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    Overview of API Custom Development & leading CMOs, CDMOs offering custom synthesis & contract manufacturing services for APIs & Intermediates.

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    Overview of API Custom Development & leading CMOs, CDMOs offering custom synthesis & contract manufacturing services for APIs & Intermediates.

    Q1. What is Custom API Development?

    An active pharmaceutical ingredient (API) is any substance or a mixture of substances used in a finished pharmaceutical drug product to provide pharmacological action. Custom API development refers to the production of desired quantities of APIs exclusively on a specified scale as per the customer's requirement.

    Drug substance development and manufacturing is the foundation on which pharmaceutical products are built. A company can use either a traditional approach or an enhanced approach to drug substance development, or a combination of both. The amounts produced during the synthesis of APIs tend to be small, ranging from a few milligrams to about 10 kilograms, and this can be carried out in-house or by manufacturers.

    Custom development is essential to the pharmaceutical industry as many active pharmaceutical ingredients (APIs) are sometimes very difficult to find or are hard to synthesize. Custom synthesis provides a platform to the clients to accelerate time to market for finished dosage forms (FDF).

    The requirements for complex chemicals to facilitate new innovations in drug development pose challenges for all drug development firms. The need for custom drug substance development and manufacturing in the pharmaceutical and biotechnology industries continues to expand.

    There are many active pharmaceutical ingredients (APIs), such as small molecule APIs, high potency APIs, small molecules, cytotoxic compounds, biological drug substances and large molecules such as peptides that require complex procedures for their synthesis. Companies prefer to outsource them to contract development and manufacturing organizations and contract manufacturing organizations.

    These pharmaceutical companies offer drug substance development services and custom API development and manufacturing along with pharmaceutical drug products. Custom drug substance development companies offer various services, including process and analytical validation, quality control and quality assurance, kilo scale, pilot scale and commercial production. Fully integrated contract development & manufacturing organizations offer drug substance manufacturing and enable the outsourcing of a broad variety of contract development activities from cytotoxic compounds, peptides, biological substance, small molecule drug substance manufacturing to the full scale clinical and commercial manufacturing.

    Q2. What are the steps involved in drug substance development and manufacturing?

    The API development process is a highly challenging task. There are several steps involved in API development and manufacturing and all of them have to be coordinated carefully.

    Steps involved in API development and manufacturing are noted below:

         
    • Route scouting: Synthetic route scouting during the early stages of process development provides significant benefits by reducing the processing time, decreasing the number of steps involved in process chemistry, improving the quality and safety profiles, reducing the production of chemical wastes and improving the scalability to accelerate the drug substance development and manufacturing process overall.
      •    
    • Process development: To combat the increasing complexity in API synthesis, the right process development method should be used from the lab scale to pilot scale.
      •    
    • Technology transfer: A proven technology transfer protocol is necessary. It ensures that the API manufacturer receives complete information about the chemistry, including all materials, processes and analytics.
      •    
    • Scale-up: Physicochemical studies, reactor treatments and purification are followed by scale-up. Scale up is generally defined as the process of increasing batch sizes. The early stage development phase, which is generally 100-1000 times smaller in quantity (milligrams) when compared to the production batch, takes place during the laboratory scale stage. A pilot plant is used to test the behavior of a product during small-scale API development and manufacturing, before proceeding with large-scale production. Pilot labs often use kilo lab units to achieve low volumes.
      •    
    • Process validation: Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, to establish scientific evidence that a process is capable of consistently producing a high-quality pharmaceutical product.
      •    
    • Commercial drug substance manufacturing: It can be very challenging to take Active Pharmaceutical Ingredients (APIs) from the preclinical stage to clinical development and then to commercial scale production. The final stage of scale-up (kilogram stage) is the production scale. Production batches are always referred to as the 100X batch and this is the scale at which drug substance manufacturing organizations run during routine product marketing.
      •    
    • Supply chain management

    Q3. What are the steps one should consider before undertaking active pharmaceutical ingredient (API) synthesis?

    Drug development begins with the synthesis of an API and preclinical research to determine the efficacy and safety of the drug. An active pharmaceutical ingredient (API) synthesis process is a related series of operations that results in the preparation of an active pharmaceutical ingredient. A significant part of the quality of the finished pharmaceutical product is dependent on the quality of the active pharmaceutical ingredients (APIs) used in the formulation.

