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    Overview of sterile drug product manufacturing services & more on leading CMOs, CDMOs offering aseptic processing, sterile fill finish, etc.

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    Overview of sterile drug product manufacturing services & more on leading CMOs, CDMOs offering aseptic processing, sterile fill finish, etc.

    Q1. What is a sterile drug product and when is sterile fill-finish required?

    The pharmaceutical industry defines sterile drug products as dosage forms of a drug that are essentially free from living microbes and chemical or physical contamination to the point at which it poses no present risk to the patient, in accordance with regulatory standards.

    Sterile products are administered via an enteral route of administration such as the intravenous, subcutaneous, or intramuscular route. As these complex drug products are infused directly into the bloodstream or body tissue, it is extremely important that they are sterile. Sterile dosage forms include, but are not limited to sterile liquids, parenterals (injectables), surgical irrigants and ophthalmics.

    As sterile dosage forms are intended to be delivered via enteral routes of drug delivery, they bypass various natural defence systems of the body. Therefore it is essential for these pharmaceutical products to undergo sterilization. 

    Sterilization is the use of a physical or chemical procedure to destroy all microorganisms including large numbers of resistant bacterial spores. All sterile drug products have to undergo sterilization before they can be distributed to consumers.

    Sterile fill-finish is the area where a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering of a container happens after, with the exception when a drug requires sterile lyophilization. 

    In sterile fill finish, before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes such as filtration, dry heat sterilization, lyophilization, etc. 

    Fill-finish operations have traditionally been among the most commonly outsourced biopharmaceutical sterile drug product manufacturing activities. Consequently, there are various pharmaceutical organizations, including contract development and manufacturing organizations (CDMOs), that offer the manufacture of sterile pharmaceutical products.


    Sterile fill-finish is required for various reasons, some of them are noted below:

    - Drug products that are delivered via the parenteral, ophthalmic, inhaled, or otic route present an increased risk of infection or harm because they bypass many of the body's natural defenses.

    - To ensure patient safety, the FDA requires that drug products delivered via these routes be supplied as sterile products. 

    - Processes like sterile fill-finish ensure that drug products are sterile and safe for consumption.

    Q2. How are sterile drug products produced by aseptic processing?

    Aseptic processing is defined as the handling of sterile products, containers, and devices in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to maintain sterility. Aseptic processing involves sterile processing techniques, cleanroom facilities, drug product components and container systems, etc. 

    Aseptic processing encompasses various sterile drug manufacturing techniques that go into ensuring that a drug product is free of contaminants, thereby reducing the risk of infection to the patient. It entails the processing of drug components, drug product containers, and excipients in a manner that precludes microbial contamination of the final sealed product.


    - Processes 

    As exposed products are vulnerable to contamination a lot of care needs to be taken when conducting sterile processing techniques. It is imperative to practice good aseptic sterile drug manufacturing techniques and contamination control throughout the manufacture of sterile injectables.

    Aseptic fill finish is the area where a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering of a container happens after, with the exception when a drug requires sterile lyophilization. Alternatively, terminal sterilization is the process of sterilizing a product in its final container. Terminal sterilization is an important process as it ensures the product remains sterile.


    - Cleanroom Facilities

    In simple terms, a cleanroom is a controlled area within a wider facility that maintains a specific level of air particles and other contaminants. A cleanroom is a controlled environment that defines personnel access, levels of contamination, pressurization, and temperature and humidity. The cleanroom suite comprises multiple rooms with varying levels of control.

    Each process could introduce an error that ultimately could lead to the distribution of a contaminated product. Any manual or mechanical manipulation of the sterilized drug, components, containers, or closures prior to or during aseptic assembly poses the risk of contamination and necessitates careful control and cleanroom facilities. 


    - Drug Product Components and Container Systems

    In aseptic processing the drug product, container, and closure are first subjected to sterilization methods separately during aseptic manufacturing, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely controlled environment under current Good Manufacturing Practices. This is referred to as sterile fill finish or aseptic fill and finish. Each of these sterile drug manufacturing techniques requires validation and control.

    Traditional sterile processing techniques allow a final sterile drug product to be achieved by individually sterilizing the containers, material and equipment in-process, resulting in a unified sterilized product. Aseptic processing thus handles components, materials and equipment in such a manner that foreign microbial and endotoxin contamination that exceed predetermined acceptable levels, are not introduced to the product stream.

    Q3. What are the control strategies for the manufacturing of sterile pharmaceutical products?

