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    Overview of custom API manufacturing services, from pre-clinical & clinical manufacturing to commercial manufacturing, offered by CDMOs, CMOs, & CROs.

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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Overview of custom API manufacturing services, from pre-clinical & clinical manufacturing to commercial manufacturing, offered by CDMOs, CMOs, & CROs.

    Q1. What is custom API manufacturing?

    Custom API manufacturing refers to the production of desired quantities of pharma APIs, intermediates, fine chemicals, small molecules, reference standards, impurities, and other drug substances. API production is carried out exclusively according to a specified scale, which may include large scale custom API capabilities or commercial scale APIs.

    The amounts produced during drug substance custom manufacturing tend to be small, ranging from a few milligrams to about 10 kg or so, and can be carried out in-house or by contract active pharmaceutical ingredient manufacturers. An active pharmaceutical ingredient (API) is any substance or mixture of substances intended to be used as active ingredients in medicinal drug products. Active ingredients have direct effects in the diagnosis, cure, mitigation, treatment, and prevention of diseases.

    Pharma APIs and raw materials are often confused due to the similar usage of the two terms, however, raw materials refer to the chemical compounds used as a base for API production. The API production process is not completed in a single step, but rather via several chemical reactions between raw materials. The chemical compound which is in the process of becoming an API from a raw material is called an intermediate.

    Intermediates are the building blocks of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates are by-products of API synthesis. Furthermore, these pharmaceutical intermediates are produced during each and every reaction of API synthesis. The intermediates are then used in API production for bulk drugs and also for contract research and development (R&D) purposes by various pharma companies.

    Fully integrated contract development and manufacturing organizations offer cGMP API manufacturing services from small scale cGMP contract manufacturing of API to large scale custom API capabilities. Many of the CDMOs and CMOs offer small scale cGMP contract manufacturing of active pharmaceutical ingredients or custom synthesis of small molecules as a contract research project or as a custom synthesis project.

    The integrated cGMP API manufacturing services allow small scale cGMP contract manufacturing of APIs, from inception all the way through to clinical custom manufacturing and can even advance to production at a commercial scale. Custom API manufacturing or drug substance custom manufacturing ultimately provides the platform necessary for clients to accelerate time to market for finished dosage forms (FDF).

    Various pharmaceutical contract development organizations (CDMOs) can take projects from initial process development and scale-up through final validation and manufacturing at a commercial scale, by applying the appropriate drug manufacturing strategies and custom API manufacturing services. Custom API manufacturing services involve - Manufacturing of High Potent APIs (HPAPIs) or HPAPI custom synthesis, Key Starting Materials (KSMs), Registered Starting Materials (RSMs), key GMP intermediates, commercial scale APIs, etc.

    Q2. What are the different capabilities involved in drug substance or API custom manufacturing?

    Drug Manufacturing Strategies Involved in API Custom Manufacturing: 

    Step 1: Physicochemical Studies In this stage of API synthesis, the physicochemical properties of a drug substance are characterized and established. Every drug substance has intrinsic chemical and physical properties which need to be considered before latter drug manufacturing strategies can be conducted at a larger scale.

    Physicochemical studies include:

    - Selection of suitable drug substance candidates for API production
    - Planning API and drug substance custom development & manufacturing processes
    - Advancement of analytical development cGMP API manufacturing services
    - Assignment of pharma API retest periods
    - Synthetic route scouting custom API manufacturing services

     

    Route Scouting & Route Optimization:

    Synthetic route scouting, during early stages of process development and drug manufacturing, offers significant benefits by decreasing processing times, reducing the steps involved in process chemistry, improving quality and safety profiles, reducing chemical waste production, and improving scalability. 

    Route optimization can reduce costs, increase the efficiency of drug substance cGMP manufacturing, increase the safety of drug products, and accelerate the drug substance custom development and manufacturing process altogether. 

    Custom synthesis and route scouting go hand in hand, lately there has been an increasing trend towards achieving route optimization and all the benefits that the custom API manufacturing service imparts to the pharmaceutical product development process. Contract manufacturers provide such process chemistry, route scouting and route optimization - discovery and development services. 

     

    Step 2: Selection of Raw material: Active pharmaceutical ingredient (API) manufacturers take the raw materials, chosen during the early stages of drug substance development, and treat them in a reactor to obtain the required intermediates. 

    Step 3: Intermediates are purified to obtain individual drug products via sedimentation, filtration, centrifugation, crystallization, etc. 

