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    What Are the Salient Features of HPAPIs CMOs / CDMOs for Development of HPAPIs as Capsules? 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, Central Nervous System, Hormonal, Eye, Infectious, Metabolic and Inflammatory diseases. A growing number of approved pharmaceutical drugs contain high-potency active pharmaceutical ingredients (HPAPIs), which has led to an explosive growth in demand for the production of HPAPIs using state of the art development methods of Highly Active Pharmaceutical Ingredients (HAPI) whilst adhering to cGMP guidelines. Another reason why the demand for HPAPIs is thriving is because of advances in clinical pharmacology. There is particular interest in HPAPI–antibody conjugate technology, which uses monoclonal antibodies to selectively deliver HPAPIs to specific cancer tumors. When conjugated to the antibody, the HPAPI targets cancer cells specifically and thereby spares non-target cells many of the toxic effects. One of the earliest examples is Mylotarg (gemtuzumab ozogamicin), which is commercialized for treating acute myeloid leukemia. Although this emerging market is attractive, it presents a significant challenge for pharmaceutical manufacturers to upgrade existing facilities that are set up to handle only non-potent APIs—the challenge being the major cost associated with the specialized containment needed to ensure that employees and their environment are protected from exposure. Many contract manufacturers are also building new facilities that are designed specifically for the manufacture of HPAPIs, which require an investment of millions of dollars beyond typical GMP (good manufacturing practices) High Potency Product Manufacturing facilities. This investment may include specialized facilities for HPAPI–antibody conjugations that incorporate handling of all forms high potent APIs biologics (HPAPI capsules, HPAPI ADCs, HPAPI biologics etc.) processing capabilities. Highly active or potent pharmaceutical ingredients (HPAPIs) comprise different compounds, but share one deadly characteristic: the potential to inhibit production of specific enzymes and cause cancer, mutations, development effects, or sickness, at very low doses, in those exposed to them. While there is an upsurge in the number of types of HPAPIs, it is important to keep in mind the essential attributes of HPAPI biologics. Highly potent drug product manufacturers are developing more potent drugs, and despite the lack of specific environmental and safety regulations, HPAPIs have become fertile ground for contract manufacturing and contract development and manufacturing organizations (HPAPI CMOs and CDMOs), which have been actively building up capacity over the past few years. However, a systematic and scientific approach is needed. Simply having containment equipment and basic procedures will not be enough to ensure safety. Highly Potent Drug Products: Manufacturing, Challenges and Scope of Future Growth Typically, large pharmaceutical companies have the industrial hygienists and occupational toxicologists on staff to evaluate the potential risks of any new HPAPI, and to conduct the necessary safety assessments. Potent API Contract Manufacturing at smaller companies and CDMOs/CMOs may not have all types of staff experts. Teams that visit potential oral solid dose highly potent manufacturing partners may be so focused on cGMP guidelines and product specifications that may overlook worker safety and environmental risk from exposure to HPAPIs. In addition, HPAPI CDMOs / HPAPI CMOs may not have done a sufficiently thorough assessment to determine whether they can handle a potent new drug safely. Failure to vet potential partners thoroughly can lead to regulatory problems with the Occupational Health and Safety Administration (OSHA), United States and potential legal liability. HPAPI Encapsulation Capacity Plays a Big Role in Developing HPAPI Capsules A high quality encapsulation capacity for highly potent active pharmaceutical ingredient (HPAPI) manufacturing services is vital for development of HPAPIs as capsules or tablets. High Potent Oral Solid Dose Formulation processes involve processing an adequately maintained set of containment valves offers a proven method for the transfer of powder, granular and semi-solid ingredients within GMP manufacturing of cytotoxic, antibiotics and hormonal therapies ensuring the safe handling of a wide range of ingredients: • Highly Potent Active Ingredients (HPAPI) • Seed • Intermediates • Tablets • Capsules The processes involved in HPAPI manufacturing and HPAPI handling for production of HPAPIs as Capsules are: 1. Dispensing 2. Vessel Charging 3. Filtration / Drying 4. Sieving 5. Milling 6. Sampling Critical containment performance targets and other key process requirements are realized with specialized oral solid dose highly potent manufacturing valves using a range of options and accessories. Additionally, high containment of highly potent solid oral drugs to Nanogram levels is an important step for HPAPIs manufacturing especially