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cGMP Manufacturing

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

  • KR
  • 2015
    On CPHI since
  • 4
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Specifications
  • Supplied from
    Korea, Republic Of

Yuhan Corporation

  • KR
  • 2015
    On CPHI since
  • 4
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO

More Products from Yuhan Corporation (3)

  • R&D Service

    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...
  • Leaflet

    Product Leaflet

    Yuhan Corporation 
  • Leaflet

    Product Leaflet

    Yuhan Corporation 

Yuhan Corporation resources (2)

Frequently Viewed Together

  • Product Microbiology

    Excerpt from the range of services offered by our microbiological department: • microbial contamination testing (bioburden) • identification of microorganisms • sterility testing • biological indicator testing • bacterial endotoxin testing (LAL), rFC testing
    • assay of antibiotics • effi...
  • 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 14C Radiolabelling

    Almac has extensive experience in the synthesis and analysis of stable (non radio-active) and 14C isotope labelled compounds – from drug discovery through to launch – we can label any compound at any stage, including small molecules, peptides and larger bio molecules.

    Our custom radiolabell...
  • 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 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 Reference Standards

    Pharmaffiliates is Supplying all the Pharmacopoeial Reference Standards (i.e. USP, EP, BP, IP, JP).Apart from this we offer Pesticide Standards, Phyto-chemical Standards, Food & Environmental Standards, etc.
    For more details please send your enquiry on marketing@pharmaffiliates.com
  • 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 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 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 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 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 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 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 Electron Beam

    There is much to consider when choosing a sterilization technology. Sterigenics’ expert advisors look forward to working with you to understand and achieve your unique product goals. We offer all major sterilization technologies: Gamma Irradiation, Ethylene Oxide & Electron Beam as well as innovativ...
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • 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 RoSS® Shell: Protection of single-use bags

    Protect your single-use bioprocess containers: RoSS® Shells - abbreviated for Robust Storage and Shipping - reduce product loss towards 0%. Compatible with all available sizes and types of single-use bags, RoSS enables standardized and scalable end-to-end process solutions for fluid management and col...
  • Product Chewable Tablets

    HERMES PHARMA offers a wide range of user-friendly dosage forms which includes chewable tablets.Chewable tablets are a convenient, more agreeable alternative to conventional tablets. As they are chewed, they spend longer in the mouth and are therefore tasted more thoroughly. We use flavorings, as required,...
  • Product CDMO Services - API

    small moleculepeptide
    biologics
  • Product UniLayer - 5mg Montelukast Sodium BP

    This product is suitable for children and adults, as a delivery system when taking this medication. 

    Must be taken with water or beverage of choice. 

    We are looking for partner on a CDMO bases. 
  • Product Packaging, Quality Control, Storage, Cold Chain

    Within the contract development and manufacturing, IDT Biologika GmbH provides a wide range of other pharmaceutical services for our clients products, which include- Labeling & Packaging of vials, prefilled syringes, autoinjectors - Serializiation (Track & Trace) - Quality Systems - Cold Chain up to - 80- ...
  • Product Foreign Particles

    Merieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentation combined with a pool of experts in different fields.Download our brochure: https://bit.ly/48HKnVs
  • Product Steriles

    We are your expert in sterile and aseptic manufacturing, where quality is paramount.
    Your most trusted partner for sterile and aseptic fill & finish:
    - Extensive knowledge and experience in process and analytical development
    - Unbeatable speed to market, without compromising on quality
    - ...
  • Product Pharmaceutical Contract Packaging

    Palladio Group can count on the decade-long experience of Pharma Partners, which offers two interconnected and separate divisions: Pharmaceutical Contract Packaging and consultancy.Pharmaceutical Contract Packaging is specialised in Serialisation and Track & Trace services (Reg. 161/2016). It is author...
  • Product Contract Development & Manufacturing Services (CDMO)

    With 70 years of experience in developing and manufacturing pharmaceutical products for diverse markets, we excel in Operational Excellence, Flexibility, and Adaptability.

    Salvat offers integrated CDMO services with state-of-the-art manufacturing facilities in Barcelona, Madrid, and Miami, equip...
  • Product Oncology


    Supporting oncology drug development from candidate selection through to commercial manufacture and supply
    In the past 5 years alone, Quotient has successfully worked on over 300 oncology development projects for 91 different oncology drug candidates spanning 34 different disea...
  • Product Exenatide Acetate

    Product Name: Exenatide Acetate;Cas No.141732-76-5;SequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2;Molecular FormulaC184H282N50O60S;Molar Mass4186.6 g/mol;Purity≥98%;Impurity≤0.5%...
  • Product Full-Service Pharmaceutical Manufacturing

    Thépenier Pharma & Cosmetics offers end-to-end manufacturing services for liquid and semi-solid pharmaceutical forms. With over 60 years of expertise, the company handles formulation, GMP-certified manufacturing, packaging, and regulatory compliance. Ideal for partners seeking reliable, eco-conscious p...
  • Product API Update Program

