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cGMP Manufacturing

Product Description
1. Manufacturing facilities ensure: 1) Production flexibility at various scale 2) Total Production Capacity: 726 m3 including pilot production 3) Potent compound manufacturing (OEL Category 3A, CPT 1 Mug/m3) 2. Various Analytical Capabilities: 1) cGMP QC lab with HPLC, UPLC, GC, LC-MS, GC-MS, NMR, XRD 2) ICP-OES, ICP-MS, microbial testing capabilities and others 2) Lab fully compliant to 21 CFR part 11 requirements with comprehension 3. Successful Regulatory Approvals 1) US FDA 2) Australia TGA 3) Japan PMDA 4) Korea MFDS
Yuhan Corporation

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KR
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2015On CPHI since
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4Certificates
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250 - 499Employees
Company types
CMO/CDMO
Departments
Business Development
General Management
Sales
Other
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Sangsun ParkSeoul, Korea, Republic Of
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Categories
Specifications
- Supplied fromKorea, Republic Of
Sales Markets
- Middle East Region (e.g. UAE)
- Oceania
- North America (USA, Canada)
- Africa
- Central America (e.g. Mexico)
- East Asia (e.g. China, Japan, Korea)
- Europe - EU countries
- Europe - non EU (e.g. UK, Russia, ex-CIS countries)
- South America (e.g. Brazil, Colombia)
- South Asia (e.g. India, Pakistan, Sri Lanka)
- South East Asia (e.g. Thailand, Philippines, Singapore)
Yuhan Corporation

-
KR
-
2015On CPHI since
-
4Certificates
-
250 - 499Employees
Company types
CMO/CDMO
Departments
Business Development
General Management
Sales
Other
-
-
Sangsun ParkSeoul, Korea, Republic Of
-
More Products from Yuhan Corporation (3)
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Product R&D Service
1. Process R&D 1) Synthetic route scouting 2) Process Optimization 3) Impurities fate/purge study 4) Control strategy: PAR & DOE 5) Technology transfer 6) Procative trouble shooting 7) Non-GMP Kilo Lab Scale(OEL 1Mug/m3) 2. Analytical R&D 1) Method development 2) Standard characterization 3) I...
Yuhan Corporation resources (2)
Frequently Viewed Together
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Product Electron Beam
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Product API Services, Chemical Development & Manufacture
Almac's strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.
Our technical expertise and extensive facilities enable us to offer integrated API contract ma... -
Product Formulation Development
Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation. -
Product Certified ecotoxicological studies
Ecotoxicological studies conducted by Lukasiewicz - IPO:
-chemical analyses in the range of environmental studies:analysis of concentrations/residues of chemical substances in water, soil, plant and animal material, food, fate and behaviour of chemical substances in the environment
-evaluation ... -
Product Core Technologies and Services
• API / GMP Manufacturing • Rapid Process Development, Flawless Upscaling, and Economy of Scale-Production • Simulated-Moving Bed (SMB) Chromatography • Heterocyclic, Hazardous and Malodorous Chemistries • Organometallic and Cryogenic Chemistry • Transition-Metal Catalysis • High-Pressur... -
Product Batch Testing & EU Batch Release / Certification
QP Declaration
QPLab will evaluate the information regarding active substances manufacturing sites of the product, to assess the EU GMP compliance and issuing the QP Declaration.