    Step 4: Standards- The products that are obtained as a result are checked for their strength. Each pharmaceutical company employs different standards to measure the strength of its API.

    Step 5: Physicochemical studies, reactor treatments, and purification are followed by scale-up custom API manufacturing services. Scale up is generally defined as the process of increasing batch sizes. In process scale up, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacturing that affects the orderly transition from laboratory to routine processing of commercial scale APIs in a full-scale production CDMO facility. 

    Q3. What are the key features of cGMP API manufacturing?

    Good manufacturing practices (GMP) and to be GMP certified means that the active pharmaceutical ingredient (API) manufacturer has demonstrated a strong regulatory commitment compliant with international GMP standards. The jump to cGMP manufacturing is never simple, producing complex molecules within specification for the first time in cGMP is fraught with potential peril at every turn.

    API production has traditionally been done by pharmaceutical companies themselves in their home countries, but in recent years many corporations have opted to outsource manufacturing overseas to various CDMOs and CMOs. All the drug manufacturing strategies from selection of raw materials to commercial manufacturing of pharma APIs are performed under cGMP (current Good Manufacturing Practices) conditions.

    GMP is followed to ensure that pharmaceutical products (drug substances or drug products) are consistently produced and controlled according to quality standards and to minimize the risks involved in pharmaceutical production. Key elements of GMP API manufacturing must be clearly defined, agreed and controlled in order to avoid misunderstandings which could result in unsatisfactory products.

     

    Key Elements in GMP API Contract Manufacturing:

    - Quality Agreement
    - Adherence to manufacturing process
    - Supplier Audit
    - Release of manufactured product
    - Documentation and archive
    - Cleaning Validation
    - Change control

    Q4. What are the key attributes when performing cGMP scale up in custom API manufacturing?

    Drug substances are needed for a large number of safety studies and clinical trials. Custom synthesis and manufacturing services to go from preclinical to clinical manufacturing, and finally to commercial manufacturing can be challenging.

    It is essential that the drug substance manufacturing process, called scale up, is carried out to produce large quantities of active pharmaceutical ingredients. Additionally, when progressing a drug substance from milligram to kilogram scale, there are various characteristics of the drug substance that can impact formulation and need to be considered prior to implementing scale up.

    Pharmaceutical GMP scale-up deals with a subject vitally important to the industry—the procedures of transferring the results obtained via discovery and development services, from laboratory scale to the pharmaceutical pilot unit, and finally to production scale under GMP (Good Manufacturing Practices) conditions.


    Laboratory Scale: The early stage development phase, generally 100-1000 times lesser in quantity (milligrams) as compared to the production batch, takes place during the laboratory scale stage of formulation scale-up. 

    Pilot Plant: It is used to test the behavior of a product during small scale custom API development and manufacturing, before proceeding with large scale custom API capabilities at a commercial scale. Pilot labs often use kilo lab units to achieve low volume, test batches of active pharmaceutical ingredients.
    It is also an important stage for hazard identification and toxicity testing of drug products in a quality controlled testing laboratory. The pilot plant stage is where a lab scale formula is transformed into a viable product by using practical custom synthesis services and manufacturing procedures.

    GMP Production Scale: The last stage of scale-up (kilogram stage) is the production scale. Production batches are referred to as the 100X batch and this is the scale at which fully integrated contract research organizations, and more importantly contract development and manufacturing organizations, run during routine marketing of products.

    Fully integrated contract manufacturers, for API and molecule development, have the custom synthesis expertise to provide GMP scale up services at the laboratory and pilot scale of drug development.

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    Acharya Chemicals offers contract research, custom synthesis and manufacturing of active pharmaceutical ingredients (APIs), intermediates and specialty chemicals. It also handles the manufacture of products, from laboratory to plant scale.

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    PMC Isochem offers custom synthesis and manufacturing of active pharmaceutical ingredients (APIs), cGMP intermediates, and excipients such as Vitamin E TPGS and polyamino acids for drug delivery solutions.

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    Minakem offers contract development & manufacturing of APIs & highly potent APIs (HPAPIs). It's core capabilities include cGMP custom synthesis from kilo-lab to multi-ton scale, complex multi-step API process development and commercial manufacturing, etc.

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    Quotient Sciences provides drug substance synthesis and manufacturing capabilities, from candidate selection to commercial production.

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    Malladi offers the custom synthesis & manufacturing of a wide range of APIs & advanced intermediates. Its R&D center is well-equipped to handle processes including chiral synthesis, halogenation & amination for intermediate & API synthesis.

