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    Why Selection of a Contract Manufacturing Organization (CMO) for HPAPI Development is Necessary? Highly potent active pharmaceutical ingredients (HPAPIs) are the compounds used extensively today for the treatment of respiratory disorders, cancer and hormonal imbalances. The key factors driving the demand for highly potent active pharmaceutical ingredients (HPAPIs) are the rise in the oncology therapeutics market as well as the surge in the need for better medicines for treating Cardiovascular, C

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    Seqens

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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
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    HPAPI CONTRACT MANUFACTURING

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    Seqens is a contract development and manufacturing organization that offers highly potent and oncology APIs with OEB 4 and 5 (1µg/m3) levels. It is involved in the production of clinical and lab to full commercial scales of potent molecules.

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    Pharma Service: API Manufacturing

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    HPAPI Contract Manufacturing

    CPhI North America

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    Minakem

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    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    HPAPI CONTRACT MANUFACTURING

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    Minakem offers state-of-the-art high containment manufacturing facility for highly potent APIs from early-stage development to scale-up and commercial manufacturing. It can handle HPAPIs with OEL below 0.1μg/m³/shift (OEB class 6).

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    Pharma Service: API Manufacturing

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    HPAPI Contract Manufacturing

    CPhI North America

    Booth #1210

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    Gentec Pharmaceutical Group

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    Virtual BoothGentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
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    CONTRACT MANUFACTURING FOR HPAPIs

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    Gentec's Duke Chem and Pharmanoid plant offers manufacturing services for high potency active pharmaceutical ingredients (HPAPIs) and APIs under the contract manufacturing modality.

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    CONTRACT MANUFACTURING FOR HPAPIs

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    Polpharma

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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    HPAPI MANUFACTURING

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    Polpharma API CDMO has a highly specialized area and is involved in the development and manufacturing of highly potent APIs (HPAPIs). It has a new greenfield research & development and production facility dedicated to HPAPI products with OEL 1-10 µg/m3.

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    HPAPI Manufacturing

    CPhI North America

    Booth # 814

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    Pfizer CentreOne

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    Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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    CONTRACT MANUFACTURING FOR LIQUID CYTOTOXICS

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    Pfizer offers contract manufacturing expertise for potent drugs, liquid cytotoxics, biologics, small molecules, controlled substances (II-IV), liposomal, inactivated vaccines, monobactam, hormones, steroids & prostaglandins.

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    Contract Manufacturing for Liquid Cytotoxics

    CPhI North America

    Booth #1142

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    Malladi Drugs & Pharmaceuticals Limited

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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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    HPAPI MANUFACTURING SERVICES

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    Malladi has specialized facilities and systems for high potency active pharmaceutical ingredients (HPAPIs). Its facilities can support manufacturing volumes ranging from a kilo to multi-ton levels.

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    Malladi Drugs HPAPI Manufacturing Services

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    Fermion Oy

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    HPAPI CONTRACT MANUFACTURING SERVICES

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    Fermion is a CDMO with manufacturing expertise in highly potent APIs, high-quality cytotoxics with three fully automated HPAPI modules for OEB5 (0,1 - 1 µg/m3) classified APIs with reactors of 250 L, 400 L and 600 L.

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    HPAPI Contract Manufacturing Services

    CPhI North America

    Booth #1117

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    Veranova

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    Virtual BoothVeranova: A CDMO that manages complexity with confidence.
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    HPAPI CONTRACT MANUFACTURING

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    With an increasing number of new drugs under development containing highly potent APIs (HPAPIs), Veranova is able to combine its extensive technical expertise with specialized equipment to produce HPAPIs (SafeBridge®4) with OEL as low as 1 μg/m3.

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    Veranova HPAPI Contract Manufacturing

    CPhI North America

    Booth #536

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    Aspen API

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    HIGHLY POTENT API MANUFACTURING

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    Aspen API strengths lie in manufacturing APIs at various production scales with a specialization in HPAPIs. The chemical capabilities offer containment capability for manufacturing and handling HPAPI products from OEL 1 ug/m³ to 50 ng/m³.

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    Highly Potent API Manufacturing

    CPhI North America

    Booth #548

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    AbbVie Contract Manufacturing

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    Virtual BoothAbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.
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    MANUFACTURING OF HIGHLY POTENT APIs (HPAPIs)

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    AbbVie's Sligo facility is a dedicated cGMP plant for manufacturing highly potent chemical APIs and oral solid drug products. It is capable of handling potent compounds with containment levels up to OEB 5 (OEL <1μg/m3).

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    Manufacturing of Highly Potent APIs (HPAPIs)

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    Fareva

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    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
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    CMO FOR HIGH POTENCY APIs (HPAPIs)

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    Fareva is a leading CDMO with three production sites for high potency APIs, intermediates, sterile APIs and cytotoxic compounds. It produces several tons of APIs per year on a large scale.

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    CMO for High Potency APIs (HPAPIs)

    CPhI North America

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    Aarti Pharmalabs

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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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    HPAPI CONTRACT MANUFACTURING

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    Aarti Pharmalabs is a leading CDMO that offers contract development and manufacturing services for various drug substances such as high-potency active pharmaceutical ingredients (HPAPIs), including anti-cancer and cytotoxic compounds.