    Know the market with our API Update Program. Savendor has developed this program to give your sourcing team the data they need to make the best API sourcing decisions quickly. Savendor will gather pricing, Certificates of Analysis, lead time, and capacity info from the manufacturers of any API. This c...
  • Product Outsourcing

    Patheon by Thermo Fisher Scientific has a broad manufacturing platform for pharmaceutical and biologic products which provides sustainable solutions for mammalian cell-based and microbial-based manufacturing, green chemistry R&D and manufacturing technologies, and finished dosage production of biopharm...
  • Product C&ENjobs

    C&ENjobs has tailored digital and print recruitment products to better assist institutions and organizations looking to advance their recruitment campaigns. We are the only career center that allows employers to reach 176,000 ACS members and 31 million scientific researchers via multiple touchpoints. Start...
  • Product Progesterone Sustained Release 300mg Tablets - Pregaloop 300

    Bonds the Loop Between Mother and Child 
    Shree Venkatesh International Ltd offers a wide range of pharmaceutical products, including Progesterone Sustained Release 300 mg Tablets - Pregaloop 300.
    • Use: Used to treat progesterone deficiency in the body. It supplements your body with su...
  • Product Empagliflozin Tablets - Finempa

     Empagliflozin tablets lower blood sugar in type 2 diabetes by blocking SGLT2 in the kidneys, allowing excess glucose to be removed through urine.

    Indication - Empagliflozin tablets are primarily used to treat adults with type 2 diabetes mellitus. They help improve blood sugar co...
  • Product Excipients Formulation Development Support


    Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. Though excipients were at one time assumed to be “inactive” ingredients, it is now understood that excipients can have an important impact on the pharmaceutical...
  • Product Springs and Stamped & Bent Parts for Autoinjectors

    We manufacture precision components for 2- or 3-step auto-injectors that provide clear, audible, visual, and tactile feedback. The needle retracts after injection with the help of a spring, and the metal parts of the device are designed to cater to high- and low-viscosity drug delivery. The latest generati...
  • Product Regulatory Testing and Research based services for Pharmaceuticals, Chem...

    1) Analytical Testing Of Pharmaceuticals & Cosmetics2) Biotechnological Services
    3) Microbiological Services
    4) Bio - Compatibility Studies of Medical Devices(As per ISO 10993USFDA and MHLW Guideline)
    5) Preclinical & Toxicological Services
    6) Phytochemical & AYUSH Testing Se...
  • 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 Vaccine Characterization and Bioanalytical Support

    Our vaccines development experts provide a suite of services supporting the analysis and quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, lipi...
  • Product EVs extracellular vesicles characterization services

    Alfatestlab is equipped with the latest technology platform to provide rapid, reliable and accurate characterization of EVs following MISEV 2023 guidelines. Based on Nanoparticle Tracking Analysis (NTA - Nanosight) and Single-Vescicle Multiparametric Analysis (Leprechaun), our services for EVs of...
  • Product Nanoparticles

    Particle Engineering Technologies
    We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology we can support you from proof of concept to commercial manufacturing.

    Nanoparticles
    At Hovione we ...
  • Product Dosing systems - Liquid Dosing Device

    Medications can only be fully effective when dosed precisely and taken completely. Patients may develop resistance to an underdosage of antibiotics, for example. Overdosage can lead to drug poisoning.

    This means delivery of the exact effective dose plays a key role in the success of drug the...
  • Product Extractables & Leachables

    There are many contaminants that could be released inside a drug during the production process or by contact with the packaging material. Neotron Pharma will be able to support you from the study of Extractables, to the toxicological evaluation up to the control of the Leachables. What distinguishes us is ...
  • Product Bactocid

    Disinfectant Agent
  • Product Quality Control

    Our quality control department offers a broad range of services from incoming goods testing, in process controls to release of final product and stability testing. Our workflow ensures that all products are safe for market release and simultaneously functions as a feedback tool to help in the optimizat...
  • Product Characterization of Biologics and Biosimilars

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes characterization of biologics and biosimilars. It includes range of biologics such as: hormones and toxins, biosimilars (proteins and monoclonal antibodies), inn...
  • Product Process Development and Support Services

    Experic offers a consultative and collaborative approach to technical transfer, formulation, and process development based on a foundation of deep scientific knowledge, the ability to solve problems, and facilitate scale-up. Process development activities are augmented with expert technical project mana...
  • Product LINEAR MED

    High volume assembly platform for medical devices

    With its unique, modular design enabling easy fixture access from 3 sides, the LINEAR MED high-volume indexing platform is based on one-metre modules, allowing the chassis to be set up with 2, 3 or 4 sections. The platform is mostly...
  • Product TabTec CR

    TabTec CR is a single component solution with a patented child proof push/flip opening, TabTec CR has a sleek, appealing profile that makes it easy to slide discreetly into a back pocket. It comes in a variety of colours and tablet capacities and has comparable recyclability credentials to current plas...