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    Overview of sterile manufacturing contract services for parenteral preparations, sterile injectables & lyophilized products offered by CDMOs & CMOs.

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    Overview of sterile manufacturing contract services for parenteral preparations, sterile injectables & lyophilized products offered by CDMOs & CMOs.

    Q1. What are parenteral preparations?

    Parenteral preparations are sterile preparations containing one or more active ingredients intended for administration by injection, infusion or implantation into the body. They are packaged in either single-dose or multidose containers. 

    Parenteral preparations may also be defined as solutions, suspensions, emulsions for injection or infusion, sterile powders for injection or infusion, and gels for injection and implantation that enter systemic circulation and typically provide rapid onset of action in comparison to orally administered drug products. 

    There are various CDMOs and CMOs offering contract manufacturing for parenteral formulations.  Furthermore, parenterals are drug products that reach the body by circumventing the gastrointestinal tract, including liquid drug products. 

     

    Parenteral Drug Delivery - Routes of Administration:

    * Intravenous

    * Intramuscular

    * Subcutaneous

    * Intradermal

    * Epidural

    * Intra-articular

    * Intrathecal

     

    Types of parenteral preparations based on physical attributes:

    - Solutions or emulsions: Medicaments suitable for injection.

    - Sterile solids: Drugs which are not stable as solutions (dry sterile solids dissolved in suitable solvents). 

    - Sterile suspensions: Suitable solvents administered via the intramuscular route of administration. 

    - Transfusion fluids: Solutions administered via the intravenous route of drug delivery.

     

    Types of Parenteral Preparations based on Volume:

    - Small Volume Parenterals

    Sterile pyrogen free preparations intended to be delivered via a parenteral drug delivery route, supplied in single or multiple doses. Its volume is generally less than or equal to 100 ml and often ranges from 1-30 ml. Small-volume parenteral products are often presented in vials or ready-to-use pre-filled syringes, providing ease-of-use in the clinical setting or for patient self-administration. 

    - Large Volume Parenterals

    Sterile preparations containing active ingredients mostly supplied in a single dose of more than 100 ml. Large volume parenterals are delivered through the intravenous route of administration. They generally provide electrolytes and nutrition to the body.

     

    Advantages of parenteral preparations as compared to other dosage forms:

    - Faster onset of action

    - Drugs that can’t be delivered orally may be delivered by the parenteral route of administration

    - Improve adherence 

    - Enable administration to patients who are unconscious or otherwise unable to receive medication

    - Control over drug delivery 

    - Parenteral administration can result in local effect for drugs when desired

    - Parenteral therapeutics provide a means of correcting serious disturbances of fluid and electronic balances

    - The drug action can be prolonged by modifying the formulation.

    - Easy to formulate

    - Uniform doses 

    Q2. What are the considerations involved in developing complex parenteral formulations?

    Complex parenteral formulation or drug product challenges classically pertain to the attainment of a target physicochemical characteristic, eg, active concentration/drug loading or particle size distribution.

    Like simple formulations, complex formulations must be formulated to be safe, stable, and effective in the target patient population. They must align with regulatory expectations and be manufactured under strict aseptic control. Yet compliance with rigid guidelines is a challenge that continues to elude companies offering sterile contract manufacturing for parenteral formulations worldwide. 

    Developing different complex parenteral formulations depends on a number of factors including desired route of administration, area of administration, onset of action, rate of drug release, shelf life, etc. Some additional general considerations which are paramount for developing parenteral dosage forms, are noted below.

     

    - Stability: All products must be stable, not only chemically and physically like all other dosage forms, but also ‘stable’ microbiologically. This further helps parenteral preparations to have longer shelf lives and assures safety and potency to consumers. 

    - Sterility: All parenteral products must be sterile. This is of paramount importance as these products are administered directly into the bloodstream, bypassing the body’s natural defenses. Contamination of parenteral drug products, therefore, can have serious consequences on the patient.

    - Apyrogenicity (Chemical purity): All parenteral preparations must be free from endotoxin contamination. The most important type of pyrogen in pharmaceutical fields is bacterial endotoxin, which, if present in a parenteral pharmaceutical, can result in a pyrogenic response (chills, fever, headache, myalgia, malaise) by the consumer.

    - Isotonicity: Products should be isotonic, although strictness of tonicity depends on the route of administration. It is important because isotonicity reduces the chances of hemolysis, the possibility that the parenteral preparation may penetrate red blood cells. 

    - Excipient Selection: Selecting suitable excipients during the preliminary stages of drug product development and manufacturing  is crucial. It is also important in case of parenteral development. Parenteral preparations need careful planning and thorough knowledge of medicaments and adjuvants to be used. The excess use of adjuvants in parenteral products should be avoided as some of these may interfere with the drug.