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    Aarti HPAPI Contract Manufacturing

    CPhI China

    Booth #E1C28

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    Evonik

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    Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
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    CMO FOR HIGH POTENCY APIs (HPAPIs)

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    Evonik is the world’s largest contract manufacturing organization with more than 20 years of expertise in high-potency APIs. It has a total HPAPI capacity of 170m³, with reactors up to 7,600 liters in capacity.

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    CMO for High Potency APIs (HPAPIs)

    EMWA 2024

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    Aurigene Pharmaceutical Services

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    Virtual BoothAurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.
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    HPAPI MANUFACTURING SERVICES

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    Aurigene Pharmaceutical Services has cGMP isolator systems (up to OEL 0.1µg/m³) for highly potent raw materials, intermediates and API manufacturing. It offers manufacturing of HPAPIs and other complex substances from gram to multi-kilogram quantities.

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    Aurigene HPAPI Manufacturing Services

    Iran Expo

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    Axplora

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    Virtual BoothAxplora- The partner of choice for complex APIs.
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    HPAPI CONTRACT MANUFACTURING

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    Axplora offers a full range of high-potency API (HPAPI) manufacturing services. It also has great expertise in the development, scale-up, and handling of cytotoxics and highly active compounds with an OEL below 10 ng/m³.

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    HPAPI CONTRACT MANUFACTURING

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    Medichem S.A

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

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    Medichem produces Class 4 HPAPIs with OEL down to 40 ng/m³ in its state-of-the-art cGMP facilities.

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    HPAPI Contract Manufacturing

    CPhI North America

    Booth #644

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    Egis Pharmaceuticals PLC

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    Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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    HIGHLY POTENT API MANUFACTURING

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    Egis Pharmaceuticals has GMP production lines that can handle 1 g/m3 < OEL < 10 g/m3 (OEB4) levels of highly potent APIs. It also produces HPAPIs for formulation experiments, clinical trials, and commercial purposes with an annual capacity of ca. 600 kg.

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    Pharma Service: API Manufacturing

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    Highly Potent API Manufacturing

    euroPLX Dublin

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    Cerbios-Pharma SA

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    HPAPI DEVELOPMENT & COMMERCIAL PRODUCTION

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    Cerbios offers CDMO services for HPAPIs from clinical to commercial, providing cGMP manufacturing of molecules from a few grams up to 35 kg/batch with containment according to SafeBridge® Cat. 3 and 4 (OEL < 30 ng/m3).

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    Magle Chemoswed

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    HIGHLY POTENT COMPOUNDS

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    Magle Chemoswed performs multi-step synthesis and is an expert in handling highly potent compounds according to cGMP standards.

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    DOTTIKON EXCLUSIVE SYNTHESIS AG

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    HIGHLY POTENT API (HPAPI) MANUFACTURING

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    To handle active substances, DOTTIKON has state-of-the-art containment concepts on all scales (e.g. closed charging/handling/discharging, full protection suit, monitoring, WIP/CIP cleaning, and cleaning validation).

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    Fresenius Kabi Austria

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      HIGH-POTENT API (HPAPI)

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      High-potent APIs, a special pharma lab was commissioned in 2008 in order to develop and manufacture pharmaceuticals with APIs up to an OEL level of 4.

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      Mac-Chem Products (India) Pvt.Ltd

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      HIGH POTENCY API (HPAPI) MANUFACTURING

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      Mac-Chem has a containment facility of isolators and glove box technology for manufacturing of highly potent cytotoxic pharmaceutical substances with capabilities from gram level to kilo level.

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      Dishman Carbogen Amcis

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      HIGHLY POTENT API (HPAPI) MANUFACTURING

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      The Dishman Group offers unparalleled capabilities in scale-up, development and commercial manufacture of highly potent APIs (HPAPIs) and vitamins. All its facilities operate under cGMP conditions.

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      Ash Stevens, Inc.

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      HIGH POTENCY APIs (HPAPIs)

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      Ash Stevens is a leader in the development and cGMP manufacture of high potency active pharmaceutical ingredients (HPAPIs).

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      ScinoPharm Taiwan, Ltd

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      HIGH POTENCY CYTOTOXICS INJECTABLE APIs

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      ScinoPharm provides a one-stop-shop service for its existing API customers. The company also adopts a 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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      ChemCon GmbH

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      CONTRACT MANUFACTURING FOR HIGHLY POTENT APIs

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      ChemCon is a contract development and manufacturing organization (CDMO) that offers highly potent active pharmaceutical ingredients (HPAPIs), cytotoxic compounds and controlled substances.

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      Arevipharma

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      HANDLING OF HIGHLY POTENT COMPOUNDS

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      Arevipharma offers three state-of-the-art, multi-purpose plants with a total reactor volume capacity of 150 m3, which comply with the cGMP standards and meet almost all customer requirements.

