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    Overview of GMP contract manufacturing of APIs, from clinical production to commercial manufacturing, by contract manufacturing organizations (CMO).

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    Overview of GMP contract manufacturing of APIs, from clinical production to commercial manufacturing, by contract manufacturing organizations (CMO).

    Q1. What is API contract manufacturing?

    Contract manufacturing pertains to outsourcing a part or the entirety of the drug manufacturing process of a product, which was likely performed in house, to a third-party contract manufacturer. Nowadays, outsourcing activities like the design, production, assembly, and distribution of products to contract manufacturers has become commonplace in the pharmaceutical industry.

    Contract manufacturing is beneficial for customers as it provides them a guaranteed supply of drug products from clinical production to commercial manufacturing under integrated cGMP and pre-GMP manufacturing operations. Furthermore, it enables companies to focus on selling and marketing products instead of focussing on the drug manufacturing process itself.

    Pharmaceutical contract manufacturing organizations including CMOs and CDMOs can provide such contract manufacturing and analysis services. At times, pharmaceutical contract manufacturing organizations can be specialized in custom synthesis or API synthesis, chemical synthesis of small molecules, and custom API manufacturing services. 

    - Custom Synthesis of Small Molecules: Small molecules are low molecular weight molecules that include lipids, monosaccharides, secondary messengers, other natural products and metabolites, as well as pharmaceutical drugs and other xenobiotics. Custom synthesis of small molecules refers to the production of such low weight molecules. 

     

    An API or an active pharmaceutical ingredient is any substance or mixture of substances intended to be used as active ingredients in medicinal drug products. Custom API manufacturing services refer to the production of desired quantities of pharma APIs, intermediates, fine chemicals, reference standards, impurities, and other drug substances under GMP (Good Manufacturing Practices) guidelines.

    Active pharmaceutical ingredient (API) production is carried out exclusively according to a specified scale, which may include commercial scale APIs. Moreover, API manufacturing includes the chemical synthesis of niche APIs. Niche APIs are active ingredients for drug products that are needed in the world but are not produced on a large scale due to the small size of the market. Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

     

    Custom API manufacturing services may also include physicochemical studies, route scouting, route optimization, purification, scale up, and process development, amongst other drug manufacturing capabilities. Recently, increased outsourcing to CMOs and CDMOs has been observed in small to large biotech and pharma companies, for early to late-stage API development and manufacturing projects.

    While some companies are still hesitant to outsource their API production activities to contract manufacturers or active pharmaceutical ingredient (API) manufacturers, due to data security and quality concerns, the benefits of contract manufacturing outweigh the costs. In the coming years more firms are likely to join the trend of outsourcing drug manufacturing processes to contract manufacturers. 

    Finally, as a significant part of the quality of a finished pharmaceutical product (FPP) is dependent on the quality of the active pharmaceutical ingredients (APIs), it is important for companies (in-house and contract manufacturers) to adopt outlined strategies and comply with regulations imposed on the development and manufacturing of APIs. 

    Q2. What is an API and what are the differences between APIs, raw materials and intermediates?

    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 (API starting 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 (also known as API starting materials) and pharmaceutical intermediates are by-products of the chemical synthesis of APIs (API synthesis).

    Furthermore, these pharmaceutical intermediates are produced during each and every reaction of custom synthesis or API synthesis. The intermediates are then used in API production for bulk drug substances and also for contract research and development (R&D) purposes by various pharma companies.

    Q3. What is GMP contract manufacturing?

    In the context of globalization, pharma APIs are sourced in a worldwide market and the risk of sourcing substandard or contaminated products is high. A proper system of regulation for contract manufacture and analysis service providers can promote the constant sourcing of active pharmaceutical ingredients (API) of appropriate quality, thereby safeguarding public health interests.

    As mentioned above, contract GMP manufacturing service providers and GMP certified manufacturers take an integrated cGMP and pre-GMP manufacturing operations approach to fulfill their contractual assignments. Good Manufacturing Practices (GMP), is a system for ensuring that products are consistently produced and controlled according to quality standards, from clinical production to commercial manufacturing. It is designed to minimize the risks involved in pharmaceutical drug manufacturing that cannot be eliminated through testing the final product. 