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    Cayman's chemists brings unmatched experience to solving difficult synthetic routes & performing complex, multistep syntheses & specialize in the production of eicosanoids (prostaglandins & leukotrienes), fatty acids, cannabinoids, & complex heterocycles.

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    Inke develops and manufacturers the highest quality of active pharmaceutical ingredients, mainly for use in respiratory and CNS therapies, with complex synthesis processes.

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    Axplora is a leading CDMO that offers custom manufacturing and synthesis of small molecule APIs, ADCs, and highly potent APIs from clinical supply to commercial manufacturing.

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    Polpharma API has cGMP compliant & FDA-approved multipurpose facilities that offer custom manufacturing and development services for active pharmaceutical ingredients. It offers clinical & commercial APIs from pilot plant to multi-ton manufacturing scale.

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    Custom API Manufacturing

    CPhI North America

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    EUROAPI

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    COMPLEX MULTI-STEP ORGANIC SYNTHESIS

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    EUROAPI is a CDMO for the synthesis of small molecules. It offers API development and multi-step organic synthesis by uniting the chemical expertise of Hoechst-Aventis, Roussel-Uclaf, Chinoin, Genzyme and Sanofi.

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    Pharma Service: API Manufacturing

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    Complex Multi-Step Organic Synthesis

    CPhI Japan

    Booth #5P-10

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    Inke S.A

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    API CUSTOM SYNTHESIS & MANUFACTURING

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    Inke develops and manufacturers the highest quality of active pharmaceutical ingredients (APIs), mainly for use in respiratory and CNS therapies, with complex synthesis processes.

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    Pharma Service: API Manufacturing

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    Inke API Custom Synthesis & Manufacturing

    Formulation & Delivery

    Attending

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    EUROAPI

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    MULTI-STEP SYNTHESIS OF SMALL MOLECULES

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    EUROAPI is a CDMO offering multi-step organic synthesis of small molecules. It has various capabilities like hydrogenation, alkylation, heterocyclic chemistry, solid- and liquid-phase chemistry for small and large volume API production (up to 1,000 tons).

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    Pharma Service: API Manufacturing

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    Multi-step Synthesis of Small Molecules

    CPhI Japan

    Booth #5P-10

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    EUROAPI

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    API ORGANIC SYNTHESIS

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    EUROAPI is a CDMO which offers API development services. It has six commercial facilities offering 2,000 m³ cGMP for organic synthesis and 6,000 m³ for microbial fermentation to produce small molecules.

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    Pharma Service: API Manufacturing

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    API Organic Synthesis

    CPhI Japan

    Booth #5P-10

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    EUROAPI

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    CDMO FOR ADVANCED ORGANIC SYNTHESIS

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    EUROAPI is a contract development & manufacturing organization (CDMO) for API development & organic synthesis. It has six commercial facilities, offering 2,000 m³ cGMP for organic synthesis & 6,000 m³ for microbial fermentation to produce small molecules.

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    Pharma Service: API Manufacturing

    Category: Custom Synthesis & Manufacturing

    Sub Category: Custom Synthesis

    CDMO for Advanced Organic Synthesis

    CPhI Japan

    Booth #5P-10

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    EUROAPI

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    CUSTOM API SYNTHESIS VIA FERMENTATION

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    EUROAPI offers custom API synthesis via microbial fermentation. It has six commercial facilities offering 2,000 m³ cGMP for organic synthesis and 6,000 m³ for microbial fermentation to produce small molecules.

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    Pharma Service: API Manufacturing

    Category: Custom Synthesis & Manufacturing

    Sub Category: Custom Synthesis

    Custom API Synthesis via Fermentation

    CPhI Japan

    Booth #5P-10

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    Maithili Life Sciences

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      CUSTOM SYNTHESIS OF APIs & INTERMEDIATES

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      Maithili undertakes custom synthesis of key intermediates and active drug substances for innovator companies worldwide. They have the expertise in synthesizing diverse classes of molecules and offer gram to ton scale-up in a cost-effective manner.

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      Arevipharma

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      CUSTOM API MANUFACTURING

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      Arevipharma help you overcome your lack of capacity and time by offering custom development and manufacturing services.

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      Procos

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      CLINICAL TO COMMERCIAL MANUFACTURING

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      Long-established contract manufacturing services. Comprehensive customer support, from early clinical stage up to commercial manufacturing. tailor-made offerings to meet customer-specific needs.