    - Commercial Production: Parenteral development chemistries must serve commercial and sterile manufacturing interests as formulation has direct influence on scale-up and process variability, stability and other processing, and manufacturing-oriented aspects related to successful commercial drug product development and manufacturing.

     

    There are copious other considerations taken into account prior to commencing parenteral contract manufacturing or contract manufacturing of injectables. This enables the production of superior products that elicit the desired therapeutic effects upon administration in a convenient and timely manner. Services for contract manufacturing of injectables and contract manufacturing for parenteral formulations are offered by various CDMOs and CMOs.

    Q3. What are the steps involved in manufacturing sterile injectables?

    Injections are sterile solutions or suspensions of drug products in an aqueous or oily vehicle meant for introduction into the body by means of an injectable needle, under or through one or more layers of the skin or mucous membrane.  

    Only liquid dosage forms can be injected which means that parenteral preparations must either be a liquid which can itself be injected safely, or it may be a material that can be diluted with sterile water or other sterile solvents before it is administered.

    Parenteral preparations may require the use of excipients such as solvents, substances to enhance solubility, suspending agents,buffering agents, substances to make the preparation isotonic with blood, stabilizers or antimicrobial preservatives. In general, there are two ways of manufacturing sterile injectables or sterile drug products; (1) Terminal Sterilization and (2) Aseptic Sterile Manufacturing.

     

    Contract Manufacturing of Injectables - Methods:

    (I) Terminal Sterilization

    Terminal sterilization is the process of sterilizing a product in its final container. It is an important process as it ensures the product remains sterile. All medical, ophthalmic and parenteral equipment are sterilized in batches, and are usually sterilized using heat.

    (II) Aseptic Sterile Manufacturing and Sterile Fill-Finish

    Aseptic filling of sterile drugs, also known as sterile fill finish, remains one of the most critical processes in pharmaceutical sterile manufacturing. This is due to its highly technique driven processes and the potential safety impact to the end user, usually an already compromised patient. 

     

    General steps involved in manufacturing sterile injectable dosage forms:

    I. Pre-formulation & Formulation Studies 

    The first step of manufacturing sterile injectables is performing extensive pre formulation studies for identifying physical attributes (pH stability, thermal stability, etc.) of potential drug formulations and formulation studies to identify requirements of certain excipients (surfactant, stabilizer, etc.). Subsequently, a suitable drug candidate and compatible excipients are chosen to constitute the final drug formulation. 

    II. Process Compatibility

    The next step includes learning how the formulation behaves/interacts in an aseptic manufacturing facility when it comes into contact with different materials, enumerated below. Process optimization is achieved after analyzing the results of such studies. 

    1. Glass

    2. Stainless steel

    3. Process tubing

    4. Plastics

    - Other Materials

    III. Compounding/Mixing

    The chosen raw materials then undergo the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding involves combining two or more drugs.

    IV. Filtration

    Filtration through a membrane and/or filtering processes using compressed gas and air are used in parenteral contract manufacturing or sterile injectable contract manufacturing, to remove unwanted materials from the formulated bulk solution. 

    V. Filling

    Once the product has been filtered into a sterile filling container and the filter passes the postfill integrity test, it is now ready to fill into its primary container. The product is generally filled into glass vials; however, different types of containers can be used for filling depending on the product.

    VI. Terminal Sterilization

    Parenteral products must undergo some form of sterilization, and terminal sterilization is generally the preferred method. Terminal sterilization is the preferred method for drug products because, in this process, sterilization takes place after the product has been filled into the primary packaging. Because of this, there are no further opportunities for contamination due to human intervention. 

    VII. Lyophilization

    Contract manufacturing of lyophilized injections is achieved via lyophilization. Lyophilization is the removal of water from frozen state to the gaseous state without going into the liquid state. In lyophilization of parenterals, the drug is dissolved in an appropriate solvent and converted to ice form at a very low temperature between ?50 °C and ?90 °C.

    VIII. Closing/Stopping

    Pre-sterilized stoppers and caps are then used to seal the containers filled with the sterilized and lyophilized drug formulations or lyophilized products. 

    IX. Inspection 

    After the product is released following QA & QC testing, inspections of the physical attributes of the drug products and containers are performed prior to labeling.

    X. Labeling 

    Sophisticated label solutions can play an important role in supporting product and patient safety. Labels serve to clearly and reliably mark the pharmaceutical product by providing information on the product, its administration, batch number, expiry date, etc.

    XI. Packaging 

    Secondary packaging is then carried out to prepare the parenteral formulations for large-scale distribution and commercialization.

    Q4. How are lyophilized injections a boon to injectable dosage forms?

    Lyophilization is a water removal process through which perishable items are preserved. Lyophilization is the process of preserving something by freezing it very quickly and then subjecting it to a vacuum which removes ice.