    GMP may also be referred to as cGMP in which the “c” stands for current, and roughly translates to current Good Manufacturing Practices. This is an important distinction as guidelines for cGMP contract manufacturing of active pharmaceutical ingredients are constantly evolving and only the most up-to-date system ensures the quality of the end product that reaches the consumers. GMP manufacturing guidelines are outlined and assessed by regulatory agencies like the FDA and ICH. 

    A GMP certified active pharmaceutical ingredient (API) manufacturer is a production firm that demonstrates a strong regulatory commitment to cGMP contract manufacturing of active pharmaceutical ingredients, compliant with international GMP standards. The jump to cGMP manufacturing is never simple for GMP certified manufacturers, producing complex molecules within specification for the first time in cGMP is fraught with potential peril at every turn.

    Moreover, key elements of cGMP API manufacturing must be clearly defined, agreed to and controlled by GMP certified manufacturers in order to avoid misunderstandings which could result in unsatisfactory custom synthesis products. Some of the main aspects of cGMP contract manufacturing of active pharmaceutical ingredients or cGMP API manufacturing are enumerated below:

     

    - Quality Management: Principles & Responsibility 

    - Personnel: Qualifications & Hygiene

    - Building & Facility: Design, Utility & Sanitation

    - Process Equipment: Design, Calibration & Maintenance

    - Documentation & Records

    - Materials Management 

    - Production & In-process Controls 

    - Packaging and labeling of pharma APIs & Intermediates 

    - Storage & Distribution

    - Laboratory Controls 

    - Validation

    - Rejection & Re-use of Materials 

    Q4. What is generic API manufacturing?

    The FDA describes a generic drug as a medication that has exactly the same active pharmaceutical ingredient as the brand name drug and yields the same therapeutic effect. It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used. However, generic pharmaceutical drugs do not need to contain the same inactive ingredients as the brand name product. 

    Generic drugs can only be manufactured once the patent protecting a brand name product expires, which could take upto 20 years. Following that, cost is the main difference between generic and brand name prescription drugs. Unlike branded companies, generic drug manufacturers engage in competitive pricing, resulting in lower prices for consumers.

    There is a general misconception that brand name drugs are superior and more effective than their generic counterparts, however, this is just a myth. The only reason that generic drugs are less costly than branded pharmaceutical drugs is because the drug manufacturer doesn't need to conduct extensive and expensive clinical efficacy and safety tests, unlike its predecessor.

    Generic API manufacturing is essentially equivalent to conventional API manufacturing, the only difference being that generic API manufacturing produces active pharmaceutical ingredients intended for generic finished dosage forms (FDFs) and not branded finished pharmaceutical products. 

    Generic API manufacturing including commercial scale API manufacturing is undertaken by active pharmaceutical ingredient (API) manufacturers from preformulation studies to commercial manufacturing, bypassing the clinical testing phase of API synthesis. Generic API manufacturing companies often commence these production services prior to the expiration of patents, by using high quality, non-patent infringing processes of API development and manufacturing.

    Q5. What are the key surprises and challenges involved in API manufacturing? How can they be handled by contract manufacturers?

    The pharma API market is expected to grow 5% annually reaching approximately $219 billion by 2023 and as the API manufacturing industry evolves it will tackle various challenges. Some of these challenges and their corresponding solutions are explored below: 

    Bad Raw Materials:

    - Using contaminated raw materials or raw materials that fail to meet the requirements outlined in the Drug Master Files, produce subpar APIs. These are often discarded or returned and can result in delays in time to market. 

    - CMOs or active pharmaceutical ingredient (API) manufacturers involved in API production can curb this activity by using trained and qualified personnel to source pharma APIs, perform site checks, and maintain relations with trusted raw material suppliers. 

     Low Yield:

    - There are various impurities that may arise at different stages of API manufacturing. Purification by sedimentation, filtration, centrifugation, etc. may be performed to remove these impurities, however, if it is highly contaminated then purification will yield low quantities of API. 