    A control strategy for manufacturing sterile pharmaceutical products and substances sets out a documented approach and rationale taken to control a product's quality and efficacy as well as patient safety. An effective strategy takes various factors into consideration. 

    These factors may include the type of pharmaceutical product being manufactured, microbial contamination, sterility assurance, facility design, chemical contamination, particle contamination, viral control and other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations. 

    Pharmaceutical organizations, such as a CDMO or CMO, which offers sterile manufacturing services have extensive experience in producing sterile pharmaceutical formulations. They incorporate the above given controls into their sterile manufacturing service offerings. 


    Some Control Strategies for the Manufacturing of Sterile Pharmaceutical Products:


    - Manufacturing Control Strategy 

    A manufacturing control strategy for sterile products depends on the product type, demand, process and risk associated with it. The manufacturing control strategy should identify a defined approach on how a specified level of control will be achieved and implemented during the sterile manufacturing process.


    - Contamination Control

    Contamination control is another important parameter when it comes to the manufacture of sterile pharmaceutical products. A contamination control strategy requires a holistic identification, assessment, control and monitoring process for contamination risks that include microbiological, particulate, chemical and cross product contamination.


    - Microbial Control Strategy for Environmental Control

    A comprehensive microbial control program should identify the risk of contamination to the product as well as the different mitigation steps to control this risk. The systems used to control the environment of the facility are qualified prior to running operations and are part of the facilities' life cycle.


    - Quality Control

    Quality control measures are important for the manufacture of sterile pharmaceutical products. Ineffective quality control during sterile manufacturing can result in substandard injectable products, contaminated products or products that do not meet required sterility standards. Furthermore, it could result in inadequate packaging and reduced quality.

    Q4. Which are the leading pharmaceutical CMOs for injectable drug product manufacturing?

    As noted above, various CDMOs and CMOs offer the production of sterile products such as parenteral sterile solutions and emulsions and services such as aseptic manufacturing, sterile fill-finish or aseptic fill and finish, etc.


    Leading CDMOs and CMOs Offering Injectable Drug Product Manufacturing Services:


    Madras Pharmaceuticals - Sterile Drug Product Manufacturing

    Steril-Gene is a joint venture between Madras Pharma and Lloyd Laboratories. It has 4 major state-of-the-art manufacturing facilities for hormonal formulations, sterile liquid injection in ampoules, parenteral sterile solutions and emulsions, vials, lyophilized vials and other oral solid dosage forms.

    Madras Pharma is capable of developing, scaling up and commercializing various dosage forms like tablets, capsules, soft gels and injectable drug delivery systems. Its strengths and capabilities include parenteral injections and lyophilized powders.


    Catalent Pharma Solutions - Injectable Drug Product Manufacturing 

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


    Eurofins CDMO - Aseptic Fill and Finish Services 

    Eurofins CDMO offers sterile fill and finish activities for large and small molecule products according to their customer's requirements and drug product specifications. 

    Eurofins CDMO offers current Good Manufacturing Practices (cGMP) compliant sterile manufacturing or aseptic manufacturing services to support lyophilized complex drug products. They also offer formulation transition from liquid to freeze-dried form (sterile liquids), freeze drying cycle development for HPAPI and cytotoxics up to OEL 4, BSL 2 products, etc.


    Pfizer CentreOne - Sterile Drug Product Manufacturing

    Pfizer CentreOne is a global provider in contract development and manufacturing for small molecule APIs, large molecule biologics, oral solids and sterile injectables, and is a leading supplier of specialty APIs and intermediates.

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


    Recipharm AB - Sterile Drug Product Manufacturing

    Recipharm has extensive experience in parenterals and injectables manufacturing and supplies small volume parenterals in ampoules and vials, as well as in cartridges. Recipharm's full service offering is compliant with current Good Manufacturing Practices (cGMP) for lyophilization, terminal sterilization, aseptic processing, etc.


    Quotient Sciences - High-potency Injectable Manufacturing

    Quotient Sciences has responded to the challenges associated with the manufacturing of high-potency injectable complex drug products by ensuring their facilities are capable of handling compounds with a maximum performance-based level of exposure classification.

    Its facility in Miami, Florida has been built to support rapid and cost-effective dose preparations including oral solutions, suspension, sterile dosage forms, parenteral sterile solutions and emulsions, etc.