    Lyophilization is one of the most effective methods for the long-term preservation of cells. Freeze drying, known as lyophilization, may be used to prepare a dosage form that is to be reconstituted for injections. This process boosts the shelf life of the material and also makes it easier to transport by injectable and parenteral CDMOs or CMOs offering contract manufacturing services for sterile injectables. 

     

    Lyophilization: Three stages 

    I. Freezing

    The first and most critical stage of lyophilization is the freezing phase. There are various methods to freeze the product. Freezing can be done in a freezer, a chilled bath (shell freezer) or on a shelf in the freeze dryer. Cooling the material below its triple point ensures that sublimation, rather than melting, will occur. 

    II. Primary drying

    Primary drying, the sublimation stage, is the process of converting ice directly into a gas without melting. The product is held at a temperature lower than the eutectoid of the ice and controlled vacuum conditions are used to remove the vapour.

    III. Secondary drying

    Secondary drying (adsorption) removes the bound water molecules. The temperature is slowly raised to higher than that in the primary drying phase. Bonds are broken between the material and the bound water molecules. The temperature for this process is usually between 10°C and 50°C and usually requires a long duration.

     

    Lyophilized injections are the best alternative to oral solid dosage forms. After contract manufacturing for lyophilized injections is performed, they are packed in lyophilized vials. Lyophilized injections provide better patient compliance, especially in bed ridden patients.  

    Now-a-days,there are many CDMOs offering contract manufacturing for lyophilized injections. Lyophilized injection dosage forms are extensively used to improve the bioavailability, stability, solubility of injectable formulations. Lyophilized injections are prescribed to attain maximum bioavailability and stability in patients suffering from a number of diseases. 

     

    Other advantages of lyophilization and lyophilized products include:

    - Ease of processing a liquid, which simplifies aseptic handling

    - Enhanced stability of a dry sterile powder

    - Removal of water without excessive heating of the product

    - Enhanced product stability in a dry state

    - Rapid and easy dissolution of reconstituted product

    - Increased shelf life 

    - Reduce weight and volume for better transportation

    - Avoids sample shrinking

    Q5. Who are the leading contract manufacturers for injectable formulations?

    Some of the leading injectable and parenteral CDMOs and CMOs offering sterile contract manufacturing services for parenteral or injectable dosage forms include:

     

    Madras Pharmaceuticals

    Steril-Gene Life Sciences, a joint venture between the Madras Pharma Group and Lloyd Laboratories, a pharmaceutical CMO, offers sterile injectable contract manufacturing services for a range of pharmaceutical preparations like tablets, softgel capsules, general injections, lyophilized injections (lyophilized products), etc. They also have injection block facilities for liquid injections in ampoules, vials and lyophilized vials. 

     

    Bioindustria L.I.M. Spa

    Bioindustria Laboratorio Italiano Medicinali L.I.M. S.p.A. has a long tradition in the pharmaceutical business and specializes in large and small volume injectables with terminal sterilization or with aseptic process, lyophilised dosage forms in lyophilized vials , tablets and capsules.  They provide contract manufacturing for lyophilized injections and also offer sterile injectable contract manufacturing (parenteral contract manufacturing services).

     

    Quotient Sciences

    Quotient Sciences provides enhanced d formulation decision-making in early phase clinical trials for parenteral products. They follow a GMP compliant approach and offer contract manufacturing for parenteral formulations for rapid clinical assessment. 

    They provide parenteral quality control services and programs to optimize parenteral formulations. Furthermore, Quotient Sciences also offers high-potency API contract manufacturing of injectables. 

     

    Recipharm AB

    Recipharm, a pharmaceutical injectable and parenteral CDMO, develops injectable dosage forms for clinical trials as well as for market launch. They have the competence to work with all types of parenteral products such as those delivered via the intravenous, intramuscular and subcutaneous routes of administration. 

    Their drug product development and manufacturing (parenteral development) team has experience with essentially all types of parenteral formulations and provide solutions, dispersed systems and sterile powder formulations. They have dedicated facilities to manufacture smaller batches of clinical trial material and commercial manufacturing sites for larger clinical batches.

     

    Biopharma

    Biopharma, an FDA approved CMO for beta lactam antibiotics finished drug products, has a wide and global experience in contract manufacturing for parenteral formulations. Apart from contract manufacturing of injectables, they also produce various oral dosage forms.

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    AbbVie Contract Manufacturing

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    ASEPTIC FILL & FINISH SERVICES

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    AbbVie offers two convenient fill and finish options for parenteral drug products, including prefilled syringes and vials. It can provide all the necessary elements for delivering high-quality parenteral products to meet clinical and commercial needs.

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    STERILE DOSAGE FORM MANUFACTURING

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    Famar has extensive experience with all major sterile dosage form types and offers state-of-the-art freeze-drying processing. It provides worldwide customized solutions for injectable ampoules and vials meeting the high-quality standards.