    - Using chemists with scientific expertise in handling such situations can reduce yield loss. Moreover, identifying impurity forming steps during API manufacturing and rectifying them can solve purification related low yield problems. 

    Scale up/Tech Transfer Problems:

    - Scale up and technology transfer are associated with risks that need to be managed in order for a mg procedure to become a multi-kg process. Sometimes new impurities and issues that dont arise during early phase small scale development can come up during late stage bulk drug substance manufacturing, which can be very costly.

    - Proper training of personnel, using advanced technologies, and spending more time assessing production and related issues during early stage small scale development can eliminate such problems plaguing API production.

    Regulatory Problems:

    - Not meeting regulatory requirements results in short timelines given by the regulatory agencies to rectify said issues, which can be difficult to cope with. 

    - Following the manufacturing guidelines in its entirety during the manufacturing process and ensuring compliance throughout the development process can result in speedier and less complicated regulatory approvals.

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    Evonik

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    Evonik is one of the world’s largest contract manufacturing organizations with a western-centered manufacturing network that can be relied upon to supply APIs, HPAPIs and intermediates up to the largest commercial volumes.

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    Fermion offers contract manufacturing services for drug substances with an API product portfolio consisting of over 30 generic APIs and over 10 NCEs. It also has the capability to produce highly potent compounds (HPAPIs).

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    Polpharma API supports large pharmaceutical customers in the manufacturing and development of their small-molecule APIs. It has more than 70 years of experience in cGMP manufacturing, process development & scale-up of active pharmaceutical ingredients.

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    Minakem provides fully integrated and technology-oriented contract manufacturing services ranging from process development, kilo lab and pilot scale-up to full industrial scale manufacturing of complex molecules including highly potent APIs (HPAPIs).

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    All custom synthesis and contract manufacturing projects of Interquim are governed by a flexible and effective management system with the aim of optimising the time to market, while maintaining the highest quality standards & minimising development costs.

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    Lebsa is a strategic partner that offers API contract manufacturing services from a few grams to some kilograms in its GMP pilot plant. It also offers analytical services and regulatory support for active ingredients.

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    Malladi Drugs & Pharmaceuticals Limited

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    Malladi is a leader in manufacturing Ephedrine & Pseudoephedrine salts. It provides contract manufacturing services for a range of APIs & intermediates. Its GMP compliant manufacturing facilities are state-of-the-art facilities approved by the USFDA.

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    Century Pharmaceuticals offers contract manufacturing services for active pharmaceutical ingredients (APIs) and intermediates as per your requirements.

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    CBL offers contract GMP peptide synthesis from laboratory scale to commercial production. It provides peptide starting materials, peptide intermediates and commercial-scale manufacturing of GMP and non-GMP peptides.

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    Axplora

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    Axplora is a leading CDMO offering process development, scale-up, clinical and commercial manufacturing services. It provides contract manufacturing for complex APIs, advanced intermediates, and biomolecules.

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    Kimia Biosciences

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      As a contract manufacturing organization (CMO), Kimia Biosciences makes high-quality APIs and intermediates that serve the highly regulated markets of the USA, Europe, and Japan etc.

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      Acharya Chemicals

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      Acharya Chemicals offers contract research and custom manufacturing for APIs, intermediates and specialty chemicals. It comprises five independent manufacturing facilities capable of handling production from laboratory to plant scale.

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      Avra Labs is a contract manufacturer for APIs covering oncology & other therapeutic areas. Its state-of-art manufacturing facilities spread over 30 acres with a total reactor volume over 165,000 lit are located in Hyderabad (US FDA approved) & Vizag.

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      Avra Labs Contract Manufacturing for APIs

      CPhI Japan

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      Polfa Tarchomin

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      Polfa Tarchomin as a few of the European companies still possesses facilities dedicated to synthesis and contract manufacturing of APIs. Various antibiotics as well as cytostatic products can be synthesised, isolated, purified and micronised.