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      DOTTIKON EXCLUSIVE SYNTHESIS AG

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      CUSTOM SYNTHESIS AND PROCESS DEVELOPMENT

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      DOTTIKON provides chemical custom manufacturing services to scale up from grams to multi-tons, including routefinding, process design, process development, small-scale and pilot production, manufacturing, qualification and validation.

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      Priyans Drugs

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        CUSTOM MANUFACTURING

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

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        Kekule Pharma

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        CUSTOM MANUFACTURING FOR APIs

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        Kekule Pharma offers a wide range of services including API custom manufacturing, process development & scale up, GMP commercial manufacturing, etc. It has dedicated manufacturing facilities for oncology APIs & clean room facilities for synthetic APIs.

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        CTX Lifesciences

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        SYNTHETIC ROUTE SELECTION

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        CTX Life Sciences focusses to develop and manufacture active pharmaceutical ingredients (APIs) and intermediates for global supply, complying with quality and regulatory requirements of our customers

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        TOPCHEM PHARMACEUTICALS

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        PROVEN TRACK RECORD IN DESIGNING NEW SYNTHESES

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        Topchem Pharmaceuticals has an extensive and proven track record in designing new syntheses, combining high creativity with a sound commercial focus, and developing these processes up to full scale tonnage pharmaceutical production.

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        ChemCon GmbH

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        API CUSTOM SYNTHESIS & MANUFACTURING

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        ChemCon is a contract development and manufacturing organization (CDMO) for pharmaceutical ingredients and fine chemicals. It has over 20 years of experience in the synthesis of chemical substances as high-quality fine chemicals and GMP-compliant APIs.

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        CRMO Pharmmatecch

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          CUSTOM MANUFACTURING PROJECT EXECUTION

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          CRMO Pharmmatecch will ensure execution of the entire custom-manufacturing project on behalf of the customer.

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          BioSpectra

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          CUSTOM - CONTRACT MANUFACTURING

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          BioSpectra offers custom manufacturing of both solids and solutions, meeting your desired compliance standards and specifications, up to and including, APIs and Excipients requiring ICH Q7 GMP Compliance.

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          Robinson Brothers

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            CUSTOM SYNTHESIS FOR API MANUFACTURING

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            Here at Robinson Brothers, we can further rapidly scale processes and products as necessary from laboratory grams to kilograms in our Kilo-Laboratory and/or Pilot Plant facilities and thence in an Operations Plant to manufacture multi-tonne quantities.

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            Maithili Life Sciences

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              DEVELOP NEW SYNTHESIS ROUTES

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              Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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              Pharma Service: API Manufacturing

              Category: Custom Synthesis & Manufacturing

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              ScinoPharm Taiwan, Ltd

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              CUSTOM SYNTHESIS FOR EARLY PHASE

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              Supply of gram quantities for use as building blocks, drug screening, purity standards, etc. ScinoPharm can undertake cGMP manufacturing, including pre-clinical and clinical manufacturing, as well as launch and post-launch supply requirements.

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              Infinium Pharmachem

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                CUSTOM SYNTHESIS OF BULK ACTIVES

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                We offer Bulk Actives, Intermediates and services for Custom Synthesis providing an integrated solution for the diverse requirements of generic and innovator companies in Iodine Chemistry.

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                Shanghai Chemspec Corporation

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                CUSTOM SYNTHESIS OF PHARMACEUTICAL INTERMEDIATES & APIs

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                Chemspec conducts research studies for pharmaceutical chemicals, including custom synthesis and process development of pharmaceutical intermediates and APIs and also research studies for liquid crystal.

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                Pharma Service: API Manufacturing

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                Maithili Life Sciences

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                  MULTI-STEP SYNTHESIS

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                  Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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                  Pharma Service: API Manufacturing

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                  Maithili Life Sciences

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                    SYNTHESIS OF SMALL FUNCTIONALISED MOLECULES

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                    Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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                    Pharma Service: API Manufacturing

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                    Merck Millipore

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                      CUSTOMIZED FORMULATION

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                      With our wide range of functional products, we support you, whether for ethical products, OTC products or line extensions, in finding the optimal formulation. Thanks to our global presence, we'll help you to ensure smooth upscaling to production.

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                      Pharma Service: API Manufacturing

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                      Solara Active Pharma Sciences

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                      CUSTOM SYNTHESIS AND MANUFACTURING

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                      Solara, the API and CRAMS provider offers custom synthesis and API development, custom synthesis - API & molecule development, custom organic synthesis, process development in a regulatory compliant area using DOE, from mg to metric ton scale.