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    CMO OF PARENTERAL DOSAGE FORMS

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    Polfa offers contract manufacturing especially for injectables. In general it can produce sterile powders in vials, liquids in ampoules; & insulin cartridges. Its drugs are manufactured in buildings that meet strict requirements and quality standards.

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    Polfa Tarchomin CMO of Parenteral Dosage Forms

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    COMPLEX PARENTERAL DRUG PRODUCT MANUFACTURING

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    Evonik is one of the world’s leading manufacturing organizations in the pharmaceutical industry for complex parenteral drug products. It has a fully integrated portfolio of services for aseptic filling of parenteral formulations.

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    INJECTABLE MANUFACTURING

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    Temad has active production lines and more than 70 kinds of pharmaceutical products including injections, pellets, and other medicines that are controlled and evaluated according to GMP standards and WHO terms.

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    Temad Injectable Manufacturing

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    PENICILLIN GROUP INJECTABLE

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    ASTRAL is associated with leading national and multinational pharma companies like Pfizer, Ranbaxy, Zydus Cadila, Cipla, Orchid, Alembic, Sun Pharma, Blue Cross, Intas, Unique and Dr. Reddy's, as the contract manufacturer for their products for domestic and export segments.

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    STERILE DRUG PRODUCT MANUFACTURING

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    Fareva is involved in the contract manufacturing and development of highly potent and freeze-dried injectables and pre-filled syringes. It also assists in the production of sterile gels and ointments.

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    Sharp has partnered with Berkshire Sterile Manufacturing (BSM), a fill and finish contract manufacturer incorporating 100% isolator-based sterile filling for syringes, vials and cartridges for the biotech and pharmaceutical industries.

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    TriRx has over 40 years of experience in producing high-quality sterile formulations. Its offers contract manufacturing for a range of sterile drug products such as solutions, ointments, and suspensions.

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    Aurigene Pharmaceutical Services is a leading CRO/CDMO that provides end-to-end solutions. Its formulation manufacturing capabilities based out of India & USA include liquid & lyophilized injections, prefilled syringes & powder for reconstitution.

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    Biopharma Group

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      Biopharma Group provides freeze drying for up to 3200 2R vials from its state-of-the-art ATS Hull S10 freeze dryer. It helps in the preparation of dried or liquid products into vials or well plates along with their packing, kitting, and shipping.

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      Ethypharm

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      Ethypharm has a longstanding expertise in the development and manufacturing of injectable formulations. Its sterile drug products include ampoules, pre-filled syringes, flexible IV bags, injectable solutions, and suspensions.

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      Gensenta Pharmaceuticals

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      Gensenta offers fill and finish options for parenteral drug products, including liquid and lyophilized vials. It can provide all the necessary elements for delivering high-quality parenteral products to meet clinical and commercial needs.

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      Tianjin Hankang Pharmaceutical Biotechnology

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        CMO FOR INJECTABLES

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        Hankang's Hanrui Pharmaceutical is experienced in the contract manufacturing of complex injections, freeze-dried agents, and other dosage forms.

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        Pfizer CentreOne

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        CONTRACT MANUFACTURING OF STERILE INJECTABLES

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        Pfizer CentreOne, one of the world’s leading injectables manufacturers offers contract manufacturing for sterile injectables including scale-up from lab to pilot to commercial, clinical manufacturing phase I - III, etc.

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        Contract Manufacturing of Sterile Injectables

        CPhI North America

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        Evonik

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        CMO FOR COMPLEX PARENTERAL DRUG PRODUCTS

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        Evonik is one of the world’s leading manufacturing organizations in the pharmaceutical industry for complex parenteral drug products. It offers cGMP clinical and commercial manufacturing for a range of parenteral drug products.

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        Pharma Service: Drug Product Manufacturing

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        CMO for Complex Parenteral Drug Products

        CPhI North America

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        Astral SteriTech

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        CEPHALOSPHORIN GROUP INJECTABLE

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        ASTRAL is associated with leading national and multinational pharma companies like Pfizer, Ranbaxy, Zydus Cadila, Cipla, Orchid, Alembic, Sun Pharma, Blue Cross, Intas, Unique and Dr. Reddy's, as the contract manufacturer for their products for domestic and export segments.

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        Centrient Company Banner

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        Curida AS

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          MANUFACTURING OF STERILE LIQUID

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          Curida’s core competency is in state-of-the-art manufacturing of sterile liquid pharmaceuticals based on nunit-dose Blow-Fill-Seal (BFS) technology, ensuring a high quality, fast and robust process with minimal human intervention

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          BirgiMefar Group

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          INJECTABLE SOLUTIONS IN VIALS

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          Injectable solutions and suspensions are filled in vials of 2ml up to 300ml.

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          BioTechnique

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            STERILE INJECTABLE CONTRACT MANUFACTURING

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            From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and optional lyophilization services for a wide variety of liquid injectables.