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      Polfa Tarchomin CMO of APIs & Micronisation

      CPhI Japan

      Not Confirmed

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      Norchim

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      CRO OF ACTIVE PHARMACEUTICAL INGREDIENTS

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      Norchim was originally an API manufacturer and a contract organization to provide intermediates to the pharmaceutical industry.

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      Norchim CB

      CPhI Japan

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      USV Private Limited

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      Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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      PEPTIDE API CONTRACT MANUFACTURING

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      USV is engaged in the custom synthesis and contract manufacturing of peptide active pharmaceutical ingredients (APIs). Its US-FDA-approved GMP manufacturing facilities offer the synthesis and production of high-quality custom peptides.

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      Peptide API Contract Manufacturing

      CPhI Worldwide, Milan

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      Suanfarma CDMO

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        API CONTRACT MANUFACTURING SERVICES

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        Suanfarma CDMO has the best know-how and state-of-the-art technologies to carry out fermentation, purification, and chemical synthesis processes in their CDMO plants including Regulatory support.

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        Suanfarma API Contract Manufacturing Services

        CPhI China

        Booth #E1N28

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        Medichem S.A

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        Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
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        API CONTRACT MANUFACTURING

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        Medichem offers a wide range of contract manufacturing services for active pharmaceutical ingredients (APIs) and HPAPIs.

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        API Contract Manufacturing

        CPhI North America

        Booth #644

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        Egis Pharmaceuticals PLC

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        API CONTRACT MANUFACTURING

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        Egis Pharmaceuticals involves contract manufacturing of active pharmaceutical ingredients & intermediates using organic chemical synthesis on large-scale production lines. It can produce a wide range of APIs including highly potent APIs & small molecules.

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        API Contract Manufacturing

        CPhI Japan

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        Gensenta Pharmaceuticals

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        API CONTRACT MANUFACTURING

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        Gensenta's penicillin API production facility & additional 3 facilities, including oncolytic, non-penicillin, and small-scale API productions, equipped with technology & operated by skilled professionals, are a commitment to excellence in API production.

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        Pharma Service: API Manufacturing

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        API Contract Manufacturing

        CPhI Worldwide, Milan

        Booth #16C17

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        Navin Fluorine International Limited

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          MANUFACTURING SERVICES (CRAMS)

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          NFIL is in the business of offering Contract Research and Manufacturing Services (CRAMS) for custom chemical syntheses of fluorinated compounds for the pharmaceuticals, agro chemicals and speciality chemicals industries.

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          Avara Pharmaceutical Services

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            cGMP CONTRACT MANUFACTURING OF API

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            Two of Avara’s sites provide active pharmaceutical ingredient (API) development & manufacturing. All CDMO facilities worldwide have a long-term record of quality and cGMP regulatory compliance.

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            Orofino Pharmaceuticals Group

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            MANUFACTURING OF API & FINISHED PRODUCTS

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            In addition to contract manufacturing, Orofino Pharmaceuticals Group can offer a range of qualified services particularly in the quality, technical and regulatory areas.

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            Recipharm AB

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            API CONTRACT MANUFACTURING

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            Recipharm has more than 20 years experience in drug substance development & manufacturing. Recipharm's multi-purpose plant can manufacture several API products at a time, including generic and hormonal APIs.

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            Shanghai Chemspec Corporation

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            HIGHLY ENGINEERED FLUORINATED OR OTHER SPECIALTY CHEMIC...

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            Chemspec has built up one R&D center (12,000M2) and 4 production sites in mainland China, which enable them to provide integrated services from R&D to commercial production with timely delivery of high-quality products at competitive price.

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            Dr Pradeep Reddy’s Laboratories Private Limited

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              CUSTOM SYNTHESIS & MANUFACTURING OF APIs

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              Dr Pradeep Reddy’s Laboratories offer custom contract manufacturing of APIs or intermediates by working with our partner pharmaceutical companies in India and across the globe.

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              Flamma SpA

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              CUSTOM MANUFACTURING OF APIs

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              Our ability to move quickly from the R&D laboratory to multi-kilo amounts into the pilot plant or into full production is a strength at Flamma. We have the flexibility to look at our sites to determine the best place to manufacture your materials.