QP Batch Certification SetupIn this step QPLab will have a complete oversight ... -
Product Formulation Development
Formulation & process development of complex oral solids drug products. Specialized in solubility enhancement, drug delivery, controlled release, functional coating, granulation, pellets & micropellets. From technical feasibility to GMP for clinical trials and commercial manufacturing.Core compente... -
Product PBD Core™
Advanced intermediate.Enables rapid synthesis of PBD payloads.Suitable for up to phase I clinical studies with process, validation to support path to commercial approval.Contact one of our experts to request a free sample -
Product GMP API Manufacturing
Process development and manufacturing services represent a core part of our business. We utilise accumulated know-how and advanced technologies and provide everything that you desire from a high-quality API supplier. ChemCon is also experienced in manufacturing regulated substances and has the flexibility ... -
Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i... -
Product Integrated offerings
Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
Core Capabilities:Sterile-fill finish development and manufacturingO... -
Product SOFTGELS
At Softigel, we offer much more than traditional softgels, including everything from a single unit dosage form, to multiple delivery systems in a single dose. Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS Classes II, III and... -
Product Research & Development Capabilities
PHT International Inc. offers a wide range of services which includes research & development capabilities. Features: it includes process development, process improvement, sample repackaging, sample production, sample analysis. Contact us for more information. -
Product Pharma Separators
GEA pharma separator skids aseptic and pure are energizing the industry with two comprehensive and sophisticated separator lines and one revolutionary new multi-bowl solution. These plug & produce pharma separator skids are breaking new ground in ensuring maximum safety, maximum yield and perfect adaptatio... -
Product Biosimilars Portfolio
• Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing... -
Product Stability Studies
Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes stability studies. Kymos provide full service of ich and on-going stability programs for third parties. The services, at client's choice, can include: method tra... -
Product HCG/Chorionic Gonadotrophin for Injection -OVIGIL HP 5,000 IU
The Gonadotropin That Delivers – Precision, Reliability & Consistency
This product is available as a combi pack of Chorionic Gonadotrophin for Injection BP 5000 IU & Sodium Chloride Injection BP 0.9% w/v (HCG Injection).
• Use: This highly purified Human Chorionic Gonadotropin... -
Product Commercial Support
Selectchemie AG provides a wide range of services including commercial support. Our experienced professionals are at your service at locations in 18 countries to deliver tailor-made solutions according to your needs. Contact us for more information. -
Product R&D Services
Our R&D Services are categorized into 8 streams: • Material Science Services
• Metal and Organic Scavenging Screening Services
• Organic Synthesis Services
• Catalysis Services
• Process Services
• Chromatography and Purification Services
• Method D... -
Product Brand and Promotional Analysis
Powered by the IQVIA CORE™, our promotional analysis can help you understand the trajectory of your brand and measure its progress along the way. We can help you see where you are today, where you're going and help you make adjustments as part of your path forward. Find out what you need to know about •... -
Product Excipient Quality Testing and Selection Services
Excipient testing, composition and variabilityExcipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases the exipients are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.
... -
Product 2D Automated Closed Platform
Kolon Biotech's 2D Automated Closed Platform can manufacture adherent cells in large scale with competitive costs and minimum contamination risk. With an automated system using a machine manipulator, we can set up the operation conditions and minimize human error ensuring batch-to-batch consistency. Th... -
Product Mérieux NutriSciences | Pharma & HealthCare complete services
Download our brochure: https://bit.ly/4dzryoA
Our complete range of Pharma services include: • Quality controls • Investigation studies • Absorption studies • R&D and validation activities • Stability & storage • Cleaning and disinfectants validation • Environmental monitoring -
Product Analytical Services - Inhaled Products
With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterise inhaled delivery platforms, especially DPI, pMDI and nebulised products.
To ensure seamless support for your development... -
Product Complete Characterization Testing Solution For Iron Carbohydrate
Method Development & Validation @ACCUPREC
1)Iron Chelation Assay (labile iron by U.V spectroscopy) Validated method
2)Polymorphic estimation of Iron carbohydrate by XRD
3)Estimation ratio of Fe3+ to Fe2+ ion validated method
4)Morphology estimation of iron carbohydrate
5)... -
Product Customized silicone syringe plungers by RAUMEDIC
Syringe plungers and stoppers made of our self-developed, slide-optimized silicone that comes in medical-grade quality have low break-loose force. This enables injections to be controlled and dosed much easier.
• Clean manufacturing conditions • Freedom of design and shape when using silicone • Small... -
Product Computer System Validation (CSV) Solutions
ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experien... -
Product Zinc Oxide Mousse
Zinc Oxide Mousse: protects & hydrates. Soothes dry, itchy and red skin irritations. -
Product Ligand-binding Assays
Intertek offers wide range of pharmaceutical services which includes ligand-binding assays. It belongs to immunochemistry services category. It includes elisa, electrochemiluminescence (ecl), radioimmunoassay (ria), etc.
To learn more, visit our website:
www.intertek.com/pharmaceut... -
Product Elemental Impurities
In light of the growing interest of the pharmaceutical world on the issue of determining Elemental Impurities in accordance with tables 1, 2a, 2b and 3 of the ICHQ3D, Neotron Pharma laboratory, thanks to its decades of experience in the analysis of metals, has developed a series of analytical proposals to ... -
Product Facility Planning
Csv Life Science can support customers in all phases of the project, right from the very beginning. This includes facility planning activities, aimed to a better and conscious defnition of your new or upgraded process needs
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Product NEW! Fillchoice® Refill KIT
A Ready-to-Transfer CSTD for drug reconstitution and administration to the patient from one or multiple drug vials.