in oral solid dose highly potent manufacturing. Critical containment and high volume containment performance involves the following processes: 1. Manual or fully automated operation 2. Washing and Cleaning in Place (WIP, CIP) 3. Nitrogen purging 4. In-line sampling Manufacture of all oral drug product dosage forms used as targeted therapies has to be customized so that they can be administered in much lower doses because they are distributed within the body to a specific site of action, rather than systemically. Side effects are also significantly reduced. Highly Potent Oral Solid Dosage drugs – those with occupational exposure limits (OELs) of < 1 ?g/m3 – also require much lower doses. Antibody-drug conjugates (ADCs) are both highly targeted and highly potent and consequently have received significant attention from bio/pharmaceutical manufacturers. Contract development and manufacturing organizations (CDMOs) specialized in developing highly potent solid oral drugs with established track records in the successful development, scale-up and commercialization of highly potent small-molecule APIs, biologic drug substances and formulated products are benefitting from the growing number of ADCs in development. All steps can be performed for development of highly potent solid oral drugs, starting from dispensing to film coating, in an engineering controlled environment. The Application of Highly Potent APIs in Different Types of Therapies is Expanding Fast The overall scope for highly potent active pharmaceutical ingredients as biologics (HPAPI biologics) is expanding at a healthy pace, in large part due to the production of Antibody-drug conjugates (HPAPI ADCs). Some estimates suggest that approximately 25% of drugs on the market today are formulated with Cytotoxic and High Potency drug substances. Although these products require huge manufacturing investments, the scope of demand for oral solid dose highly potent manufacturing at HPAPI CMOs / HPAPI CDMOs has been rising at about 10% per year. While small-molecule high-potency compounds currently account for the largest percentage of sales as far as HPAPI CMOs are concerned, the biologic HPAPIs segment, including highly potent solid oral drugs (HPAPI capsules), and ADCs, is the most lucrative and can grow up to a high compound annual growth rate (CAGR) of 14.7% from 2015 to 2022. Increasing numbers of generic HPAPIs will drive growth in this segment as well. Regionally, North America currently accounts for the greatest percentage of sales ($4.5 billion in 2014) for Highly Potent Oral Solid Dosage drugs, but the highest growth rate (14.0%) will be seen in Asia Pacific. Most HPAPIs are intended as anti-cancer therapies (including ADCs), but there are many highly potent compounds developed for other therapeutic applications, such as diabetes, cardiovascular disease and central nervous system and musculoskeletal disorders. Nearly 290 small molecule targeted therapies in development for the treatment of cancer will be delivered as biologic HPAPIs. There are also large numbers of highly potent biologic drugs (HPAPI biologics) – including antibodies and ADCs, among others, that are in the pharmaceutical industry pipeline. Examples of biologic HPAPIs that are not classified as oncology drugs include hormones, narcotics, and retinoids. HPAPI CMOs and HPAPI CDMOs Are the Trailblazers of the HPAPI drug development revolution The manufacture of highly potent compounds requires specialized facilities, equipment, operating procedures and operator skills and training. In addition, because of the limited doses required for HPAPIs, generally only relatively small volumes of HPAPI biologic drug substances and formulated HPAPIs are needed. As a result, investment by branded HPAPI biologics drug manufacturers, and particularly small oral solid dose highly potent manufacturing partners has been in the high level of specialized equipment and expertise often is not economically viable. While some large pharmaceutical companies have invested in in-house capabilities, most have elected to outsource the development and manufacture of HPAPIs and formulated potent drugs to contract service providers. For oral solid dosage forms based on highly potent APIs, rigorous care must be taken throughout the production process (granulation, mixing, tableting, etc.) to ensure the highest level of quality. Shielding operators from exposure to these highly potent drugs is paramount. Initially, for operator protection, the emphasis was placed on the use of extensive personal protective equipment (PPE), but more recently, it has shifted to the use of contained equipment and automation. Various pharma majors already utilize or plan to acquire specialized, HPAPI research, development and/or manufacturing capabilities from CDMOs. In addition, nearly 40% use or plan to use CDMOs for potent packaging activities. HPAPI Drug manufacturers also rely heavily on CDMOs that offer specialized technologies for enhancement of the delivery of potent compounds (BCS Class II – IV compounds including peptides). The most popular