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                      Pharma Service: API Manufacturing

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                      Sub Category: Custom Synthesis
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                      Maithili Life Sciences

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                        SYNTHESIS OF SMALL FOCUSED LIBRARIES

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                        Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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                        Aozeal Certified Standards

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                          CUSTOM ORGANIC SYNTHESIS & BIOSYNTHESIS

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                          Aozeal Certified Standards (AOCS), Inc. is a high-tech bio-pharmaceutical company with its own research lab equipped with advanced technology and a smart team for organic synthesis and biosynthesis.

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                          DOTTIKON EXCLUSIVE SYNTHESIS AG

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                          NINE cGMP MULTI-TON PRODUCTION PLANTS

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                          DOTTIKON EXCLUSIVE SYNTHESIS AG has nine cGMP multipurpose and specialized multi-ton production plants including hazardous reactions, high-pressure (50 bar), low-temperature ( 100°C), and continuous processing.

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                          Maithili Life Sciences

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                            SYNTHESIS OF BUILDING BLOCKS

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                            Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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                            Chemtos

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                              CUSTOM SYNTHESIS FOR API MANUFACTURING

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                              We specialize in small-scale synthesis of: APIs, Metabolites, Impurities, Analogues, Intermediates

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                              Pharma Service: API Manufacturing

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                              Angelini Pharma

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                              API CUSTOM SYNTHESIS & MANUFACTURING

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                              Angelini has API synthesis unit with a well-established track record of custom synthesis (2-5 new products or projects developed each year). Angelini’s manufacturing chemists have the skills and experience to meet a range of pharma outsourcing services.

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                              ScinoPharm Taiwan, Ltd

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                              NEW SYNTHETIC ROUTES DEVELOPMENT

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                              ScinoPharm possesses a full range of chemistry capabilities & has extensive experience in synthesizing complex molecules. Depending on requirements, we develop new synthetic routes, or scale up & optimize processes based on the customer’s technology.

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                              Recipharm AB

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                              ROUTE SCOUTING

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                              Recipharm also performs route scouting & process development and can verify a process at 20 L scale to manufacture material suitable for toxicology studies in our development facilities. They can also offer further scale-up services and GMP-manufacturing.

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                              Aozeal Certified Standards

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                                CUSTOM ORGANIC SYNTHESIS

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                                Aozeal Certified Standards (AOCS), Inc. has a proven track record for delivering custom synthesis projects and the research lab is equipped with advanced technology and smart team for organic synthesis and biosynthesis.

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                                Menadiona

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                                CUSTOM SYNTHESIS OF APIs

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                                Menadiona offers custom & contract manufacturing services through their fine chemical division. They specialize in manufacturing active ingredients (APIs) & key intermediates for the pharmaceutical, veterinary, plant health and nutraceutical industries.

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                                Pharma Service: API Manufacturing

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                                Arevipharma

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                                CUSTOM MANUFACTURING OF GENERIC & INNOVATIVE APIs

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                                Exclusive custom manufacturing of generic and innovative APIs, as well as of other specialty chemicals.

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                                Pharma Service: API Manufacturing

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                                Merck Millipore

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                                  API SYNTHESIS

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                                  Our active pharmaceutical ingredient (API)-related portfolio includes folates and custom synthesis, as well as our EMPROVE® api product family. Furthermore we offer activated PEGs that are used for drug conjugation.

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                                  Pharma Service: API Manufacturing

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                                  Anacipher

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                                    API CUSTOM SYNTHESIS

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                                    Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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                                    Anacipher

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                                      NON-INFRINGING SYNTHETIC ROUTES

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                                      Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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                                      Pharma Service: API Manufacturing

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                                      Curia

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                                      CUSTOM SYNTHESIS AND MANUFACTURING

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                                      Curia provides API custom synthesis and contract manufacturing services on small and large scales during all phases of discovery, development and manufacturing.

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                                      Pharma Service: API Manufacturing

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                                      Stason Pharmaceuticals, Inc.

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                                      CUSTOM MANUFACTURING

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                                      Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

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                                      ChemGenix Laboratories Pvt Ltd

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                                        CUSTOM MANUFACTURING

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                                        ChemGenix offers full range of custom designed manufacturing services to their customers.

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                                        Pfanstiehl

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                                        CUSTOM SYNTHESIS OF ACTIVE PHARMACEUTICAL INGREDIENTS

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                                        With over 50 years experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.

