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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.

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    01 Container Qualification

    02 Container Qualification

    03 Extractables and Leachables

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    01 Aizant Drug Research Solutions Pvt. Ltd.

    02 Anacipher

    03 Aragen Life Sciences

    04 Boston Analytical

    05 Crenza Pharma

    06 DPT Laboratories, Ltd

    07 Doctor's Analytical Laboratories

    08 GRAM Laboratory Inc

    09 Megsan Labs Private Limited

    10 Pace Analytical Services, LLC

    11 Primera Analytical Solutions Corp

    12 Quantex Laboratories

    13 Renejix

    14 Sartorius Stedim Biotech

    15 Siegfried AG

    16 Solvias

    17 Stason Pharmaceuticals, Inc.

    18 Vitas Analytical Services

    19 West pharma services

    20 mKnal Global Solutions

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    03 Norway

    04 Switzerland

    05 U.S.A

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    Renejix

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      CONTAINER TESTING

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      Renejix CDMO offers analytical services such as container testing, container performance qualification, and pharmaceutical glass analysis.

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      Pharma Service: Analytical

      Category: Container Qualification

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      Container Testing

      Chinaplas 2024

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      West pharma services

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      EXTRACTABLES & LEACHABLES TESTING FOR DELIVERY SYSTEMS

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      West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.

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      Pharma Service: Analytical

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      Primera Analytical Solutions Corp

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      ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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      Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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      Pharma Service: Analytical

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      mKnal Global Solutions

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        EXTRACTABLE & LEACHABLE STUDIES

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        Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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        Pharma Service: Analytical

        Category: Extractables and Leachables

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        Quantex Laboratories

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          ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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          Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.

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          Pharma Service: Analytical

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          Vitas Analytical Services

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            ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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            Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.

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            Pharma Service: Analytical

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            Crenza Pharma

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              EXTRACTABLE & LEACHABLE STUDY

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              Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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              Pharma Service: Analytical

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              Anacipher

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                EXTRACTABLE & LEACHABLES

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                Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.

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                Pharma Service: Analytical

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                Boston Analytical

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                  EXTRACTABLES & LEACHABLES ANALYSIS

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                  Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

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                  Pharma Service: Analytical

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                  GRAM Laboratory Inc

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                    EXTRACTABLES & LEACHABLES STUDY

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                    GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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                    Pharma Service: Analytical

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                    Aizant Drug Research Solutions Pvt. Ltd.

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                    LEACHABLES & EXTRACTABLES STUDIES

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                    Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

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                    Pharma Service: Analytical

                    Category: Extractables and Leachables

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                    Solvias

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                    EXTRACTABLE & LEACHABLE TESTING SERVICES

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                    Solvias provides expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceuticals by providing customizable workflow for quantitative extractables studies.

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                    Pharma Service: Analytical

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                    DPT Laboratories, Ltd

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                    EXTRACTABLE & LEACHABLES

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                    DPT’s provides reliable and accurate analytical testing services for Extractable & Leachables.

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                    Pharma Service: Analytical

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                    Pace Analytical Services, LLC

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                      EXTRACTABLE & LEACHABLE TESTING

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                      With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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                      Pharma Service: Analytical

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                      Megsan Labs Private Limited

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                      EXTRACTABLE & LEACHABLE STUDIES

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                      Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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                      Pharma Service: Analytical

                      Category: Extractables and Leachables

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                      Sartorius Stedim Biotech

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                        EXTRACTABLES & LEACHABLES TESTING SERVICES

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                        Sartorius offers unique expertise in the field of extractables & leachables, such as extractables evaluation, extractables & safety assessments, E&L long-term/storage studies for different container materials, leachables screening, etc.

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                        Pharma Service: Analytical

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                        Doctor's Analytical Laboratories

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                          EXTRACTABLE & LEACHABLES TESTING SERVICES

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                          DALPL's current services at the pharma division include extractable & leachables as per FDA guidelines & PQRI suggestions, genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities by ICP MS, etc.

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                          Stason Pharmaceuticals, Inc.

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                          CONTAINER-API INTERACTIONS

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                          Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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                          Pharma Service: Analytical

                          Category: Container Qualification

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                          Siegfried AG

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                          PACKAGING SCREENING FOR UP-FRONT STABILITY

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                          Based on more than 30 years of experience and application with an extensive range and type of products, our customers gain more knowledge, Innovation and technological expertise through the following services: Packaging screening for up-front stability.

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                          Aragen Life Sciences

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                          INTERACTIONS WITH PACKAGING MATERIALS

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                          GVK BIO performs stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.

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