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            Brooks laboratories Limited

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              LIQUID INJECTION DOSAGE FORMS

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              Brooks Laboratories a WHO GMP & ISO 9001:2008 certified company is in the business of pharmaceuticals and is in contract manufacturing, marketing and exports.

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              Mithra CDMO

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              COMMERCIAL MANUFACTURING FOR STERILE INJECTABLES

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              Our team combines expertise in drug development & formulation for generic applications or new chemical entities with an understanding of commercial contract manufacturing processes for long acting forms, sterile injectables and hormonal tablets.

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              Flagship Biotech International Pvt. Ltd

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              SPECIALITY INJECTABLES DOSAGE FORMS

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              Flagship biotech has capability to manufacture high quality solid & liquid dosage forms, LVP, SVP, speciality injectables, powder for injections, inhalers, ointments, creams, etc.

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              BirgiMefar Group

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              PARENTERAL SOLUTIONS & SUSPENSIONS

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              Parenteral solutions and suspensions are filled in ampoules of 0,5ml up to 30ml.

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              BioTechnique

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                CYTOTOXIC PRODUCTS

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                BioTechnique’s facility is designed to handle cytotoxic and highly potent products to both FDA and EU standards

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                Orofino Pharmaceuticals Group

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                FILLING OF ASEPTIC SOLUTIONS IN AMPOULES

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                Injectalia serves as CMO for small sterile liquids medicinal finished products including hormones, corticosteroids, biologicals, small chemicals entities in prefilled syringes and filling of aseptic solutions & diluents in ampoules.

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                HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD.

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                LMW HEPARIN CALCIUM/ SODIUM INJECTION

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                The workshops of Changshan Pharm for producing API, small volume injection, tablet and hard capsule owned GMP certificate and work in strict accordance with the requirements in GMP as to production and process flow. It also owns European CEP certificate and French GMP certificate.

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                Farbe Firma

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                GENERIC INJECTABLE FORMULATIONS

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                We have a well-equipped laboratory and are capable of handling wide variety of all generic injectable formulations.

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                Orofino Pharmaceuticals Group

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                ORAL & INJECTABLE DOSAGE FORM MANUFACTURING

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                BIOPHARMA, an FDA approved CMO for betalactam antibiotics finished drug products, with a wide and global experience in contract manufacturing, produces various oral and injectable dosage forms.

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                PENMIX LTD.

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                  PARENTERAL PREPARATIONS

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                  PENMIX is a CDMO company specialized in manufacturing and development of Penicillin and General Injectable products. PENMIX is aiming to achieve a goal nof excellence in drug development and globalization of Korean pharmaceutical industry to contribute to such trend.

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                  BioTechnique

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                    HIGH POTENT PRODUCTS

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                    BioTechnique’s facility is designed to handle cytotoxic and highly potent products to both FDA and EU standards

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                    Indar

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                    HUMAN RECOMBINANT INSULIN PRODUCTS

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                    Over 15 years of R&D and experience in medication manufacturing PrJSC Indar has full range of human recombinant insulin products manufactured based on proprietary technology

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                    SENTISS Pharma Pvt. Ltd.

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                    INJECTABLES

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                    Formulation Capabilities Included Injectables

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                    Bahrain Pharma

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                      STERILE LIQUID FILLED VIALS

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                      Sterile Manufacturing facility is at design stage and will have production facility of sterile liquid filled vials, lyophilized vials, oral suspension powders, and injectable liquids could be offered as well as specific techniques such as sterile emulsion technology and pre-filled syringes.

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                      ANFARM HELLAS S.A.

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                        EU GMP COMPLIANT INJECTABLE MANUFACTURING

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                        ANFARM Hellas SA, an EU GMP Pharmaceuticals’ Manufacturer of generic pharmaceuticals with an extended export activity worldwide, through licensing, direct exports and as a third party manufacturer.

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                        BirgiMefar Group

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                        STERILE SOLUTIONS IN BLOW-FILL-SEAL (BFS)

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                        Using state of the art blow-fill-seal (BFS) technology, sterile solutions are filled in plastic containers (5ml - 50ml) with screw-cap or twist-off from 2ml up to 50ml.

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                        Sofarimex

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                          PRODUCTION OF STERILE LIQUID FORMS

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                          Sofarimex is the leader manufacturing company of pharmaceutical products in Portugal. This factory has a large productive flexibility, producing several pharmaceutical forms like solids, liquids, semi-solids & sterile products.

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                          Catalent Pharma Solutions

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                          INJECTABLE DRUG PRODUCT MANUFACTURING

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                          Catalent offers injectable drug product manufacturing, filling & packaging services. They handle small molecules, biologics, & vaccines within their automated filling lines offering the highest degree of aseptic processing.