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                                        Servier

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                                        CUSTOM SYNTHESIS OF PHARMACEUTICAL IMPURITIES

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                                        Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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                                        Olon S.p.A

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                                        CUSTOM SYNTHESIS FOR API MANUFACTURING

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                                        Olon S.p.A, has always been at the flank of the largest Multinationals of the pharmaceutical industry producing for them very advanced intermediates as well as APIs principles on an exclusive basis. About 40% of Olon’ sales turnover comes from API contract manufacturing activities.

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                                        Stason Pharmaceuticals, Inc.

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                                        API SYNTHESIS

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                                        Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

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                                        ChemGenix Laboratories Pvt Ltd

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                                          COMPLEX MULTI-STEP ORGANIC SYNTHESIS

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                                          ChemGenix offers full range of custom designed manufacturing services to their customers.

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                                          CPL Sachse

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                                            CUSTOM SYNTHESIS & MANUFACTURING

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                                            In addition to GMP manufacturing capabilities, CPL Sachse offers the production of high-quality material for preclinical or toxicological studies as well as reference and impurity standards.

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                                            ChemGenix Laboratories Pvt Ltd

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                                              INORGANIC CUSTOM SYNTHESIS

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                                              ChemGenix offers full range of custom designed manufacturing services to their customers.

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                                              Siegfried AG

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                                              PRODUCTION OF CUSTOMIZED APIs

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                                              Siegfried’s chemical expertise centers on the development and production of active pharmaceutical ingredients and intermediates, thus making Siegfried the ideal partner for both cGMP and non-cGMP active pharmaceutical ingredients and intermediates.

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                                              Quality Chemicals

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                                              CUSTOM PURIFICATION & SYNTHESIS

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                                              Quality Chemicals offers custom purification & synthesis for various products. They can customise products such as reagents, inorganic salts, organic salts, solvents, solutions and mixtures.

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                                              Diverchim S.A.

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                                              ROUTE SCOUTING TO FULL PROCESS DEVELOPMENT & MANUFACTUR...

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                                              From route scouting to full process development, DIVERCHIM provides to its customers a robust, reproductible and cost-effective manufacturing process.

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                                              Pharma Service: API Manufacturing

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                                              ChemGenix Laboratories Pvt Ltd

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                                                EMULSION OR SOLUTION POLYMERIZATION SYNTHESIS

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                                                ChemGenix offers full range of custom designed manufacturing services to their customers.

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                                                ChemGenix Laboratories Pvt Ltd

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                                                  ELECTRONIC CHEMICALS SYNTHESIS

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                                                  ChemGenix offers full range of custom designed manufacturing services to their customers.

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                                                  Huvepharma Italia S.r.l

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                                                    CUSTOM SYNTHESIS AND MANUFACTURING

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                                                    Huvepharma® Italia is a recognized as a reliable supplier of development and manufacturing services of APIs & advanced intermediates for leaders in the international market.

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                                                    Dalton Pharma Services

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                                                      GMP FRIENDLY ALTERNATIVE SYNTHETIC ROUTES DEVELOPMENT

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                                                      Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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                                                      Dalton Pharma Services

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                                                        IP PROTECTED SYNTHETIC ROUTES DEVELOPMENT

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                                                        Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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                                                        Legacy Pharmaceuticals Switzerland

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                                                          CUSTOMIZED MANUFACTURING SOLUTIONS

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                                                          Benefit from Legacy Pharmaceutical's GMP standards and expertise in the development and management of production processes and production environments in the production of pharmaceuticals and active ingredients.

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                                                          Olon S.p.A

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                                                          DEVELOPMENT OF SYNTHETIC ROUTE OF NEW CHEMICAL ENTITIES

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                                                          Olon's R&D expertise extends over a wide range of areas. It includes: development of synthetic route of new chemical entities; production of GMP material for clinical supply; process improvement activities.

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                                                          Siegfried AG

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                                                          DEVELOPMENT OF ENTIRELY NEW SYNTHETIC ROUTES

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                                                          Our talented and innovative development chemists are well experienced either in the development of entirely new synthetic routes or adapting and optimizing an existing process (from Siegfried or our customers).

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                                                          Cambrex Corporation

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                                                          cGMP API CUSTOM MANUFACTURING

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                                                          With quality, innovation and flexibility, we offer pharmaceutical custom manufacturing excellence. Our extensive small molecule API custom manufacturing capabilities takes your project from early phase development to scale-up & commercial manufacture.

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