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              Priyans Drugs

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                CONTRACT MANUFACTURING

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

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                BioSpectra

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                CONTRACT MANUFACTURING

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                BioSpectra is a FDA registered, cGMP compliant, contract manufacturer and commercial producer of biological buffers, pharmaceutical excipients and laboratory reagents.

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                CRMO Pharmmatecch

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                  CONTRACT MANUFACTURING OUTSOURCING

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                  CRMO has successfully catered to diverse pharmaceutical outsourcing requirements of number of European, US and Japanese customers because of the in depth knowledge of the Indian pharmaceutical industry and sound understanding of outsourcing trends.

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                  CLEARSYNTH LABS LIMITED

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                    CONTRACT R&D SYNTHESIS

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                    CLEARSYNTH efforts focus from the pre-clinical stage through to phase III and to the successful technology transfer to manufacturing locations throughout the world.

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                    Orchid Pharma

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                    GMP COMPLIANT API MANUFACTURING

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                    Our API manufacturing plant specialises in the manufacture of cephalosporin APIs. Our contract manufacturing complex has been successfully audited by leading global regulatory agencies like the US FDA, UK MHRA, GMP, EDQM, TGA , Danish Medicines Agency.

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                    Pharma Service: API Manufacturing

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                    Ocimum Labs

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                      API CONTRACT MANUFACTURING SERVICES

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                      Ocimum Labs offers contract manufacturing services for active pharmaceutical ingredients (APIs), key starting materials and drug intermediates, along with tech transfer and scale-up management.

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                      Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                        CONTRACT MANUFACTURING CAPABILITIES

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                        - Service Details

                        Dorrapharma is engaged in R&D, manufacture and market of intermediate, API (Active Pharmaceutical Ingredients) and formulation. We stick to raise the value both for the company and customer, and strive for serving for the society and caring of the others.

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                        ScinoPharm Taiwan, Ltd

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                        CONTRACT API MANUFACTURING

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                        ScinoPharm offers a wide array of process R&D services & API manufacturing capabilities designed to satisfy their customers' exact requirements & facilitate rapid market introductions. ScinoPharm specializes in process R&D & cGMP API manufacturing.

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                        Fujian South Pharmaceutical

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                          API CONTRACT MANUFACTURING

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                          - Service Details

                          State-of-the-art facility will be installed and GMP compliance will be in place to provide contracted manufacture service to international market.

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                          Unique Biotech Limited

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                          CONTRACT MANUFACTURING

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                          UBL's state-of-the-art manufacturing facility provide the best platform to custom make your formulas into quality products.

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                          ChemCon GmbH

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                          API CONTRACT MANUFACTURING

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                          ChemCon offers API contract manufacturing services for quantities ranging from 100 gm to a few hundred kilograms per annum. It provides API production for both clinical studies and commercial applications.

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                          Robinson Brothers

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                            CONTRACT AND TOLL MANUFACTURING

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                            Our site can seamlessly and rapidly scale processes and products as necessary from laboratory grams to kilograms in Kilo-Laboratory and/or Pilot Plant facilities, and thence in a Production Operations Plant to multi-tonne quantities.

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                            Ash Stevens, Inc.

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                            API MANUFACTURING

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                            Ash Stevens has a longstanding track record & reputation as a preferred supplier of innovator APIs. We are a fully integrated pharmaceutical contract manufacturer supporting all aspects of drug substance development & manufacturing, from early-stage development to commercial API production.

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                            Kekule Pharma

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                            API CONTRACT MANUFACTURING SERVICES

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                            Kekule Pharma offers various services including API contract manufacturing, impurity synthesis, process development, scale up studies, etc. It has dedicated manufacturing facilities for oncology APIs and clean room facilities for synthetic APIs.

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                            SPC Lifesciences Pvt. Ltd

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                              CONTRACT MANUFACTURING OF APIs

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                              We are strong partners to some of the best generic pharma companies in India and around the world for their increasing need for stringent quality, regulatory compliant and complex chemistry handling facilities.