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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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    ASEPTIC FILL & FINISH SERVICES

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    Famar

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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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    Polfa Tarchomin

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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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    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

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    Quotient Sciences

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    CLINICAL SUPPLY OF PARENTERALS

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    Quotient Sciences offers clinical trial manufacturing services for parenteral dosage forms [intravenous (IV), intramuscular (IM) and subcutaneous (SC)].

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    Clinical Supply of Parenterals

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    Temad Co

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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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    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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      CMO for Injectables

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      Fareva

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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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      Sterile Drug Product Manufacturing

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      Fareva

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      PRE-FILLED SYRINGE CONTRACT MANUFACTURING

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      Fareva manufactures a wide range of pharmaceutical formulations including pre-filled syringes, freeze-dried products, sterile gels, and ointments. It has 18 sites with state-of-the-art technologies that offer packaging solutions for sterile drug products.

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      Pre-filled Syringe Contract Manufacturing

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      Fareva

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      HIGHLY POTENT INJECTABLE MANUFACTURING

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      Fareva is a CDMO that offers highly potent injectable formulations and pre-filled syringes (PFS). It also provides a wide range of sterile, biological, and freeze-dried products.

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      Highly Potent Injectable Manufacturing

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      Sharp

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      STERILE FILL & FINISH IN VIALS & SYRINGES

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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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      Sterile Fill & Finish in Vials & Syringes

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      Astral SteriTech

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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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      Evonik

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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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      Complex Parenteral Drug Product Manufacturing

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      Aurigene Pharmaceutical Services

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      LIQUID & LYOPHILIZED INJECTIONS

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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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      Aurigene Liquid & Lyophilized Injections

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      Ethypharm

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      CONTRACT MANUFACTURING FOR INJECTABLES

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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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      Contract Manufacturing for Injectables

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      Ethypharm

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      AMPOULE & PFS CONTRACT MANUFACTURING

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      Ethypharm’s broad range of injectable formulations covers pre-filled syringes (PFS) and ampoules. Its CDMO services include contract manufacturing, terminal sterilization, and aseptic filling of PFS and glass ampoules.

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      Ampoule & PFS Contract Manufacturing

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      TriRx Pharmaceutical Services

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      STERILE FORMULATION CONTRACT MANUFACTURING

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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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      TriRx Pharmaceutical Services Sterile Formulation Contract Manufacturing

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      Biopharma Group

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        FREEZE DRIED & LIQUID FORMULATIONS IN VIALS

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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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        Freeze Dried & Liquid Formulations in Vials

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        Gensenta Pharmaceuticals

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        ASEPTIC FILL & FINISH SERVICES

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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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        Category: Injectable / Parenteral

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        Aseptic Fill & Finish Services

        CPhI Worldwide, Milan

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        AbbVie Contract Manufacturing

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        PREFILLED SYRINGE CONTRACT MANUFACTURING

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        AbbVie is a contract manufacturing organization offering fill-finish of lyophilized & liquid products in sterile syringes & vials. It also provides all the necessary elements for delivering high quality parenteral products for clinical & commercial needs.

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        Pharma Service: Drug Product Manufacturing

        Category: Injectable / Parenteral

        Sub Category: Pre-Filled Syringe

        Prefilled Syringe Contract Manufacturing

        BIO Int. Convention

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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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        Pharma Service: Drug Product Manufacturing

        Category: Injectable / Parenteral

        Sub Category: Overview

        Centrient Company Banner

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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

        Category: Injectable / Parenteral

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        CMO for Complex Parenteral Drug Products

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        Evonik

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        CLINICAL MANUFACTURING OF PARENTERALS

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        Evonik offers cGMP clinical and commercial manufacturing for a range of parenteral drug products, including microparticles, nanoparticles, implants, and its aseptic filling into vials as powders, liquids and suspensions.

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        Pharma Service: Drug Product Manufacturing

        Category: Injectable / Parenteral

        Sub Category: Clinical Supply

        Clinical Manufacturing of Parenterals

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        Biopharma Group

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          STERILE FORMULATION CLINICAL MANUFACTURING

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          Biopharma Group has flexible lines to suit a range of vials and vessels and provides sterile batch manufacturing under GMP conditions. Its state-of-the-art facility supports the transition of drug candidates from R&D into early-stage clinical manufacture.

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          Sub Category: Clinical Supply

          Biopharma Sterile Formulation Clinical Manufacturing

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          Astral SteriTech

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          PENICILLIN INJECTABLE FORMULATIONS

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          Astral offers contract manufacturing for sterile antibiotic powder injectable formulations. They have independent and dedicated facilities to manufacture injectable formulations for the cephalosporin and penicillin group of products.