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                          Delpharm Group

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                          STERILE INJECTABLE MANUFACTURING

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                          Delpharm propose its knowledge and experience to manufacture licensed products, generics, OTC products, dietary supplements, veterinary products, medical devices, highly active and injectable products. Delpharm has a range of equipment to respond to a wid

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                          Biological E

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                          PARENTERAL

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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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                          Cook Pharmica LLC.

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                          ANNUAL CAPACITY OF UPTO 70 MILLION UNITS

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                          The parenteral manufacturing facility at Cook Pharmica can formulate, fill and package your product into a final vial or prefilled syringe presentation, making it ready to use for the patient or administrator.

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                          Orchid Pharma

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                          STERILE PARENTERAL FORMULATIONS

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                          Orchid Pharma's world-class quality products and facilities, regulatory and compliance systems conform to international standards. In fact, they have been the youngest pharmaceutical company in India to receive the coveted ISO Certification.

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                          Farbe Firma

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                          STERILES (LIQUIDS & FREEZE DRIED)

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                          Farbe Firma will supply several hundred of different products in a variety of dosage forms including solid dose, semi solids, steriles (liquids and freeze dried), beta-lactams, hormones, dry powder metered dose inhalers, oral liquids and granulates, from our facilities in nearest future.

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                          Bliss Gvs Pharma Ltd

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                            WHO-GMP CERTIFIED INJECTABLE MANUFACTURING IN AMPOULES

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                            Bliss GVS is a fast-growing Pharmaceutical Company with a proven track record of developing, manufacturing oral syrups. Facility is WHO-GMP approved and can manufacture 12.48 million vials/ annum at one of its units of production.

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                            Biological E

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                            VIALS & PRE-FILLED SYRINGES

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                            Biological E. Limited has invested in building the infrastructure for R&D and manufacturing in Shameerpet, on the outskirts of Hyderabad. The formulation facility will be equipped to handle injectable products in vials and pre-filled syringes.

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                            Oncomed Manufacturing A.S

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                            INJECTIONS IN VIALS

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                            Oncomed is specialized in the production of injections in vials for oncology therapy. It offers production technology in the isolator and conventional clean rooms meeting the latest standards of aseptic manufacturing.

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                            Oncomed Manufacturing A.S

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                            CYTOSTATIC INJECTIONS CONTRACT MANUFACTURING

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                            Oncomed has been manufacturing top quality cytostatic injections suitable for the treatment of patients suffering from oncological diseases.

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                            Axxelent Pharma Science

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                              CONTRACT MANUFACTURING FOR INJECTABLES

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                              Axxelent offers contract manufacturing services for injectable formulations, including freeze-dried powder, liquid vials, pre-filled syringes (PFS), etc. for clinical and commercial purposes.

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                              Madras Pharmaceuticals

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                              CONTRACT MANUFACTURING OF STERILE INJECTABLES

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                              Steril-Gene has 4 major state-of-the-art contract manufacturing facilities for hormonal formulations for sterile liquid injections in ampoules, vials, lyophilized vials and other oral solid dosage forms.

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                              Bioindustria L.I.M. Spa

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                              LARGE & SMALL VOLUME INJECTABLES

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                              Bioindustria L.I.M specializes in large and small volume injectables with terminal sterilization or with aseptic process.

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                              Prague Scientific

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                              CONTRACT MANUFACTURING FOR INJECTABLES

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                              Prague Scientific offers contract manufacturing of parenteral liquid dosage forms, including ampoules and vials.

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                              Mithra CDMO

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                              cGMP CONTRACT MANUFACTURING OF LIQUID INJECTABLES

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                              We provide cGMP manufacturing support in a comprehensive range of batch sizes for liquid injectables, long-acting products and oral forms.

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                              Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                                INJECTABLE MANUFACTURING

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                                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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                                Recipharm AB

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                                CONTRACT MANUFACTURING FOR INJECTABLES

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                                Recipharm has extensive experience in parenterals/injectables manufacturing and supplies small volume parenterals in ampoules and vials, as well as in cartridges.

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                                Adare Pharma Solutions

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                                INJECTABLE MANUFACTURING SERVICES

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                                Stratum® offers controlled and pulse release options in an injectable form and titrates drug release kinetics to enable novel injectable drug delivery products.

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                                Piramal Pharma Solutions

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                                STERILE INJECTABLE MANUFACTURING SERVICES

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                                Piramal offers cGMP manufacturing of a wide range of parenteral drug products including sterile solutions and suspensions (aqueous/non-aqueous) in liquid and lyophilized dosage forms.

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                                Curia

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                                MANUFACTURING OF STERILE DOSAGE FORMS

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                                Curia offers services for the manufacture of sterile dosage forms, including sterile liquids, suspended or lyophilized biological or pharmaceutical products, aseptically filled or terminally sterilised, on a commercial-sized scale.