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                              Menadiona

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                              API CONTRACT MANUFACTURING SERVICES

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                              Menadiona's fine chemical division offers custom & contract manufacturing services. They are specialized in manufacturing APIs & key intermediates for the pharmaceutical, veterinary, plant health and nutraceutical industries.

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                              Cerbios-Pharma SA

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                              API CONTRACT MANUFACTURING

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                              Cerbios offers contract manufacturing for APIs, HPAPIs, ADCs and biologics. It has over 40 years of experience in generic APIs (for the worldwide market).

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                              ZCL Chemicals Limited

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                              CMO FOR APIs & ADVANCED INTERMEDIATES

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                              With the best in class drug manufacturing facilities & state-of-the-art research platforms, we have embarked on establishing a contract manufacturing organization (CMO) for APIs, advanced intermediates & intermediate for controlled substances.

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                              Crenza Pharma

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                                CMO IDENTIFICATION

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                                Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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                                Biological E

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                                ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)

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                                "We have dedicated manufacturing facilities for Solid Dosage Forms, Liquid Orals and Syrups, Parenterals and Active Pharmaceutical Ingredients and continue to invest in world-class facilities that will be in accordance with US FDA and EMEA standards."

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                                Solara Active Pharma Sciences

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                                GMP CONTRACT MANUFACTURING SERVICES

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                                Solara provides customer-oriented contract research and manufacturing services (CRAMS), synthetic development services, analytical development services, GMP manufacturing, kilo-lab services, etc.

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                                Dishman Carbogen Amcis

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                                API/HPAPI/INTERMEDIATE CONTRACT MANUFACTURER

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                                The Dishman CRAMS business offers an unparalleled range of facilities dedicated to contract manufacture of APIs, Highly Potent APIs (HPAPIs) and advanced intermediates & speciality chemicals for pharmaceutical customers.

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                                CLEARSYNTH LABS LIMITED

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                                  SMALL MOLECULE MANUFACTURING

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                                  Chemically manufactured small molecules are the classic active drug substance that continues to be the "engine of growth" in the pharmaceutical industry

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                                  ZCL Chemicals Limited

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                                  cGMP COMPLIANT CONTRACT MANUFACTURING

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                                  To aid the green-field API facility expansion, ZCL has set up a modern pilot plant facility to manufacture multi-kilogram of API and intermediates under cGMP conditions.

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                                  Piramal Pharma Solutions

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                                  API CONTRACT MANUFACTURING

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                                  With a successful performance record of over 40 years, Piramal manufactures & supplies active pharmaceutical ingredients (APIs) through its sites in North America, Europe & Asia. Its facilities are approved by the US FDA, Japan PMDA & UK MHRA.

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                                  Curia

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                                  API CONTRACT MANUFACTURING

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                                  Curia offers contract API manufacturing services for a large portfolio of steroids and hormones with fully integrated discovery and development solutions.

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                                  SIMS Srl

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                                  CUSTOM TOLL MANUFACTURING

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                                  SIMS has acquired a growing recognition in the field of custom-toll manufacturing by collaborating with the main pharmaceutical companies; advanced technologies are available to customers to satisfy all specific and exclusive requests.

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                                  Aragen Life Sciences

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                                  API CONTRACT MANUFACTURING

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                                  GVK BIO offers long term Contract Manufacturing services right from strategic partnerships in development, validations, DMF filing and commercial manufacturing of Active Pharmaceutical Ingredients (APIs)/advanced intermediates to APIs.

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                                  Concord Biotech

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                                  CONTRACT RESEARCH & MANUFACTURING

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                                  Concord is providing services from conceptualization to commercialization to global companies as part of its Contract Research & Manufacturing business in the area of fermentation and semi-synthesis products.

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                                  Grunenthal

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                                  CONTRACT MANUFACTURING

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                                  Our plants in 5 locations operate as full-service CMOs vertically integrated from API to finished products with a strong service portfolio including controlled drugs handling, regulatory services, production process design export into 100 countries.

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                                  Olon S.p.A

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                                  CONTRACT 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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                                  Diverchim S.A.