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          Pharma Service: Drug Product Manufacturing

          Category: Injectable / Parenteral

          Sub Category: Beta Lactams

          Centrient Company Banner

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          Evonik

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          ASEPTIC FILLING OF HIGHLY POTENT PRODUCTS

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          Evonik offers aseptic filling services that occur in ISO 5 (Grade A) isolators, with facilities designed for use with highly potent products (> 0. 1 ug / m3) and controlled substances (Schedule III-V).

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          Pharma Service: Drug Product Manufacturing

          Category: Injectable / Parenteral

          Sub Category: High Potency APIs (HPAPIs)

          Aseptic Filling of Highly Potent Products

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          Biopharma Group

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            ASEPTIC FILLING OF CYTOTOXIC PRODUCTS

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            Biopharma Group's sterile fill and finish services include aseptic filling of cyto and non-cyto products and flexible lines to suit a range of vials and vessels. Its lyophilization facilities are designed to accommodate up to 20R vials.

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            Pharma Service: Drug Product Manufacturing

            Category: Injectable / Parenteral

            Sub Category: High Potency APIs (HPAPIs)

            Aseptic Filling of Cytotoxic Products

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            Evonik

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            ASEPTIC FILLING OF CONTROLLED SUBSTANCES

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            Evonik offers aseptic filling services that occur in ISO 5 (Grade A) isolators, with facilities designed for use with controlled substances (Schedule III-V) and highly potent products (> 0. 1 ug / m3).

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            Pharma Service: Drug Product Manufacturing

            Category: Injectable / Parenteral

            Sub Category: Controlled Substance

            Aseptic Filling of Controlled Substances

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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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            Pharma Service: Drug Product Manufacturing

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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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            Pharma Service: Drug Product Manufacturing

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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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              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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                  S.C. Rompharm Company SRL

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                    GMP MANUFACTURING OF PRE-FILLED SYRINGES

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                    S.C. Rompharm manufactures in compliance with Romanian law no 95/2006 regarding medicines for human use and has Valid Manufacturing Authorization, in full compliance with GMP issued by the National Medicine and Medical Devices Agency.

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                    Category: Injectable / Parenteral

                    Sub Category: Pre-Filled Syringe
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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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                    Pharma Service: Drug Product Manufacturing

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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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                    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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                      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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                      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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                      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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                      Curida AS

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                        CONTROLLED DRUGS

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                        With our specialization in liquid manufacturing and expert know-how, we can provide investigational medicinal products (IMPs) for clinical studies. Curida’s facilties are suitable and fully equipped to handle controlled drugs.

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                        Sub Category: Controlled Substance
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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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                          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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                          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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                            SENTISS Pharma Pvt. Ltd.

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                            INJECTABLES

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                            Formulation Capabilities Included Injectables

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                            Orofino Pharmaceuticals Group

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                            QDC-PREFILLED SYRINGES IN DOUBLE CHAMBER

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                            BIOPHARMA, a leading beta lactams antibiotics contract manufacturing facility, is approved by the Italian Authority for oral & injectable formulations & by the FDA for injectable dosage forms. Biopharma produces QDC-prefilled syringes in double chamber.

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                            Sub Category: Pre-Filled Syringe
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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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                            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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                                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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                                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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                                  BirgiMefar Group

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                                  PARENTERAL SOLUTIONS IN PRE-FILLED SYRINGES

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                                  Parenteral solutions are filled in ready to fill syringes (polypropylene or glass) of 1ml up to 50ml.

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                                  Pharma Service: Drug Product Manufacturing

                                  Category: Injectable / Parenteral

                                  Sub Category: Pre-Filled Syringe
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                                  ScinoPharm Taiwan, Ltd

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                                  HPAPI / CYTOTOXICS INJECTABLE MANUFACTURING

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                                  ScinoPharm provides one-stop-shop service for our existing API customers. The company also adopts Double A (API+ANDA) business model to team up with Pharma companies' to apply for ANDA in US/EU and export final drug products globally.

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                                  Category: Injectable / Parenteral

                                  Sub Category: High Potency APIs (HPAPIs)
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                                  Orofino Pharmaceuticals Group

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                                  MANUFACTURING OF CORTICOSTEROIDS FDF

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                                  Certified by AIFA, FDA, Injectalia serves as CMO for small sterile liquids medicinal finished products such as Corticosteroids.

