LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise. LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise.

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    Mithra CDMO
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    Belgium
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    Rue de l’Expansion 57 4400 Flémalle
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    +32 (0)4 353 37 00
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    enquiries@pharmacompass.com
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    https://www.mithracdmo.com/
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    Mithra CDMO

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    COMMERCIAL MANUFACTURING FOR STERILE INJECTABLES

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    Our team combines expertise in drug development & formulation for generic applications or new chemical entities with an understanding of commercial contract manufacturing processes for long acting forms, sterile injectables and hormonal tablets.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Overview
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    FULL POLYMER CHARACTERIZATION BY DSC

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: DSC
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    FULL POLYMER CHARACTERIZATION BY RAMAN SPECTROSCOPY

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Raman
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    DRUG DISSOLUTION & DIFFUSION STUDIES

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Dissolution
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    PARTICLE SIZE DISTRIBUTION

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Particle Size
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    PRODUCT LIFE CYCLE SCALABILITY

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    Product life cycle scalability of formulations (early pilot studies, clinical trial materials, commercial batches), technical transferability are assured at all times thanks to a seamless collaboration between Mithra's development & manufacturing teams.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Scale-Up Capabilities
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    TECHNOLOGY TRANSFERS IN CLINICAL SUPPLY

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    Product life cycle scalability of formulations (early pilot studies, clinical trial materials, commercial batches), technical transferability are assured at all times thanks to a seamless collaboration between our development and manufacturing teams all on one site.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tech Transfer
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    DEVELOPMENT & VALIDATION OF DIFFUSION PROFILES

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    By Complying major guidelines and pharmacopeias (ICH, EMA, FDA, USP, EP), Our mission is to develop and validate reliable methods analytical methods for drug substances, excipients, drug products, raw materials and cleaning methods and diffusion profiles adapted to formulation.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    ICH Q3B COMPLIANT STABILITY OR FORCED DEGRADATION STUDI...

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    We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions, Which includes bulk holding time, Freeze/thaw studies, Informal, formal, accelerated and long-term stability conditions & ICH or custom conditions.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    UPLC H-CLASS WITH PDA DETECTOR

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    UV SPECTROPHOTOMETER

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: UV Spectrophotometry
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    GC-FID / HEADSPACE

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    The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

    - Directory Listing

    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    MICROBIOLOGICAL ANALYTICAL METHOD DEVELOPMENT & VALIDAT...

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    The microbiology laboratory offers a complete range of services from microbiological analytical method development and validation to routine testing for the product, raw materials and components release.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    WATER QUALIFICATION & ROUTINE TESTING

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    The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Pharmaceutical Water
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    BACTERIAL ENDOTOXIN TESTING

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    The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    CONTAINER CLOSURE INTEGRITY TESTING

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    The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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    Pharma Service: Analytical

    Category: Container Closure Integrity

    Sub Category: Assessment Programs
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    BIOLOGICAL INDICATOR TESTING

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    The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    MEDIA FILL SUPPORT & TESTING

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    The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    DRUG PRODUCT PHOTOSTABILITY STUDIES

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    We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability
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    PACKAGING STABILITY STUDIES

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    We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.

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    Pharma Service: Analytical

    Category: Packaging and Distribution Testing

    Sub Category: Shelf Life and Accelerated Aging Testing
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    PILOT BATCHES TO COMMERCIAL MANUFACTURING

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    With its new state-of the art facilities, Mithra CDMO is the flexible and cost-effective solution for your contract manufacturing needs from pilot batches to clinical trials materials, to full-scale commercial cGMP production.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Scale-Up Capabilities
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    cGMP CONTRACT MANUFACTURING OF LIQUID INJECTABLES

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    We provide cGMP manufacturing support in a comprehensive range of batch sizes for liquid injectables, long-acting products and oral forms.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Overview
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    cGMP CONTRACT MANUFACTURING OF TABLETS

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    We provide cGMP manufacturing support in a comprehensive range of batch sizes for liquid injectables, long-acting products and oral forms.

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    Pharma Service: Drug Product Manufacturing

    Category: Tablet

    Sub Category: Overview
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    cGMP CONTRACT MANUFACTURING OF CAPSULES

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    We provide cGMP manufacturing support in a comprehensive range of batch sizes for liquid injectables, long-acting products and oral forms.

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    Pharma Service: Drug Product Manufacturing

    Category: Capsule

    Sub Category: Overview
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    RELEASE TESTING OF INCOMING MATERIALS / FINISHED PRODUC...

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    Our mission is to support you in the compliance of your products by providing quality control analysis services as part of validation and release of production batches.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Batch Release and Stability Lot Testing
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    CLEANING VALIDATION SUPPORT & TESTING

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    Our mission is to support you in the compliance of your products by providing quality control analysis services as part of validation and release of production batches.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    PLURAL POLYMER TECHNOLOGY

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    Mithra has a strong heritage in Polymer Technology for long acting drug formulation & development. They have experience in developing multiple drug delivery strategies for drug / device combination products gained by successful preliminary development.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Controlled / Immediate / Modified Release
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    COMPATIBILITY TESTING API-EXCIPIENTS

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    Our team combines expertise in drug formulation development for generic applications or new chemical entities with an understanding of commercial pharmaceutical manufacturing processes for long acting forms, sterile injectables and hormonal tablets.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Excipient Screening
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    CLINICAL SUPPLY MANUFACTURING

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    Mithra offers tailored clinical manufacturing services to ensure a successful launch of your clinical trial: we develop your product according to your technical requirements within your timeframe.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Clinical Supply
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    COMMERCIAL MANUFACTURING FOR HORMONAL TABLETS

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    Our team combines expertise in drug formulation development for generic applications or new chemical entities with an understanding of commercial pharmaceutical manufacturing processes for long acting forms, sterile injectables and hormonal tablets.

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    Pharma Service: Drug Product Manufacturing

    Category: Tablet

    Sub Category: Overview
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    PACKAGING CAPABILITIES FOR CLINICAL TRIALS PRODUCTS

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    We offer tailored clinical manufacturing services to ensure a successful launch of your clinical trial. We develop your product according to your technical requirements within your timeframe.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Overview
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