    The key factors driving the growth of the active pharmaceutical ingredients (APIs) market are the increasing drug research and development activities for drug manufacturing, the growing importance of generics and the increasing number of biopharmaceuticals. The most important reason in favor of generics is the fact that they are far less expensive to manufacture than their branded counterparts.

    Contract Manufacturing Organizations (CMOs) have gained prominence amid the increasing cost of manufacturing drugs and the rise in chronic diseases. API suppliers who can secure their supply chains, from raw materials through to ingredients, are likely to see a considerable increase in demand from pharmaceutical firms.The trend of outsourcing work to CMOs by big pharmaceutical firms is expected to grow in the future, and this will result in a growth in demand for quality APIs.

    Proper profiling of your drug is the first step that you should consider before undertaking API synthesis. This includes considering its toxicology, which will have an impact on the facilities required and controls to be put in place to meet all safety and hygiene standards.

    The second step is to choose the route that will have the best efficiency. Before starting your experiments, you should first focus on important things like which reagents to use and how to make the process as efficient as possible.

    The third step involves preparing for scale-up, which includes at least three kilo scale-up trials of the process while still in the lab, before heading into the far more costly cGMP drug substance manufacturing facility for commercial processing. The last step involves developing a sound synthetic route process. While there are many things to consider and multiple steps to undertake in selecting a synthetic process for a drug candidate, the best CMOs focus on chemical yield, cycle time, number of chemical steps and convergence, etc.

    Q4. Which are the leading pharmaceutical companies offering API Development contract Services?

    There are various pharmaceutical organizations, such as contract pharmaceutical development and manufacturing organizations (CDMOs) that have the capabilities to offer active pharmaceutical ingredient development or API development services. The leading companies offering custom API development services are mentioned below.

    Ofichem - API Development Services

    With over 45 years of experience in the production of niche APIs, Laboratory Ofichem develops, produces & distributes APIs worldwide. It can safely & simultaneously produce a broad range of active pharmaceutical ingredients (APIs) for the human & veterinary pharmaceutical markets.

    Pfizer CentreOne - API Contract Manufacturing Services

    Pfizer CentreOne, a global API contract manufacturing and active pharma ingredient development organization, offers contract manufacturing services for intermediates, small molecules, large molecules and biological drug substances for clinical & commercial manufacturing.

    Minakem - HPAPI & API development services

    Minakem provides HPAPI development & API contract manufacturing services. Its facility in Louvain-la-Neuve pioneered the utilization of containment technology for the development of highly active pharmaceutical ingredients (HAPI) as well as cytotoxic compounds for clinical & commercial manufacturing.

    Polpharma - Active Pharmaceutical Ingredient Development Services

    Polpharma provides API contract manufacturing and development services for API synthesis & contract manufacturing services for FDFs. It has compliant and FDA-approved multipurpose facilities which offer an individual approach to each CDMO project.

    Phyton Biotech LLC - Plant-based drug substance development services

    Phyton offers comprehensive development and API contract manufacturing services for plant-based small molecules, extracts and recombinant products for use in traditional Chinese medicines (TCMs), cosmetics, agriculture as well as food & pharmaceutical industries.

    Solara Active Pharma Sciences - Custom API development services

    Solara offers contract research, manufacturing & active pharmaceutical ingredient development services across the entire value chain of a new chemical entity, from the preclinical phase to commercial production. It provides drug substance development services with custom active pharmaceutical ingredient (API) synthesis and API integration services.

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    Laboratorium Ofichem B.V

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    With over 45 years of experience in the production of niche APIs, Laboratory Ofichem develops, produces & distributes APIs worldwide. It can safely & simultaneously develop & produce a broad range of APIs for the human & veterinary pharmaceutical markets.

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    Polpharma

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    Polpharma API provides contract development and manufacturing services for APIs. It has cGMP compliant and FDA-approved multipurpose facilities which offers an individual approach to each CDMO project.

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    Pfizer CentreOne

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    Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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    CONTRACT API DEVELOPMENT & MANUFACTURING

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    Pfizer CentreOne, a global contract development and manufacturing organization (CDMO), offers API development and manufacturing services for small molecules, large molecule biologics, specialty APIs, intermediates, etc.

