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    Looking for reference standards & impurity standards for APIs? Find a leading CMO, CDMO offering primary & secondary standards on PharmaCompass.

    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 Advinus Therapeutics Ltd (1)

    02 Almelo (1)

    03 Anacipher (2)

    04 Aozeal Certified Standards (1)

    05 Aragen Life Sciences (1)

    06 Bellen Chemistry (1)

    07 Bioindustria L.I.M. Spa (1)

    08 CLEARSYNTH LABS LIMITED (3)

    09 ChemCon GmbH (1)

    10 Chromcore Lifesciences (1)

    11 Cleanchem Laboratories (1)

    12 Dalton Pharma Services (2)

    13 Diverchim S.A. (1)

    14 Eurofins CDMO (1)

    15 Evotec (1)

    16 GRAM Laboratory Inc (1)

    17 Kekule Pharma (1)

    18 KriSan Biotech (1)

    19 Maithili Life Sciences (3)

    20 Prague Scientific (1)

    21 Priyans Drugs (1)

    22 Recipharm AB (1)

    23 SVAK Life Sciences (1)

    24 Sai Life Sciences Limited (1)

    25 Solara Active Pharma Sciences (1)

    26 TOPCHEM PHARMACEUTICALS (1)

    27 UQUIFA (1)

    28 USP (1)

    29 ZCL Chemicals Limited (1)

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    01 Canada (2)

    02 China (1)

    03 Czech Republic (1)

    04 France (2)

    05 Germany (2)

    06 India (18)

    07 Ireland (1)

    08 Italy (1)

    09 Singapore (1)

    10 Spain (1)

    11 Sweden (1)

    12 Taiwan (1)

    13 U.S.A (3)

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    USP

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      REFERENCE STANDARDS FOR APIs

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      USP offers primary standards to ensure quality in pharmaceutical development & manufacturing. USP reference standards are rigorously tested & evaluated by multiple independent laboratories including USP, commercial, regulatory & academic labs.

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      Pharma Service: API & Drug Product Development

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      Advinus Therapeutics Ltd

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        METABOLITE AND IMPURITY SYNTHESIS

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        Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

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        Maithili Life Sciences

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          SYNTHESIS & ISOLATION OF IMPURITIES

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          Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

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          Bioindustria L.I.M. Spa

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          DEGRADATION IMPURITIES

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          Bioindustria L.I.M's R&D laboratories are in charge of synthesizing process and degradation impurities for analytical purposes and to support customers in developing generics.

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          UQUIFA

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          IMPURITY PROFILE CHARACTERIZATION

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          Uquifa is a leading company for APIs and advanced intermediates offering capabilities including impurity profile characterization, stability studies, process validation and analytical method development services.

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          Solara Active Pharma Sciences

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          IMPURITY / REFERENCE STANDARD

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          Solara has a synthetic development team dedicated to impurity synthesis, with more than 800 compounds available. Their analytical services include impurity marker & reference standard preparation, qualification, management & distribution.

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          Maithili Life Sciences

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            IMPURITY, DEGRADANT OR METABOLITE ISOLATION

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            Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

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            TOPCHEM PHARMACEUTICALS

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            IMPURITIES, METABOLITES & RELATED MATERIALS

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            Topchem can supply impurity reference standards (IRS), metabolites and related research materials. Using their supply chain network they generally source advanced intermediates to facilitate rapid and cost effective supply of these materials.

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            Priyans Drugs

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              SYNTHESIS OF IMPURITIES & STANDARDS

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              Priyans Drugs headquartered in Singapore, is a professionally managed company supporting the pharmaceuticals business globally.

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              CLEARSYNTH LABS LIMITED

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                RELATED COMPOUNDS & POTENTIAL IMPURITIES

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                Clearsynth services are applied at all stages of development. Clearsynth considers all issues related to compounds and potential impurities.

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                Aozeal Certified Standards

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                  SYNTHESIS OF IMPURITIES & REFERENCE STANDARDS

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                  Aozeal Certified Standards (AOCS), Inc. is a high-tech biopharmaceutical company specialized in the custom synthesis & supply of API impurities & other pharmaceutical reference standards as per a customers’ desired purity, characterization & quantity.

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                  KriSan Biotech

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                    IMPURITY REFERENCE STANDARDS

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                    KriSan Biotech offers research and process development services to prepare impurity reference standards, active pharmaceutical ingredients (APIs) and intermediates.

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                    Eurofins CDMO

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                    IMPURITY SYNTHESIS

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                    Eurofins CDMO identifies, isolates & synthesizes process related impurities to support process development, analytical control & regulatory requirements. They offer services for the whole drug development process & manage impurities synthesis & control.

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                    Kekule Pharma

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                    IMPURITY SYNTHESIS

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                    Kekule Pharma offers various services including impurity synthesis, drug substance contract manufacturing, etc.They specialize in producing products through novel processes taking full advantage of their core competencies, equipment & facilities.

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                    Recipharm AB

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                    REFERENCE STANDARDS

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                    Recipharm's specialities include preparation of reference standards & internal standards with stable isotopes, synthesis of complex heterocycles, sugars, steroids, ADC linkers, phosphates, etc.