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      Procos

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      HIGH POTENCY API MANUFACTURING

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      Procos has established a new state-of-the art facility to develop and manufacture high potency APIs (HPAPIs) and intermediates, with dedicated facilities from R&D to cGMP production.

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      Angelini Pharma

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      HIGHLY POTENT API (HPAPI) MANUFACTURING

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      Angelini Fine Chemicals has a High Potency API Synthesis unit extending its manufacturing capabilities with a new cGMP manufacturing unit fully dedicated to the development and small- and mid-scale cGMP manufacturing of custom high containment APIs.

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      Piramal Pharma Solutions

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      HPAPI CONTRACT MANUFACTURING

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      Piramal offers various manufacturing services for high potent APIs (HPAPIs), key starting materials (KSMs), registered starting materials (RSMs), key GMP intermediates and commercial-scale APIs.

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      Curia

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      MANUFACTURING OF HIGHLY POTENT COMPOUNDS

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      Curia has 30 years of experience in the production, handling and containment of highly potent and cytotoxic compounds. It has expertise in the cGMP production of highly potent compounds, from a few grams to hundreds of kilograms per year.

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      Eurofins CDMO

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      HIGH POTENT APIs (HPAPI) MANUFACTURING

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      Eurofins CDMO offers integrated contract manufacturing services through the entire drug product life cycle, including highly potent active pharmaceutical ingredients (HPAPIs). Its cGMP manufacturing facilities can handle highly potent APIs.

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      CARBOGEN AMCIS AG

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      CONTAINMENT FACILITIES TO PRODUCE HPAPIs

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      CARBOGEN AMCIS' containment facilities are designed based on a containment concept utilizing barrier isolation technology and Rapid Transfer Ports (RTPs) as well as a strict zone concept with pressure cascades, airlocks and access controls.

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      Indena

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      CMO FOR HPAPIs

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      Indena is the world’s leading company in the identification, development and production of plant-derived active principles for the pharmaceutical, health-food and personal care industries.

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      Olon S.p.A

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      HIGH POTENCY DRUGS

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      High potency compounds, as well as cytotoxic substances, are well accommodated in specialized high containment facilities.

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      Pfanstiehl

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      HIGH POTENCY SUBSTANCE MANUFACTURING

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      Pfanstiehl is motivated by a concern for both product quality and environmental/worker safety. We design and equip our plant, write our procedures and train our people to meet or exceed US FDA, cGMP, OSHA and international regulatory standards.

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      Aesica Pharmaceuticals Limited

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      HIGH POTENCY API MANUFACTURING

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

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      Cambrex Corporation

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      HIGH POTENCY API MANUFACTURING

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      Cambrex offers customers an end-to-end partnership for the research, development & manufacture of small molecule APIs at every stage of the life cycle. Cambrex has been developing & manufacturing a broad spectrum of HPAPIs and compounds for >15 years.

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      Farmhispania

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      HPAPI

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      HPAPI, Farmhispania Group has recently opened a kilo-HPAPI area where we have two lines with vessels from 10 to 63 L, including Aurora filter and a tray drier.

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      Farmhispania

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      KILO-HPAPI

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      For HPAPI, Farmhispania Group has recently opened a kilo-HPAPI area where we have two lines with vessels from 10 to 63 L, including Aurora filter and a tray drier.

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      Evotec

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      MANUFACTURING HIGHLY POTENT COMPOUNDS

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      A notable aspect of Evotec’s API capabilities is the ability to manufacture highly potent compounds as well as manufacture and distribute controlled substances. Use, manufacture and supply of controlled substances to Schedule 1

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      Servier

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      HIGH POTENCY API HANDLING- GRAMS TO TONS

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      Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs (HPAPIs). Its full cGMP / FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support.

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      Farmhispania

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      HIGHLY POTENT FERMENTATION CAPABILITIES

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      Farmhispania's Zaragoza site includes complete equipment to the upstream and downstream parts of the fermentation process, from small scale to large scale production. Currently we are carrying out aerobic fermentation of complex potent products.

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      Stason Pharmaceuticals, Inc.

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      HIGH CONTAINMENT OPERATIONS

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      Our analytical testing labs are furnished with appropriate equipment such as safety workbenches for sample preparations, containment hoods and isolators for testing samples, and separation from the normal lab areas and with limited access.

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      Ardena

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        MANUFACTURING OF HIGH POTENT APIs

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        Ardena’s drug substance unit has capabilities & expertise in manufacturing highly potent drug substance, including steroids. Their production facility has containment capabilities that comply with occupational exposure band C (0.1-1 mg/m3) requirements.

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        Siegfried AG

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        HIGH POTENCY MATERIALS

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        We offer an extensive range of chemistries & process capabilities at production scale to efficiently manufacture demanding drug substances, intermediates and complex synthetic processes. Among the range of materials produced are controlled substances and high potency materials.

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        Siegfried AG

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        HIGH CONTAINMENT FACILITIES AND CAPABILITIES

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        The increasing trend seen for active pharmaceutical ingredients (API) currently under worldwide development is towards ever higher potency levels and pharmacological activity. Such increased compound potency involves, however, associated potential occupational health hazards.

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