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    Contract API Development & Manufacturing

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    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    Minakem offers high-potency active pharma ingredient development & contract manufacturing services. Its facility in Louvain-la-Neuve pioneered the utilization of containment technology for the development of highly active pharmaceutical ingredients/HAPIs.

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    API & HPAPI Development Services

    CPhI North America

    Booth #1210

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    Phyton Biotech LLC

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    DEVELOPMENT OF PLANT-BASED MOLECULES

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    Phyton Biotech offers comprehensive development and contract manufacturing services for plant-based molecules, extracts and recombinant products used in traditional Chinese medicines (TCMs), cosmetics, agriculture, food and pharmaceutical industries.

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    Phyton Biotech Development of Plant-Based Molecules

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    LEBSA

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    API DEVELOPMENT SERVICES

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    Lebsa is a contract development and manufacturing organization (CDMO) that offers complete development of active pharmaceutical ingredients (APIs) including niche and small molecules to meet the growing demands of the pharmaceutical industry.

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    LEBSA API Development Services

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    Malladi Drugs & Pharmaceuticals Limited

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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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    DEVELOPMENT OF APIs & INTERMEDIATES

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    Malladi's R&D center has more than two decades of experience in API development and commercial production of various active pharmaceutical ingredients (APIs) and intermediates with commercialization of more than 200 products.

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    Malladi Drugs Development of APIs & Intermediates

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    Biophore India Pharmaceuticals Pvt Ltd

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    Research & innovation are the mainstay of Biophore’s operations. It is equipped with infrastructure that facilitates activities from conceptualization till regulatory approvals and lifecycle management for peptides and oncology products.

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    Biophore API Development Services

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    Inke S.A

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    Inke’s manufacturing plant specializes in the development of active pharmaceutical ingredients (APIs) with complex synthesis and extremely high GMP requirements.

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    Inke API Development Services

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    Century Pharmaceuticals

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    Virtual BoothCentury has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
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    Century Pharmaceuticals offers services for the development of new active pharmaceutical ingredients (APIs) and intermediates.

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    Century Pharmaceuticals API Development Services

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    Fermion Oy

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    DRUG SUBSTANCE DEVELOPMENT SERVICES

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    Fermion's contract development and manufacturing services cover the needs of customers from the clinical phase I stage until commercialization. It has extensive experience in NCE drug substance development and production since the 1990s.

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    Drug Substance Development Services

    CPhI North America

    Booth #1117

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    Aspen API

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    CDMO FOR API DEVELOPMENT

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    Aspen API has an extensive expertise in developing & manufacturing complex APIs and new products. It has 65 high quality APIs ranging from high potency, oncology, peptides, narcotics and analgesic with several new APIs under development.

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    CDMO for API Development

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    Tianjin Hankang Pharmaceutical Biotechnology

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      Tianjin Hankang Pharmaceutical Biotechnology is highly experienced in API, intermediate process, and quality development. It has a high-end production base in Jingmen, Hubeirich that produces active pharmaceutical ingredients.

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      Tianjin Hankang Pharmaceutical API Development Services

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      Extrovis AG

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        Extrovis is involved in the in-house development of critical or low-availability APIs to ensure long-term cost competitiveness and supply chain continuity. Its research centers operate at the heart of new and differentiated APIs, FDFs & intermediates.

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        Extrovis API Development

        Chinaplas 2024

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        Seqens

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        Seqens has more than 50 years of experience in developing and producing high-quality active pharmaceutical ingredients (APIs). It also offers CDMO services for niche molecules, lipids and polymers.

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        Aurigene Pharmaceutical Services

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        CUSTOM API DEVELOPMENT SERVICES

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        Aurigene Pharmaceutical Services offers custom chemical development of New Chemical Entity (NCE), Intermediates & RSM. It provides services from medicinal chemistry for preclinical studies, along with process development & optimization of lead candidates.

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        Aurigene Custom API Development Services

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        Neuland Laboratories

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        DRUG DEVELOPMENT SERVICES

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        Neuland is at the forefront of facilitating and accelerating drug development and cGMP manufacturing of APIs. The company’s technical and scientific teams provide reliable solutions and services to the global pharmaceutical industry.

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        Drug Development Services

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        Suanfarma CDMO

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          Suanfarma CDMO services run from preclinical supply up to commercial manufacturing, enabling it to support clients as they take molecules through development and onto the market, accommodating batch size requirements and ensuring capacity.

