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    The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change

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    01 Aizant Drug Research Solutions Pvt. Ltd. (1)

    02 Anacipher (1)

    03 Boston Analytical (1)

    04 Crenza Pharma (1)

    05 DPT Laboratories, Ltd (1)

    06 Doctor's Analytical Laboratories (1)

    07 GRAM Laboratory Inc (1)

    08 Megsan Labs Private Limited (1)

    09 Pace Analytical Services, LLC (1)

    10 Primera Analytical Solutions Corp (1)

    11 Quantex Laboratories (1)

    12 Sartorius Stedim Biotech (1)

    13 Solvias (1)

    14 Vitas Analytical Services (1)

    15 West pharma services (1)

    16 mKnal Global Solutions (1)

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    01 Germany (1)

    02 India (6)

    03 Norway (1)

    04 Switzerland (1)

    05 U.S.A (7)

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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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      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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        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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          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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            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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              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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                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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                  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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                  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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                  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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                  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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                    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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                      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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                      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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