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                                Eurofins CDMO

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                                STERILE FILL & FINISH SERVICES

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                                Eurofins CDMO offers sterile fill & finish activities for large and small molecule products under full global, GMP-compliance with finished dosage forms according to their customer requirements and drug product specifications.

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                                Legacy Pharmaceuticals Switzerland

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                                  LIQUID INJECTABLES IN AMPOULES AND VIALS

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                                  Legacy Pharmaceutical offers a wide range of possibilities for production and aseptic filling of liquid parenteral dose forms, at multiple filling facilities. Legacy Pharmaceutical is also equipped for thermal final sterilization.

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                                  MediPharm A.S

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                                    CONTRACT MANUFACTURER FOR INJECTABLES

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                                    MediPharm primarily focuses on contract manufacturing of injectables. It offers dry injections into 10-20 ml vials closed with a sterile rubber stopper and liquid injections and infusions aseptically filled in 5-100 ml portions.

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                                    PANPHARMA

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                                    MANUFACTURING OF INJECTABLES

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                                    The Panpharma Group is recognised for its expertise in the development, production & marketing of injectable medicines. We manufacture parenteral liquid forms with the annual production capacity of 120 million units.

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                                    Dalton Pharma Services

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                                      STERILE LIQUID INJECTABLES

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                                      Dalton is a leader in the sterile cGMP manufacture of aseptically filled or terminally sterilized liquid parenteral vials. Batch sizes range from 100’s of vials up to 15,000 vials per batch.

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                                      CDM Lavoisier

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                                        CONTRACT MANUFACTURING FOR INJECTABLES

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                                        For more than 130 years, CDM Lavoisier, has specialized in the development, manufacturing & distribution of sterile injectable products. It can process several parenteral & liquid products, including glass & plastic ampoules along with glass vials.

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                                        Fluart Innovative Vaccines

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                                          FILL & FINISH FOR BIOLOGICAL PRODUCTS

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                                          Fluart Innovative Vaccines is a contract development and manufacturing company that provides fill-and-finish services for biological products.

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                                          Dalton Pharma Services

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                                            STERILE LYOPHILIZED VIALS

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                                            Dalton offers high quality lyophilization services which include cycle optimization and cGMP production for clinical scale batches.

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                                            Aeron Remedies

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                                              CMO FOR INJECTABLE FORMULATIONS

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                                              Aeron Remedies is a leading pharmaceutical manufacturing company in India, dedicated to producing top-quality injectable formulations within GMP-WHO-approved integrated manufacturing facilities.

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                                              Dalton Pharma Services

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                                                STERILE POWDER FILLING IN VIALS

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                                                Dalton specializes in cGMP sterile powder filling into vials. Our unique capability allows us to fill neat sterile powders with suitable flow characteristics into vials in a Class A (100) environment.

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                                                Rafarm S.A

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                                                STERILE PRODUCTS (INJECTION)

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                                                Rafarm produce medicines for more than 50 domestic pharmaceutical companies as well as for most of our clients in Europe and the rest of the world. Within the facility, there is a brand new 1100 m² sterile area for the production of injectable and ophthalmic products.

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                                                Injectalia Srl

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                                                HIGH QUALITY INJECTABLES

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                                                With the new aseptic filling of solutions and diluents in ampoules, Injectalia is also ready to produce high quality injectables at very competitive price.

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                                                Symbiosis Pharmaceutical Services

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                                                  STERILE INJECTABLE PRODUCTS IN VIALS

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                                                  Symbiosis Pharma specialises in the field of sterile filling of pharmaceuticals into vials. Their aseptic filling capabilities cater for the increasing demand for small-scale sterile injectable products.

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                                                  Globela Pharma

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                                                  SMALL VOLUME PARENTERALS MANUFACTURING

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                                                  Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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                                                  Injectalia Srl

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                                                  HORMONAL INJECTABLE PREPARATION

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                                                  Injectalia, after some important investments in new technology, in different segregated buildings, mainly manufactures pharmaceutical products under different forms: Pre-filled syringes, vials, aseptic filling of solutions and diluents in ampoules, etc.

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                                                  Globela Pharma

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                                                  LARGE VOLUME PARENTERALS MANUFACTURING

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                                                  Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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                                                  Jubilant HollisterStier

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                                                  STERILE INJECTABLE FILL/FINISH

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                                                  Jubilant HollisterStier offers 4 high speed commercial vial filling lines. They have two facility: Spokane facility, Montreal facility.

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                                                  Panacea Biotec Limited

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                                                  NANOPARTICLE, MICROPARTICULATE DELIVERY SYSTEMS

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                                                  Panacea's State of art cGMP facility with approvals from global regulatory authorities viz. US FDA, EU agencies, ANVISA, TGA and many other agencies- 3 USFDA Audits cleared, Audit from BfArM Germany cleared.