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          Suanfarma API Development Services

          CPhI China

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          SEQUENT SCIENTIFIC LTD

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          DEVELOPMENT OF HIGH-VALUE/LOW-VOLUME NICHE-COMPLEX APIs

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          Sequent has invested in facilities with an objective of creating an integrated, flexible unit capable of manufacturing several niche & complex APIs. The manufacturing facalities are capable of meeting the growing demand of our key products in the USFDA and WHO regulated markets.

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          Microchem SRL

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          MICRONIZATION

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          Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced,

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          Hameln rds

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          API DEVELOPMENT SERVICES

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          Hameln rds is a pharmaceutical service provider that offers several services, such as development and production of active pharmaceutical ingredients (APIs), tech transfer, regulatory affairs and quality control.

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          Eurofins CDMO

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          API DEVELOPMENT & CONTRACT MANUFACTURING

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          Eurofins CDMO provides API technology development services for the scale-up of complex small molecules with biotechnology and pharmaceutical applications including more potent APIs (HPAPIs) and cytotoxic compounds.

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          Recipharm AB

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          DRUG SUBSTANCE DEVELOPMENT & MANUFACTURING

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          Recipharm has more than 20 years of experience in drug substance development (API development) and manufacturing. It offers custom synthesis expertise in the development and manufacturing of active pharmaceutical ingredients (APIs).

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          Pierre Fabre

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          CDMO FOR SYNTHETIC ACTIVE INGREDIENTS

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          Pierre Fabre CDMO offers a complete service which covers the sourcing of raw materials and the industrial production of plant-based, animal-based or synthetic active ingredients, for the pharmaceutical, cosmetics and nutraceutical sectors.

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          Eurofins CDMO

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          API DEVELOPMENT & VALIDATION

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          Eurofins CDMO is experienced with the development & validation of several molecule API processes that are in various stages of regulatory approval across the globe. Their cGMP units are equipped with cryogenic, hydrogenation & chromatography capabilities.

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          Ocimum Labs

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            DRUG SUBSTANCE DEVELOPMENT & MANUFACTURING

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            Ocimum Labs offers various drug substance services, including chemical process development (pre-clinical to P-III/commercial), custom synthesis and commercial manufacturing with CMC support.

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            Angelini Pharma

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            API DEVELOPMENT SERVICES

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            The Fine Chemicals Division of Angelini is fully committed to supporting its pharmaceutical clients in their API development programs, providing dedicated personnel and tailor-made solutions to any challenge.

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            AXYNTIS Group

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            CDMO FOR APIs

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            Axyntis has CDMO capabilities for APIs complying with GMP, closely monitored by the quality insurance and regulatory affairs services such as laboratory, kilolab, pilot, industrial production & preparatory chromatography services.

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            Flamma SpA

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            R & D OF APIs

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            Our experienced process development chemists are an asset to our customers regardless of their size - virtual, small, mid-size, or large pharma/biotech. The scientists in the Flamma Italy R&D group and the Flamma Honkai R&D group provide optimal service to complete projects.

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            Solara Active Pharma Sciences

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            API DEVELOPMENT SERVICES

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            Solara offers contract research, manufacturing & development services for a new chemical entity from the pre-clinical to the commercial phase. It provides services for the development and manufacture of drug substances (active pharmaceutical ingredients).

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            Eurofins CDMO

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            FATE & PURGE SERVICES

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            Eurofins CDMO has strong experience in impurity control strategy from IND through to commercial stages and have demonstrated track-record in the design and execution of fate and purge studies.

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            BioSpectra

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            CUSTOM DEVELOPMENT & OPTIMIZATION

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            Biospectra provides custom API development with various aids like analytical development services, regulatory affairs support and other support services through a drug product's life cycle.

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            APC Ltd

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              PARTICLE DESIGN AND ENGINEERING

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              Delivering reliable and scalable crystallization processes through market leading capabilities and technologies in engineered API particle characterization.

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              Piramal Pharma Solutions

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              API DEVELOPMENT SERVICES

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              Piramal's Aurora, Canada, facility is a USFDA, Health Canada & PMDA inspected site which offers development as well as clinical and commercial GMP manufacturing of active pharmaceutical ingredients (APIs) for complex pharmaceutical NCEs.