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                                  Category: Injectable / Parenteral

                                  Sub Category: Steroid / Hormone
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                                  Cook Pharmica LLC.

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                                  PREFILLED SYRINGE FILLING

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                                  Cook Pharmica’s parenteral contract manufacturing facility includes a syringe filling line with an annual capacity of up to 70 million syringes. Fully enclosed in a barrier isolator, it offers the highest level of CGMP aseptic processing available.

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                                  Sub Category: Pre-Filled Syringe
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                                  Bahrain Pharma

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                                    FILLING PROCESSES FOR PREFILLED SYRINGES

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                                    Bahrain offers filling processes for 2, 3, 5, 10 & 20 ml syringes. Their annual capacity is calculated around 48 million prefilled syringes. Sterile prefilled syringes are produced with an aseptic filling machine at 10,000 units/hour.

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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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                                    Fresenius Kabi Austria

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                                      STERILE PHARMACEUTICALS FOR CLINICAL TRIALS

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                                      Sterile pharmaceuticals for clinical trials, Besides manufacturing complex aqueous solutions, a set of homogenizers enable us to manufacture emulsions, liposomal formulations and suspensions from 5 L up to 1000 L.

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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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                                        HIGHLY POTENT INJECTABLES MANUFACTURING

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                                        Oncomed's bio fill finish services are available for different actives such as cytotoxic, cytostatic, non-cytotoxic High potent APIs (OEB 4, OEB 5), etc.

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                                        Sub Category: High Potency APIs (HPAPIs)
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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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                                        Oncomed Manufacturing A.S

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                                        CLINICAL SUPPLY FOR INJECTABLES

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                                        Oncomed – A contract development and manufacturing organization (CDMO) – is specialized in aseptic processing of oncology injectables for clinical and commercial supply.

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                                        Sub Category: Clinical Supply
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                                        Eurofins CDMO

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                                        HPAPI / CYTOTOXICS INJECTABLE MANUFACTURING

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                                        Eurofins CDMO offers integrated development services through the entire drug product life cycle, from highly potent active pharmaceutical ingredients (HPAPI) forward.

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                                        Sub Category: High Potency APIs (HPAPIs)
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                                        Orofino Pharmaceuticals Group

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                                        CMO FOR BETA LACTAM INJECTABLES

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                                        Biopharma serves as CMO for Betalactam finished products such as penicillins (sterile vials, prefilled syringes, tablets, capsules, sachets), cephalosporins (sterile vials) and carbapenems (sterile vials, QDC-Prefilled syringes in double chamber).

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                                        Sub Category: Beta Lactams
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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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                                          Ropack Inc

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                                            LICENSED FOR CONTROLLED SUBSTANCE MANAGEMENT- INJECTABL...

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                                            With a wide variety of manufacturing processes, Ropack Pharma Solutions provides versatility in design and manufacture of solid oral dosage.

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                                            Category: Injectable / Parenteral

                                            Sub Category: Controlled Substance
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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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                                              Mithra CDMO

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                                              CLINICAL SUPPLY MANUFACTURING

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                                              Mithra offers tailored clinical manufacturing services to ensure a successful launch of your clinical trial: we develop your product according to your technical requirements within your timeframe.

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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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                                              Piramal Pharma Solutions

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                                              CLINICAL & COMMERCIAL SUPPLY OF INJECTABLES

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                                              Piramal offers clinical & commercial manufacturing of liquid & lyophilized formulations. It provides sterile solutions & suspensions (aqueous/non-aqueous), nanoparticles and liposomes, liquid and lyophilized dosage forms.

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                                              Sub Category: Clinical Supply
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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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                                              Curia

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                                              CONTROLLED SUBSTANCE INJECTABLE MANUFACTURING

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                                              Curia offers sterile drug product manufacturing for controlled drugs (schedule I to V), monoclonal antibodies, antibody-drug conjugates and proteins or peptides.

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                                              Category: Injectable / Parenteral

                                              Sub Category: Controlled Substance
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                                              Curia

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                                              CLINICAL SUPPLY OF INJECTABLES

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                                              Curia leverages its expertise and capabilities to manufacture sterile drug products at any scale, from early clinical through large-scale commercial supply.