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                    ZCL Chemicals Limited

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                    SYNTHESIZING IMPURITIES

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                    ZCL's highly qualified professionals are working in drug product development, analytical development & IP rights. Its activities include route scouting, process development, scale up, technology transfer, synthesizing impurities, contract research, etc

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                    GRAM Laboratory Inc

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                      API REFERENCE STANDARD QUALIFICATION

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                      GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile and reference standard qualification.

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                      Maithili Life Sciences

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                        SYNTHESIS OF GMP IMPURITIES

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                        Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

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                        ChemCon GmbH

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                        SYNTHESIS OF REFERENCE STANDARDS

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                        ChemCon can synthesize and qualify reference standards as per client's needs. It combines the expertise and facilities of an analytical service provider with those of an experienced custom synthesis development and manufacturing organization (CDMO).

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                        Anacipher

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                          SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

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                          With the help of deep organic chemistry knowledge along with state-of-the-art synthesis infrastructure, Anacipher offers synthesis services for known / unknown impurities.

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                          Anacipher

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                            REFERENCE STANDARDS AND IMPURITIES

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                            Reference standards / working standards of impurities & products can be qualified & characterized with a complete report for regulatory submission. Anacipher helps in in-house impurity standard generation by means of degradation & isolation or synthesis.

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                            CLEARSYNTH LABS LIMITED

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                              REFERENCE STANDARDS

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                              Clearsynth's team of experienced scientists has expertise in the custom synthesis of a range of small molecules like APIs, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities, etc.

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                              Category: API Development

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                              CLEARSYNTH LABS LIMITED

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                                PHARMACEUTICAL IMPURITIES

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                                Clearsynth's team of experienced scientists has expertise in the custom synthesis of a range of small molecules like APIs, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities, etc.

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                                Prague Scientific

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                                NITROSAMINE IMPURITY SYNTHESIS & ANALYSIS

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                                Prague Scientific offers synthesis and analytical characterization of nitrosamine standards with confirmatory nitrosamine testing on the ppb/ppm level (analytical method development and validation).

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                                Sai Life Sciences Limited

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                                SYNTHESIS OF REFERENCE COMPOUNDS

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                                The key services offered by Sai Life Sciences include synthesis of reference compounds, lead generation and optimization, preparation of building blocks/key intermediates, metabolites, and impurity markers, etc.

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                                SVAK Life Sciences

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                                  IMPURITY REFERENCE STANDARD (IRS)

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                                  SVAK handles process development projects, cost reduction projects and impurity standards worldwide for a client base that includes pharmaceuticals, manufacturers of specialty chemicals, as well as universities and various other research institutions.

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                                  Cleanchem Laboratories

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                                    DEVELOPMENT OF IMPURITY REFERENCE STANDARDS

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                                    Cleanchem Laboratories is a contract research and manufacturing service provider that delivers impurity synthesis services. It also offers custom development of impurity reference standards, specialty chemicals, intermediates, metabolites, etc.

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                                    Bellen Chemistry

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                                      IMPURITY & REFERENCE STANDARD SYNTHESIS

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                                      Bellen's development service capabilities include synthesis of reference compounds, impurity markers, preparation of key intermediates, building blocks, design and synthesis of focused libraries, lead optimization and preclinical candidate selection, etc.

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                                      Almelo

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                                        IMPURITY SYNTHESIS

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                                        The Almelo Research Center (ARC) is a fully established facility for Almelo's in-house and custom product R&D services.

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                                        Evotec

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                                        IMPURITY / REFERENCE STANDARD

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                                        Evotec supports the key steps of the development of its partner’s APIs in route scouting & identification of a new route, custom synthesis, analytical method development & validation, synthesis of reference standards & impurities, etc.

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                                        Aragen Life Sciences

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                                        IMPURITY IDENTIFICATION, CHARACTERISATION & SYNTHESIS

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                                        GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customisation as per client’s need.

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                                        Chromcore Lifesciences

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                                          IMPURITIES TESTING

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                                          Chromcore provides various analytical testing services such as impurity testing, dose content uniformity for inhalation products such as dry-powder inhaler (DPI) & metered-dose inhaler (MDI), water or moisture content analysis, drug content (assay), etc.

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                                          Dalton Pharma Services

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                                            IMPURITY SCREENING

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                                            Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.

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                                            Pharma Service: API & Drug Product Development

                                            Category: API Development

                                            Sub Category: Impurity / Reference Standard
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                                            Diverchim S.A.

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                                            IMPURITY REFERENCE STANDARDS (IRS) SUPPLY

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                                            DIVERCHIM can supply its customer impurity reference standards, in response to health agencies’ requirements for impurity definition and characterization.

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                                            Pharma Service: API & Drug Product Development

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                                            Sub Category: Impurity / Reference Standard
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                                            Dalton Pharma Services

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                                              IMPURITY REFERENCE STANDARDS

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                                              Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.

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                                              Pharma Service: API & Drug Product Development

                                              Category: API Development

                                              Sub Category: Impurity / Reference Standard
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