChina.Pre-gelatinizedstarchThisproductiswhitepowder,odorless,tasteless,goodfluidity,nationalproductangleofreposeis36.6degrees,goodcompressibility;lubrication,canreducetheforceofthetabletfromthediehole;goodThedisintegrationanddryadhesionincreasethehardnessofthetabletandreducethefriability.Thisproductisanidealmulti-functionalauxiliarymaterialfordirectcompressionofpowder.Thedosageisgenerally5%~20%.Lactosespray-driedlactoseisanauxiliarymaterialusedfordirectcompressionofpowder.Itisawhitecrystallinepowderandhasnohygroscopicity.Thesurfaceofthepressedtabletissmoothandbeautiful,andthedrugisreleasedquickly.Thefluidityandadhesionaregood.Filler.Whentheamountismorethan50%,thehydrophobicityofthedrugcanbeimproved.SodiumcarboxymethylstarchThisproductisanexcellentdisintegratingagentfortablets.Itiswhiteoroff-whitepowder,odorless,hygroscopicinair,dispersedintoaviscouscolloidalsolutioninwater;hasgoodhydrophilicityandwaterabsorption.Swellability;andgoodfluidityandcompressibility,canimprovetheformabilityofthetablet,increasethehardnessofthetabletwithoutaffectingitsdisintegration.Fortabletsofpoorlysolubledrugs,thisproductcanimproveitsdisintegration.Thegeneraldosageis1%to8%.CalciumhydrogenphosphateThisproductisawhitepowder,odorless,tasteless,insolubleinwaterorethanol,hasmoistureresistance;hasgoodfluidityandstability,andisinexpensive;thepressedtablethasgoodhardness.Whenthetabletcontains50%calciumhydrogenphosphate,thedisintegrationisveryrapid.Micro-silicagelThisproductisalightwhiteanhydrouspowder,odorless,odorless,largespecificsurfacearea,isacommonlyusedtabletglidant,hasagreateradhesiontodrugs.Thehydrophilicpropertyisstrong,andwhenthedosageisabove1%,thedisintegrationofthetabletcanbeaccelerated,andthedisintegrationisextremelyfine,therebyimprovingthedissolutionofthedrugandfacilitatingtheabsorptionofthedrug.Thegeneraldosageis0.15%to3%.MagnesiumstearateThisproductisawhite,easyandno-sandfinepowder.Ithasaslipperyfeelwhenincontactwiththeskin.Itisinsolubleinwaterandhasgoodadhesion.Thisproductisacommonlyusedhydrophobiclubricant,whichcaneffectivelysolvethestickingphenomenon,andthesurfaceissmoothandbeautiful.Thegeneraldosageis0.2%to1%.Otherssuchaslow-substitutedhydroxypropylcellulose,starch,talc-magnesiumstearatemixedpowder,aluminum-magnesiumrawpowderandthelike.
2018-12-18 16:50:00
The development of pharmaceutical excipients is getting healthier
Market size is about 5 billion
China's pharmaceutical excipients industry is highly fragmented. Up to now, there are many statistics on the scale and current status of the domestic pharmaceutical excipient market, but they lack authority. How large is the size of the entire market, and in the absence of relevant statistics, can it give a rough figure through scientific and reasonable analysis and inference? Yu Zhanwen, secretary general of the China Pharmaceutical Industry Research and Development Promotion Association, believes that the variety of pharmaceutical excipients is not as easy to manage as drugs, and the statistics of relevant market data are difficult to be precise, but some industry insiders who understand the development of the industry can follow their own business. Experience and give a rough outline by scientific analysis of relevant data.
“Over the decades of development of excipients, almost no enterprises have specially developed new materials for pharmaceutical excipients.” Wang Ran, general manager of Tianjin Ailei Pharmaceutical Materials Co., Ltd. pointed out that only cydex's beta-cyclodextrin derivative has been produced so far. The materials are specially developed for medicinal use. Most of the varieties are made in other industries (such as fine chemicals, food, cosmetics), and then transferred to pharmaceutical excipients. For example, some large-scale pharmaceutical excipients such as starch, lactose, and cellulose all fall into this category. At present, there are few companies producing starch in China that apply for pharmaceutical production approval for medicinal purposes. Many pharmaceutical excipients only account for a small proportion of producers' production. If the requirements for pharmaceutical excipients are too high, some manufacturers may abandon the production of pharmaceutical excipients and switch to other industries. It is precisely because of this consideration that the state does not currently require GMP certification for pharmaceutical excipients, but only for certification. Therefore, market information on pharmaceutical excipients is difficult to count.
Wang Ran, who has been in the pharmaceutical industry for decades, emphasizes that the prescriptions for preparations are fixed, and the production companies generally have little difference. According to conservative estimates, pharmaceutical excipients account for 5% to 10% of the cost of preparation products. These preparations include chemical preparations, biochemical products and proprietary Chinese medicines. As long as the output values ​​of the above three are known, the pharmaceutical excipients can be roughly deduced. output value. According to data released by the Ministry of Industry and Information Technology, in 2008, the chemical preparation industry realized a total industrial output value of 233.6 billion yuan, the biochemical and biochemical products manufacturing industry completed 76.87 billion yuan, and the proprietary Chinese medicine manufacturing industry reached 177.94 billion yuan. 488.41 billion yuan. According to the average profit rate of about 20% in the pharmaceutical industry, according to conservative calculations, the total output value of domestic pharmaceutical excipients in 2008 was about 5 billion yuan.
Another method is to use bulk products to calculate, because bulk products account for a large proportion of the entire pharmaceutical excipients. For example, lactose, starch, mannitol, cellulose ethers, resins and hollow capsules in solid preparations, glycerides in ointments, PEG, etc., sucrose, sodium chloride, etc. in liquid preparations, etc. About 5 billion yuan.
In addition, it can also be measured by the sales of pharmaceutical excipients. At present, there are about 50 relatively standardized pharmaceutical excipients in China, with annual sales of around 30 million to 80 million yuan and total sales of 2 billion to 4 billion yuan. In addition, there are more than 10 foreign-funded pharmaceutical excipients in China, with a conservative estimate of 40 million yuan in annual sales, and total sales of about 500 million yuan. The sales of these companies add up to about 4.5 billion yuan.
"There is statistics that the total output value of the domestic pharmaceutical excipients industry is about 100 million US dollars. This figure is not credible." Yu Zhanwen believes that according to scientific analysis and inference, the total output value should be 600 million to 700 million US dollars. The growth rate is generally the same as that of the pharmaceutical industry. In 2008, the growth rate of the domestic pharmaceutical industry was about 25%, and the growth rate of the pharmaceutical accessories industry was probably such a trend.
Broad prospects for industrial development
According to relevant data, in 2001, the global market for pharmaceutical excipients totaled about US$3 billion, of which about 70% were in Europe and America, and 15% in Japan, with an 
2018-12-18 16:49:00
Promising prospects for pharmaceutical excipients
The domestic pharmaceutical excipients industry started late, and there are many problems in terms of scale, management regulations, and standards. Recently, China has researched and implemented the DMF (main quality management of pharmaceutical raw materials) system to strengthen raw materials, excipients, chemical intermediates and Management of pharmaceutical packaging materials. The purpose of promoting DMF is to improve the status quo of the auxiliary materials industry, and at the same time drive the preparation manufacturers not only the product quality, but also must go out and learn more about the whole production process and quality of the raw and auxiliary materials packaging materials, so that the quality of the auxiliary materials will be greatly improved. The auxiliary industry is good news. The 21st century international pharmaceutical market will be the day of new pharmaceutical preparations