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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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                                              Eurofins CDMO

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                                              MANUFACTURING FOR STERILE INJECTABLES

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                                              Eurofins CDMO offers sterile manufacturing services to support lyophilized drug products. They also offer formulation transition from liquid to freeze dry form, freeze drying cycle development for HPAPI and cytotoxics up to OEL 4, BSL 2 products, etc.

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                                              Category: Injectable / Parenteral

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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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                                                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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                                                  Jubilant HollisterStier

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                                                  CTM STERILE FILLING CAPABILITIES

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                                                  The Clinical Trial Manufacturing (CTM) area at our Spokane facility is available for production of Phase I through commercial material with 2,100 ft2 of production space.

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                                                  CordenPharma

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                                                  PREFILLED SYRINGE (PFS) MANUFACTURING

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                                                  CordenPharma’s Injectable manufacturing covers both Terminal Sterilization and Aseptic Filling Technologies for Pre-filled Syringes (PFS), Vials, Ampoules and Lyophilized Vials, with a wide range of filling volumes.

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                                                  IRISYS, LLC

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                                                    PREFILLED SYRINGE (PFS) MANUFACTURING

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                                                    IRISYS’ capabilities as a syringe contract manufacturer includes syringe filling contract manufacturing services via which they produce pre-filled syringes to their clients’ specifications.

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                                                    Aqua Vitoe Laboratories

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                                                      MANUFACTURING OF BETA LACTAM INJECTABLES

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                                                      Aqua Vitoe Laboratories offers contract manufacturing for offering various Beta Lactam & Non-Beta Lactam injectable formulations. They have capacity to produce 2 Lac dry powder injections (Penicillin) per day and 1.70 Lac general injections per day.

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                                                      Sub Category: Beta Lactams
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                                                      ZOETIS

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                                                      CONTRACT MANUFACTURING - PACKAGING

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                                                      Zoetis offers a range of contract manufacturing & packaging options; including vaccines & sterile liquids (aseptic & terminal sterilization) in many different presentations (glass & plastic vials, prefilled syringes), non-sterile liquids & pastes, etc.

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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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                                                        Ciron Drugs & Pharmaceuticals Pvt. Ltd

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                                                        PRE-FILLED SYRINGE CONTRACT MANUFACTURING

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                                                        Ciron is eager to fulfill your contract manufacturing requirements. We offer contract manufacturing to client's across the globe. Ciron's high production capacities include pre-filled syringes 25,000 units per shift.

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                                                        Italfarmaco S.p.A

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                                                        PRE-FILLED SYRINGE CONTRACT MANUFACTURING

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                                                        The Italfarmaco plant has been manufacturing pre-filled syringes since 1987 and over the years it has acquired a remarkable experience and skills thanks to the constant industrial investment in the most sophisticated and updated technologies.

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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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                                                        Pharma Service: Drug Product Manufacturing

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                                                        Akums Drugs & Pharmaceuticals Ltd

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                                                        INJECTABLE DOSAGE FORMS & PREFILLED SYRINGES

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                                                        Akum's contract manufacturing facilities are equipped with modern equipment & machinery for manufacturing formulations in a range of dosage forms; tablets, hard & soft gel capsules, dry & liquid syrups, dry & liquid injectables, prefilled syringes, etc.

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                                                        Pharma Service: Drug Product Manufacturing

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                                                        Sub Category: Pre-Filled Syringe
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                                                        Vetter Pharma-Fertigung GmbH & Co

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                                                          PRE-FILLED SYRINGE CONTRACT MANUFACTURING

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                                                          A strategic partner focused on your success Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges and vials.

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                                                          Sub Category: Pre-Filled Syringe
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                                                          Injectalia Srl

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                                                          PREFILLED SYRINGE CONTRACT MANUFACTURING

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                                                          Today Injectalia, after some important investments in new technologies, in segregated buildings, mainly manufactures pharmaceutical products under different formulations such as pre-filled syringes.

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                                                          Polifarma

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                                                            PRE-FILLED SYRINGE (PFS) MANUFACTURING

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                                                            Polifarma has the capability of manufacturing products in LVP (PP/PVC bag, PP/glass bottle), SVP (vial, liquid/lyophilized ampoule, PP bag), PFS (Pre-filled syringe) at the same time in Turkey.

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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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                                                              Italfarmaco S.p.A

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                                                              CLINICAL SUPPLY

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                                                              Italfarmaco is authorized by the Italian Medicines Agency (AIFA) to the manufacturing of prefilled syringes, ampoules with terminal sterilization and the major oral solid forms both for clinical trials and business supplies.