• PATENDED In routine clinical practice of drug reconstitution, health care workers are at serious risk from the use of syringes with needles and exposure to the potential release o... -
Product Research & Development
Discovery - Biology, Lead Optimization, Libraries, Synthetic & Medicinal ChemistryDevelopment - Chemical Process R&D, Fermentation, Formulation Development, High Potency, Kilo Lab & Small Scale Manufacturing, Lipid Nanoparticle, Method Development/Material Science, Rare/Orphan, Separation Scien... -
Product The Specialist Integrated CDMO
Hovione helps you bring new medicines to patients in an unprecedented speed.
As a fully integrated CDMO, we offer over 60 years' experience in chemical process development and manufacture of APIs. Our more recent capabilities in Drug Product together with our innovative science, the most up-to-... -
Product Aerosol & Spray particle size distribution analytical services
We provide cGMP analysis of sprays and aerosols: droplets particle size distribution over time of sprays and aerosols, using laser diffrcation technique (Spraytec by Malvern Panalytical) -
Product Impurity Synthesis
Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Reserach Organisition) established in year 2001. Presently our group consists of more than 130 Scientists with 3 R&D Centres offering its expertise in Custom Synthesis, Impurity synthesis, Isotoped lebelled compound... -
Product Highly Potent Pharmaceutical Principles
Olon relies on one of the most extensive expertise in handling highly potent pharmaceutical principles at global level, has raised the level of containment up to the actual standards and very large scale putting in place a set of primary and secondary containment designed to avoid the active substances... -
Product Quality Control & Testing Services
Thépenier Pharma & Cosmetics provides comprehensive quality control and testing services to ensure the highest standards for pharmaceutical products. The service includes analytical testing, stability studies, and quality assurance processes. Utilizing state-of-the-art equipment and methodologies, the ... -
Product Small scale synthesis
• Route scouting • Feasibility studies • Synthesis of compounds in mg/g scale • Metabolite synthesis • Preparation of standards / reference substances • Impurity profiling • Impurity reference synthesis • Synthesis of stable isotope labelled substances -
Product Chondroitin Sulfate
Fine Foods & Pharmaceuticals N.T.M. Spa offers wide range of API which includes Chondroitin Sulfate. Contact us for more information. -
Product Vinpocetine-aconitum 5, 10 Mg Hard Capsules or Tablets
Vinpocetine is a time - tested remedy for the treatments of cerebral blood flow. Vinpocetine reduces the brain cell sensitivity to the lack of oxygen and protects them from damage, does not increasing the total blood pressure. It has been observed that vinpocetine has a positive effect on cognitive functio... -
Product Development of Formulation
Formulation Development- Cosmetic products
- Medical devices (skin and mucous membranes)
- Oral supplements
- Veterinary products
- Biocidal products
- Topical medicines
Stability tests - evaluation of the stability of cosmetic products, medical devices, food supplements and bioci... -
Product Partner laboratories
BioChem GmbH offers a wide range of services which includes partner laboratories. Features: Identification of impurities, extractables / leachables, test for pyrogens in rabbits according to Ph Eur.. 2.6.8 / USP, test for abnormal toxicity Ph. Eur. 2.6.9 / USP, special techniques, XRPD, electron, NMR, LC-M... -
Product Syringe and Vial Filling for Clinical and Commerical
Lifecore's experts have gained the know-how to build processes around your requirements for smooth scale-up and high-quality manufacturing.
Whether we're your primary partner or a secondary source for manufacturing, we ensure you're fully satisfied with the final produ... -
Product Laser Micromachining Services & Systems
From pinholes in stainless steel discs to complex arrays in semiconductor guide plates, we provide a wide range of ultra-high precision laser drilling, cutting, milling, scribing and ablation contract services (and systems) for numerous applications in industry & academia. With over 45 years of experie... -
Product Global Clinical Trial Supply
Accelerate your timeline, with flexible, on-demand delivery. We'll design and develop your packaging, labelling and distribution strategy for Phase I, Phase II and Phase III clinical studies, so you'll no longer have to worry about the challenge of getting your drug product to multiple sites in time fo...
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