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    Pharma Services Category of Ash Stevens, Inc.

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 API Development (3)

    02 Analytical Method Development (3)

    03 Analytical Testing Services (5)

    04 Contract Manufacturing (1)

    05 High Potency APIs (HPAPIs) (1)

    06 Stability Studies (1)

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    01 Ash Stevens, Inc. (14)

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    01 U.S.A (14)

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    Ash Stevens, Inc.

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    PROCESS RESEARCH, DEVELOPMENT & OPTIMIZATION

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    Process development and route optimization are core competencies at Ash Stevens. Our company has a dedicated staff of professional process chemists and engineers with substantial experience and expertise in the development of robust cGMP chemical processes.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    Ash Stevens, Inc.

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    PROCESS SAFETY / HAZARD ASSESSMENT

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    Process development and route optimization are core competencies at Ash Stevens. Our company has a dedicated staff of professional process chemists and engineers with substantial experience and expertise in the development of robust cGMP chemical processes.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Safety Assessment
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    Ash Stevens, Inc.

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    LABORATORY & PILOT PROCESS SCALE-UP

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    Process development and route optimization are core competencies at Ash Stevens. Our company has a dedicated staff of professional process chemists and engineers with substantial experience and expertise in the development of robust cGMP chemical processes.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    API MANUFACTURING

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    Ash Stevens has a longstanding track record & reputation as a preferred supplier of innovator APIs. We are a fully integrated pharmaceutical contract manufacturer supporting all aspects of drug substance development & manufacturing, from early-stage development to commercial API production.

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    Pharma Service: API Manufacturing

    Category: Contract Manufacturing

    Sub Category: Overview
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    Ash Stevens, Inc.

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    HIGH POTENCY APIs (HPAPIs)

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    Ash Stevens is a leader in the development and cGMP manufacture of high potency active pharmaceutical ingredients (HPAPIs).

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    Pharma Service: API Manufacturing

    Category: High Potency APIs (HPAPIs)

    Sub Category: Overview
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    METHODS DEVELOPMENT & METHODS VALIDATION

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    Ash Stevens, Inc.

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    SPECIFICATION DEVELOPMENT & MATERIAL TESTING

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Overview
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    STRUCTURAL ANALYSIS

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Structure Elucidation
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    IMPURITY ISOLATION & IDENTIFICATION (INCLUDING GTIS)

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    Ash Stevens, Inc.

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    PRODUCT CHARACTERIZATION & PURITY ASSESSMENT

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    Ash Stevens, Inc.

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    API SOLIDS CHARACTERIZATION

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Physical Characterization
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    TEST & RELEASE OF STARTING MATERIALS & FINAL PRODUCTS

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Batch Release and Stability Lot Testing
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    Ash Stevens, Inc.

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    ICH STABILITY STUDIES

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    Ash Stevens, Inc.

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    REFERENCE STANDARD QUALIFICATION AND MAINTENANCE

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    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Reference Substances / Qualification
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