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                                                              Biopharma Srl

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                                                                QDC-PREFILLED SYRINGES IN DOUBLE CHAMBER

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                                                                BIOPHARMA, a leading beta lactams antibiotics contract manufacturer, has global & skilled experience in contract manufacturing services. The facility, located in Santa Palomba, is approved by the Italian Authority for oral and injectable dosage forms.

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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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                                                                  NovaCina

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                                                                    HIGHLY POTENT INJECTABLE MANUFACTURING

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                                                                    NovaCina is a CDMO that offers aseptic and terminally sterilized potent injectable formulations. It provides high potency and cytotoxic products in PP, clear, and amber-colored vials with volumes ranging from 1-100 mL and batch sizes from 15 L to 1,180 L.

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                                                                    Pharma Service: Drug Product Manufacturing

                                                                    Category: Injectable / Parenteral

                                                                    Sub Category: High Potency APIs (HPAPIs)
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                                                                    PANPHARMA

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                                                                    EXPERTISE IN NARCOTICS

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                                                                    Panpharma offers a range of narcotics (“controlled drugs”) and ensures complete traceability of products from the raw material to the finished product and end hospital.

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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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                                                                      Jubilant HollisterStier

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                                                                      AUTOMATIC STERILE FILLING CAPABILITIES

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                                                                      The Clinical Trial Manufacturing (CTM) area at there Spokane facility is available for production of Phase I through commercial material with 2,100 ft2 of production space.

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                                                                      Pharma Service: Drug Product Manufacturing

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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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                                                                        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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                                                                        Cyndea Pharma S.L

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                                                                          CONTRACT MANUFACTURING-HIGH ACTIVITY PARENTERAL PRODUCT

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                                                                          Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.

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                                                                          Pharma Service: Drug Product Manufacturing

                                                                          Category: Injectable / Parenteral

                                                                          Sub Category: High Potency APIs (HPAPIs)
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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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                                                                          PREFILLED SYRINGES, VIALS & AMPOULES

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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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                                                                          Dalton Pharma Services

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                                                                            CLINICAL STERILE VIAL MANUFACTURING

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                                                                            Dalton offers a selection of in-stock vial container closure options and commonly used excipients to deliver your aseptic clinical materials faster in full compliance.

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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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                                                                              Symbiosis Pharmaceutical Services

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                                                                                INJECTABLE PRODUCTS FOR CLINICAL SUPPLY

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                                                                                Symbiosis Pharma specialises in sterile fill-finish of vials for clinical trials.Their aseptic filling capabilities cater for the increasing demand for small-scale sterile injectable products for use in clinical trials or licensed commercial supply.

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                                                                                GBI

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                                                                                  ASEPTIC FILL & FINISH

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                                                                                  GBI provides customized, economical & compliant liquid filling of your products in cGMP conditions to support human clinical trials in the US, EU and Asia. Both Manual & Automated Aseptic filling validated for 400-2000 vials of 1-10mL volumes per vial.

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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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                                                                                  Labiana Pharmaceuticals

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                                                                                  AUTHORISED MANUFACTURING FOR HORMONALS

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                                                                                  LABIANA GROUP has two plants for manufacturing its own products as well as products for third parties.

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                                                                                  Category: Injectable / Parenteral

                                                                                  Sub Category: Steroid / Hormone
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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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                                                                                  Biovian

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                                                                                    ASEPTIC FILL-FINISH OF DRUG PRODUCTS FOR CLINICAL TRIAL

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                                                                                    Biovian has expertise in very complex dosing requirements and aseptic processes. Biovan offers full service from fill and finish to labelling and QP-release of Drug Products for clinical trial purposes.

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                                                                                    Cyndea Pharma S.L

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                                                                                      EYEDROP CLINICAL TRIAL BATCHES

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                                                                                      Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.

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                                                                                      Cyndea Pharma S.L

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                                                                                        PREFILLED SYRINGES / VIALS CLINICAL TRIAL BATCHES

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                                                                                        Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.

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                                                                                        Pharma Service: Drug Product Manufacturing

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                                                                                        Sub Category: Clinical Supply
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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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                                                                                        Pharma Service: Drug Product Manufacturing

                                                                                        Category: Injectable / Parenteral

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                                                                                        Labiana Pharmaceuticals

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                                                                                        AUTHORISED MANUFACTURING FOR PSYCHOTROPICS

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                                                                                        LABIANA GROUP has two plants for manufacturing its own products as well as products for third parties.