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              Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                ASYMMETRIC AMINO ACIDS TRANSFORMATIONS BY DIAZOTATION

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                R&D center is located in High-tech park of Shanghai with area about 1,000 square meters. It is equipped with chemical synthesis room, formulation room and advanced instrument room. What’s more, there are 5 professionals focusing on new drug development.

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                Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                  CHIRAL SYNTHESIS

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                  R&D center is located in High-tech park of Shanghai with area about 1,000 square meters. It is equipped with chemical synthesis room, formulation room and advanced instrument room. What’s more, there are 5 professionals focusing on new drug development.

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                  Curia

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                  ACTIVE PHARMACEUTICAL INGREDIENT DEVELOPMENT

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                  Curia is a global contract research, development and manufacturing organisation (CDMO) known for the discovery and development of the active pharmaceutical ingredient (API) in Allegra.

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                  Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                    GRIGNARD REACTIONS & PROCESSES

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                    R&D center is located in High-tech park of Shanghai with area about 1,000 square meters. It is equipped with chemical synthesis room, formulation room and advanced instrument room. What’s more, there are 5 professionals focusing on new drug development.

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                    APC Ltd

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                      TERATOGENIC COMPOUNDS

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                      Dedicated laboratory and infrastructure addressing the needs of clients with highly potent synthetic molecules including containment solutions for beta-lactams.

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                      APC Ltd

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                        CONTAINMENT SOLUTION FOR BETA-LACTAMS

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                        Dedicated laboratory and infrastructure addressing the needs of clients with highly potent synthetic molecules including containment solutions for beta-lactams.

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                        Bioplus Life Sciences

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                        API DEVELOPMENT SERVICES

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                        BioPlus Life Sciences is a CDMO that offers active pharmaceutical ingredient (API) development services via synthetic organic chemistry, chiral chemistry, carbohydrate chemistry, etc.

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                        POLYPHARMA TECH & SCIENCES

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                          DEVELOPMENT OF GRANULATED APIs & EXCIPIENTS

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                          Polypharma offers a range of ’specialities’, which are less common such as materials whose physical characteristics have been modified (by micronisation or coating), microencapsulated materials (extended release), granulated APIs & excipients.

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                          Grace

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                            CHEMICAL DEVELOPMENT

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                            Grace's talented team of experts supported by a comprehensive cGMP environment, help customers in the pharmaceutical, nutraceutical, food and beverage, chemical processing, and other industries solve their most complex challenges.

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                            Vagdevi InnoScience

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                              SPECIALITY CHEMISTRY

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                              We offer a range of competitively priced chemistry services such as Medicinal Chemistry, Speciality Chemistry (Agro chemicals, Fine chemicals, Key starting Materials), Process Research & Development, Custom Synthesis, and Contract Research (FTE).

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                              V-Nano

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                                DEVELOPMENT OF CONVENTIONAL APIs

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                                V-Nano aims to become the European leader as CDMO for precision therapies. V-Nano manages the complete development of a wide range of APIs such as Cytotoxic or high potency API, Conventional API, Large & Small molecules.

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                                DrugOn Pharma Switzerland

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                                  API & INTERMEDIATE DEVELOPMENT

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                                  Drug’On Pharma was the last company to be set up in Orofino Pharmaceuticals Group. The CMO's chemical manufacturing sites, bought out from ex Knoll and Abbott in Switzerland, produce active pharmaceuticals ingredients - API and intermediates.

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                                  Ardena

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                                    API DEVELOPMENT SERVICES

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                                    Ardena provides comprehensive drug substance development services by supporting the entire workflow required to make the drug substance available for clinical studies and market authorization.

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                                    Provepharm Life Solutions

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                                    API DEVELOPMENT SERVICES

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                                    Provepharm has expertise in the chemical and pharmaceutical development of active substances and finished products based on peptides.

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                                    Huvepharma Italia S.r.l

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                                      COMPLETE DEVELOPMENT OF API

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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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                                      Pfanstiehl

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                                      DEVELOPMENT & MANUFACTURING OF API & HPAPI

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                                      Pfanstiehl is a global leader in the manufacture of cGMP-produced, high purity, injectable grade excipients and bioprocessing solutions.

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                                      Servier

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                                      OVERVIEW

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                                      Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs. Our full cGMP / FDAapproved chemistry network includes R&D, production and supply chain expertise with full regulatory support. Servier CDMO’s teams are able to follow your projects from

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