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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 API Development

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    01 Advinus Therapeutics Ltd

    02 Almelo

    03 Anacipher

    04 Aozeal Certified Standards

    05 Aragen Life Sciences

    06 Bellen Chemistry

    07 Bioindustria L.I.M. Spa

    08 CLEARSYNTH LABS LIMITED

    09 ChemCon GmbH

    10 Chromcore Lifesciences

    11 Cleanchem Laboratories

    12 Dalton Pharma Services

    13 Diverchim S.A.

    14 Eurofins CDMO

    15 Evotec

    16 GRAM Laboratory Inc

    17 Kekule Pharma

    18 KriSan Biotech

    19 Maithili Life Sciences

    20 Prague Scientific

    21 Priyans Drugs

    22 Recipharm AB

    23 SVAK Life Sciences

    24 Sai Life Sciences Limited

    25 Solara Active Pharma Sciences

    26 TOPCHEM PHARMACEUTICALS

    27 UQUIFA

    28 USP

    29 ZCL Chemicals Limited

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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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    Pharma Service: API & Drug Product Development

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    Nitrosamine Impurity Synthesis & Analysis

    CPhI Japan

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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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      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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        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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          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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                    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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                      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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                        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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                              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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                                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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                                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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                                  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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                                    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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                                      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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                                        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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                                            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

                                            Category: API Development

                                            Sub Category: Impurity / Reference Standard
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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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