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                                                                                        Pharma Service: Drug Product Manufacturing

                                                                                        Category: Injectable / Parenteral

                                                                                        Sub Category: Controlled Substance
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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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                                                                                        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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                                                                                        Pharma Service: Drug Product Manufacturing

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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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                                                                                          Pharma Service: Drug Product Manufacturing

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                                                                                          Aesica Pharmaceuticals Limited

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                                                                                          CONTROLLED DRUGS INJECTABLES MANUFACTURING

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                                                                                          MHRA, EU, FDA, Korean FDA, PMDA, ANVISA, ROW, QP release, possession of controlled drugs and manufacture of controlled drugs.

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                                                                                          Pharma Service: Drug Product Manufacturing

                                                                                          Category: Injectable / Parenteral

                                                                                          Sub Category: Controlled Substance
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                                                                                          PYRAMID Laboratories, Inc

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                                                                                          CLINICAL MANUFACTURING

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                                                                                          PYRAMID’s Aseptic Sterile Clinical Manufacturing services include formulation, processing, and filling capabilities for Pre-clinical, stability studies, and Clinical for both vial and syringe applications for the Biotech and Pharmaceutical industries, for all regulatory phases.

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                                                                                          Cyndea Pharma S.L

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                                                                                            HORMONE INJECTABLE MANUFACTURING

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                                                                                            Cyndea Pharma bases its activities upon the manufacturing and development of steroid based generic drugs.

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                                                                                            Pharma Service: Drug Product Manufacturing

                                                                                            Category: Injectable / Parenteral

                                                                                            Sub Category: Steroid / Hormone
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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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                                                                                            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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                                                                                            Pharma Service: Drug Product Manufacturing

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                                                                                            PYRAMID Laboratories, Inc

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                                                                                            INJECTABLES IN VIALS

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                                                                                            PYRAMID’s Aseptic Sterile Clinical Manufacturing services include formulation, processing, and filling capabilities for Pre-clinical, stability studies, and Clinical for both vial and syringe applications for the Biotech and Pharmaceutical industries, for all regulatory phases.

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                                                                                            Pharma Service: Drug Product Manufacturing

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                                                                                            Sub Category: Clinical Supply
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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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                                                                                            Pharma Service: Drug Product Manufacturing

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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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                                                                                            Pharma Service: Drug Product Manufacturing

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                                                                                            Basic Pharma

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                                                                                              PREFILLED SYRINGES MANUFACTURING

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

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                                                                                              Pharma Service: Drug Product Manufacturing

                                                                                              Category: Injectable / Parenteral

                                                                                              Sub Category: Pre-Filled Syringe
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                                                                                              PYRAMID Laboratories, Inc

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                                                                                              VIALS & PRE-FILLED SYRINGES

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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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                                                                                              Pharma Service: Drug Product Manufacturing

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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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                                                                                                Bluepharma

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                                                                                                HIGH POTENCY PRODUCTS - PARENTERALS

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                                                                                                Bluepharma performs its activity from product development to the end of the value chain, that is, finished product supply.

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                                                                                                Pharma Service: Drug Product Manufacturing

                                                                                                Category: Injectable / Parenteral

                                                                                                Sub Category: High Potency APIs (HPAPIs)
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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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                                                                                                Labiana Life Sciences S.A

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                                                                                                AUTHORISED MANUFACTURING FOR HORMONALS

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                                                                                                LABIANA GROUP has two plants for manufacturing its own products as well as products for third parties.

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                                                                                                Pharma Service: Drug Product Manufacturing

                                                                                                Category: Injectable / Parenteral

                                                                                                Sub Category: Steroid / Hormone
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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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                                                                                                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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                                                                                                Labiana Life Sciences S.A

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                                                                                                AUTHORISED MANUFACTURING FOR PSYCHOTROPICS

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                                                                                                LABIANA GROUP has two plants for manufacturing its own products as well as products for third parties.

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                                                                                                Pharma Service: Drug Product Manufacturing

                                                                                                Category: Injectable / Parenteral

                                                                                                Sub Category: Controlled Substance
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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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                                                                                                Pharma Service: Drug Product Manufacturing

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                                                                                                Siegfried AG

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                                                                                                PRE-FILLED SYRINGES

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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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                                                                                                Pharma Service: Drug Product Manufacturing

                                                                                                Category: Injectable / Parenteral

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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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                                                                                                Pharma Service: Drug Product Manufacturing

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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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