Our product applications Spread all over the worldOur product applications Spread all over the world...
Transcript of Our product applications Spread all over the worldOur product applications Spread all over the world...
Contract ManufacturingYongtai provides contract manufacturing service for global pharma&chem innovative industries.
Key strength•Projectmanageapproach•Quickresponsiveness•Flexibility•Confidentiality•StrictlyimplementIntellectualPropertyProtection(IPP)policy
1.1ProjectInquiry
IInquiryResponse
2.1Initialreply2.2 CDA signing2.3 Technical packageevaluation2.4Projectproposal2.5 Visit/pre-audit
IInquiry Projectstart-up
3.1Projectteam/projectmanager3.2Processtransfer3.3 Lab process
01 02 03
Toller qualification
4.1Samplequalification4.2QMSaudit4.3EHSaudit4.4 CMO contract
Commercial Phase
5.1Pre-production activities5.2Production campaign5.3Productrelease5.4Projectshipment5.5Summaryreport
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New Flagship Site
Total area: 120000 square meter.Total investment: USD100 millions .10 comprehensive workshops,Total
reaction volume will be 1500m3
Designed and built to comply with cGMP, will be approved by U.S. FDA later.
Key Technologies
Liquid crystal intermediate
Pharmaceutical intermediate
Agrochemical intermediate
Reaction Type (Example)
Fluorination Halogen exchange, Schiemann reaction
Halogenation Bromination, Chlorination
Photo-Chlorination/Bromination Chlorination/Bromination on aliphatic side-chain
Diazotization Sandmeyer Reaction, Gattermann Diazonium Salt Substitution reaction, Diazonium salt Hydrolysis
Organometallic Grignard, n-BuLi
Coupling Reaction Suzuki Coupling
Acylation Friedel-Crafts,
Ammonolysis Amino substitution
Reduction Catalytic Hydrogenation, Metal Hydride
Nitration Aromatic Compounds
Quality Management SystemLearning, Exploring & Improving,Customer’s satisfaction is what we are seeking for.
Each Yongtai’s site has in place a quality function, independent of production, responsible for assuring that our products are of the quality required for their intended use and that quality management systems are maintained.
Quality System
Facilities & Equipment System Laboratory C
ontrols System Materials System
Packaging & L
abel
ing
Syst
em
P
rodu
ctio
n System
QC support (IPC)
Batch sheet QA approval
Process chemist tech support
QA batch Sheetimplementation monitoring
QA review/execute batchsheet
QA release product
Pre-shipment sample
Customer approval
Shipment&Tracking
QC test
QA release
Raw material
Finished products
R&D
Two R&D centres located at Beijing and Zhejiang respectively-Total 105 hood, including 26 WALK-IN HOODDedicated Kilo labsState-of-art R&D test equipments: HPLC, GC, IR, DSC, LC-MS, GC-MS etc
Effective Project Management- Key to Success
Confidentiality
By choosing Yongtai as your partner, you get a dedicated team working in close partnership with your in-house experts.
Custom manufacturing is a trust-based business. Ensuring strict confidentiality is an aspect of our business principles which we at Yongtai Technology take most seriously.
Dedicated & experienced Project ManagersProject Managers understand the development process and commitment to meeting your timelines and other needsProject Managers enjoy the respect and cooperation of the many functions not under their direct supervisionWe establish direct contacts between your and our specialists in functions like Process Development, Analytics, QA, Regulatory Affairs and EHS.Direct communication channels lead to an efficient and smooth working process.According to your needs you will receive regular updates on your project: In telephone conferences, E-mails (e.g. weekly reports) or visits at Yongtai or at your place.
A. Strict information security regulationsB. CDA included in contract C. Confidentiality agreement with all employees D. Constant focus on Information Security E. Data archive separationF. Restricted physical and logical access management G. Selected e-mail encryption programs H. Encrypted Document Management Software installed on every computerI. Password protected network and workstation accessJ. Anti-Virus, Anti-Spam filter protection
Spread ...all over the world
Except comprehensive fluorination commercialization technology, we also developed special expertise in the following key & challenging technology area:
The largest manufacturer of fluoro-aromatic products
Suzuki CouplingGrignard, n-BuLiCatalytic Hydrogenation, 5bar~60barLow Temperature reaction (-70℃)Carbonylation by CO or CO2
Oxidization
heterocycle compound synthesis technology
Pyrazole
Pyrazine ramification
Pyrimidine
Pyridine ramification Quinazoline ramification
Indole ramification Benzimidazole ramification
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R2 R3
R1
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OR
NH
N
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R
HN
NN
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RN
CN
R1
R2 R3
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New Site Capability-Commercial Production
10 comprehensive workshops with refining, drying, packing and clean roomTotal 1500m3 reaction volumeHydrogenation Capacity: 3000L*4reactors Reaction temperature range: -70℃ - +250℃Pressure up to 60barsPurified water system 2t/hNitrogen gas 2 sets, 300m3/h100, 000 class Finishing Area
Yongtai’s EHS System
Our EHS work focuses on below: Environmental protection Health protection Work and process safety (HAZOP) Meet national and international EHS regulations Operate as a responsible corporate citizen Product stewardship safety Emergency management Transportation safety Continuous improvement
1000m3/d waste water disposal plant in the new site