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                                                  CARBOGEN AMCIS AG

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                                                  GMP COMPLIANT PARENTERAL GRADE OF CYTOTOXIC COMPOUNDS

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                                                  Carbogen Amcis SAS located in Riom, France, focuses on the development and manufacturing of formulation dosages, aseptic filling, and lyophilization of small-molecule APIs, highly-potent APIs and biologics.

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                                                  Atral

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                                                    MANUFACTURING OF INJECTABLES

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                                                    Laboratórios Atral provides contract manufacturing for various pharmaceutical dosage forms such as injectables, oral, semi-solids, in the area of antibiotics, from their facilities dedicated to the production of Penicillins & Cephalosporins.

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                                                    Aesica Pharmaceuticals Limited

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                                                    SYRINGES MANUFACTURING

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                                                    Commercial scale manufacture of liquid products: both terminally sterilised injectables (vials and ampoules) and oral liquids. Blister packaging with fully automated flexible packaging lines and analytical capabilities.

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                                                    PYRAMID Laboratories, Inc

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                                                    VIAL & SYRINGE FILLING

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                                                    PYRAMID’s new state-of-the-art, Aseptic Commercial Manufacturing facility provides fill/finish services for both vial and syringe applications for the Bio-Pharmaceutical industries.

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                                                    Aesica Pharmaceuticals Limited

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                                                    VIALS MANUFACTURING

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                                                    Commercial scale manufacture of liquid products: both terminally sterilised injectables (vials and ampoules) and oral liquids. Blister packaging with fully automated flexible packaging lines and analytical capabilities.

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                                                    Aesica Pharmaceuticals Limited

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                                                    AMPOULES MANUFACTURING

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                                                    Commercial scale manufacture of liquid products: both terminally sterilised injectables (vials and ampoules) and oral liquids. Blister packaging with fully automated flexible packaging lines and analytical capabilities.

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                                                    Basic Pharma

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                                                      PREFILLED VIALS MANUFACTURING

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                                                      Basic Pharma Manufacturing can be your preferred contract manufacturer for your pharmaceutical or biotech products, both investigational medicinal products (IMPs) and commercial products.

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                                                      Pharma Service: Drug Product Manufacturing

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                                                      Aenova Group

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                                                      INJECTABLES: LYOPHILIZATION, TERMINAL STERILISATION

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                                                      Besides cytotoxics and hormones, we also manufacture other special and high-containment products such as beta-lactam antibiotics, tablets, powders, solutions and injection solutions. Injectables: Lyophilization, Aseptic Manufacture, Terminal Sterilisation

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                                                      Pharma Service: Drug Product Manufacturing

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                                                      Siegfried AG

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                                                      COMPLEX STERILE FORMULATION MANUFACTURING

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                                                      Siegfried offers a broad base of know-how in complex oral and sterile formulations of drug products available for custom development and manufacturing (CDMO), and licensing.

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                                                      Softigel Procaps

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                                                      STERILE LIQUID MANUFACTURING

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                                                      Softigel is specialized in Softgel technologies and offer access to other delivery systems such as sterile liquids, injectables, prefilled syringes, creams, ointments, gels, powders, tablets and hard gel capsules.

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                                                      Pharma Service: Drug Product Manufacturing

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                                                      Softigel Procaps

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                                                      INJECTABLE MANUFACTURING

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                                                      Softigel is specialized in Softgel technologies and offer access to other delivery systems such as sterile liquids, injectables, prefilled syringes, creams, ointments, gels, powders, tablets and hard gel capsules.

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                                                      Pharma Service: Drug Product Manufacturing

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                                                      Softigel Procaps

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                                                      PREFILLED SYRINGE (PFS) MANUFACTURING

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                                                      Softigel is specialized in Softgel technologies and offer access to other delivery systems such as sterile liquids, injectables, prefilled syringes, creams, ointments, gels, powders, tablets and hard gel capsules.

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                                                      Pharma Service: Drug Product Manufacturing

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                                                      Siegfried AG

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                                                      INJECTION PREPARATIONS IN AMPOULES & VIALS

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                                                      Our state-of-the-art equipment and development department offers a wide range of the following technologies, and we also offer development of other administration forms (e.g., injection preparations, eye drops, etc.) under non-GMP conditions.

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                                                      Siegfried AG

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                                                      POWDER FOR INJECTION

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                                                      In the critical field of sterile manufacturing where quality is at the highest standard in our industry, Siegfried is your expert in simple and complex formulations at our state-of-the-art facilities located in Hameln (Germany) and Irvine (USA).

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                                                      Siegfried AG

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                                                      INJECTABLE PREPARATIONS OF SMALL MOLECULES

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                                                      Siegfried offers a broad base of know-how in complex oral and sterile formulations of drug products available for custom development and manufacturing (CDMO), and licensing.

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