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                                  A COMBINED CRO & CMO

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                                  DIVERCHIM is a combined Contract Research Organisation (CRO) and Custom Manufacturing Organization (CMO) in Organic Chemistry dedicated to the development and the production of small quantities molecules from tens of milligrammes to tens of kilogrammes per batch.

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                                  Onyx Scientific

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                                    NON-GMP MANUFACTURING

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                                    Onyx Scientific's custom-built non-GMP manufacturing laboratories feature 50 L vessels & 100 L work-up vessels, as well as multi-kilo chromatography capabilities. It manufactures 3-5 kg batches with suitability for GLP toxicity studies (CoA, TSE).

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                                    Biovian

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                                      CDMO FOR MICROBIAL PRODUCTS

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                                      Biovian is a one-stop-shop CDMO for GMP manufacture and development of biopharmaceuticals. Biovian offers cell line development, mammalian cultivation, microbial fermentation, protein purification, viral vector production, formulation, aseptic filling, labeling and QP release.

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                                      Jubilant HollisterStier

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                                      SOLID & SEMI SOLID CONTRACT MANUFACTURING

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                                      Jubilant Pharma is a subsidiary of Jubilant Life Sciences, an integrated global pharmaceutical and life sciences company, which has been ranked No. 6 amongst the Top 10 global contract manufacturing & services outsourcing players of the pharmaceutical industry.

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                                      DrugOn Pharma Switzerland

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                                        INTERMEDIATE & API CONTRACT MANUFACTURING

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                                        Drugon was the last company to be set up in the Orofino Group, which bought out the ex Knoll and Abbott manufacturing site in Liestal, Switzerland. The contract manufacturing site produces active pharmaceuticals ingredients (API) and intermediates.

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                                        Quality Chemicals

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                                        CUSTOM TOLL MANUFACTURING

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                                        Quality Chemicals offers toll manufacturing of custom products using raw materials provided by the customer. They also provide custom purification & synthesis, custom solution & reagents, custom particle size and quality control.

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                                        Sekisui Diagnostics (UK) Limited

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                                          CONTRACT MANUFACTURING

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                                          Our facilities and expertise include world-class fermentation based manufacturing, along with fully integrated Research and Development, Quality and Engineering.

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                                          Biovian

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                                            CDMO FOR MAMMALIAN PRODUCTS

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                                            Biovian provides mammalian cell based production of API´s and Drug Substances. Biovian has separate mammalian GMP-manufacturing unit comprising state-of-the art bioreactor, harvesting equipment and several downstream suites and equipment which allows flexible production scenarios.

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                                            Biovian

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                                              CDMO FOR VIRAL VECTOR PRODUCTS

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                                              Biovian has extensive experience and knowledge in Viral Vector Production for gene therapy applications. Biovian holds EMA license for producing Viral vector products for clinical trials as well as for commercial use.

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                                              Aesica Pharmaceuticals Limited

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                                              API CONTRACT MANUFACTURING

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                                              With over 30 years’ experience in the supply of bulk APIs, we can supply generic products on a contract manufacturing basis.

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                                              Huvepharma Italia S.r.l

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                                                CONTRACT 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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                                                Onyx Scientific

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                                                  COMMERCIAL API MANUFACTURING

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                                                  Onyx Scientific's commercial API manufacturing services are available from both its US & UK sites, to support your small molecule API throughout the entire product lifecycle.

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                                                  Almelo

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                                                    ACTIVE PHARMACEUTICAL INGREDIENTS

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                                                    Our API facility located inMedak, Telangana (India) is spread across a vast area of 65 acres, with a provision for nine production blocks of which one block is currently up and running with state-of-the-art technology for material charging and material movement.

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                                                    Cambrex Corporation

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                                                    DRUG SUBSTANCE CONTRACT 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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                                                    DPT Laboratories, Ltd

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                                                    CONTRACT API MANUFACTURING

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                                                    DPT identifies the best solutions for pharmaceutical manufacturing, providing services for everything from pilot batches, to clinical trial materials, to full-scale commercial cGMP production.

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