services in this area are the development of controlled release formulations and excipients that enhance bioavailability. Specific production capabilities of interest include solvent-capable rotor and rotor-fluidized bed processing, as well as Wurster column bead drying, layering and coating. Globally, CMOs / CDMOs with High Potency Product Manufacturing capacity are focused on Highly Potent Oral Solid Dosage / HPAPI manufacturing; approximately 40% of their 130-plus production facilities are dedicated to manufacturing of both HPAPI capsules and cytotoxic drugs. Many have recently expanded their capabilities, including Capsugel, Idifarma, Labochim, Medichem, OPKO Health, ScinoPharm, WuXi PharmaTech and Fermion, among others. Since, 2006, more than 100 investments involving the addition of new facilities and / or expansion of existing capacities have happened to scale up operations in dedicated HPAPI CMOs. In addition, the market research firm notes that over 15% of CMOs/CDMOs have established comprehensive services in order to support both HPAPI and formulated cytotoxic drug manufacturing. Examples include AbbVie, AMRI, Baxter, Corden Pharma and Fareva. Challenges are numerous in the Manufacture of all oral drug product dosage forms: Not only the potency and cytotoxicity of HPAPIs pose challenges to HPAPI manufacturing, the low dosages often require specialized formulating technologies such as liquid fill hard HPAPI capsules (LFHC) and soft gelatin HPAPI capsules, to ensure that drug delivery occurs appropriately. Facilities must have controlled airflow (single-pass) and pressure systems with filtration capabilities, airlocks and vestibules around both laboratory and manufacturing suites. The use of isolators and automated handling equipment is increasingly common as a means for effectively minimizing the potential for exposure of operators and the environment to Potent API Contract Manufacturing. Industrial hygiene and extensive operators training programs are also essential. Appropriate facilities, engineering controls and safety protocols during Cytotoxics and High Potency Manufacturing are increasingly imperative as newer HPAPIs as capsules under development have ever declining OELs. These very low exposure levels create further challenges with respect to analysis and the need for ever higher levels of containment. Highly Potent Oral Solid Dosage products are processed to produce ADCs pose additional manufacturing challenges. Not only are both biopharmaceutical and chemical manufacturing capabilities needed, the ability to conjugate highly potent small-molecule APIs to biologic components is required along with Highly Potent Formulation Oncology expertise. As importantly, the conditions used to ensure safety and sterility conflict while potent api contract manufacturing is underway. Sterility of biopharmaceuticals including Highly Potent Oral Solid Dosage capsules is typically achieved by using positive pressure to prevent any contaminants from entering the production area. When working highly potent solid dosage manufacturing, however, negative pressure is utilized to reduce exposure to operators. One approach to this problem is to dissolve the HPAPI in a separate isolator in a different room that is under negative pressure. Once in solution the risk of exposure via airborne contamination is reduced, and thus the remaining production steps – conjugation of the payload to the antibody, purification and final formulation / filling can be performed in other areas under positive pressure. It is also essential to ensure that no free small-molecule HPAPI remains in the final ADC product following conjugation of the payload to the antibody. Any residual high-potency drug substance left in the product following the final purification step could pose a significant safety risk for patients. Risk management guides decisions in facility design and operation for highly potent drugs. Risk management is always a priority in highly potent solid dosage manufacturing. With highly potent drugs, the level of risk management required is even higher. For oral solid dosage forms based on highly potent APIs, rigorous care must be taken throughout the production process (granulation, mixing, tableting, etc.) to ensure the highest level of quality. Shielding operators from exposure to these highly potent drugs is paramount. Initially, for operator protection, the emphasis was placed on the use of extensive personal protective equipment (PPE), but more recently, it has shifted to the use of contained equipment and automation. With exposure of operators a real concern, separating them from the drug product is critical. “The real equipment breakthrough for the manufacture of highly potent solid dosage drugs in terms of both safety and efficiency has come in the form of automation.

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    Skyepharma

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    HIGHLY POTENT TABLET MANUFACTURING

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    Skyepharma excels in developing and manufacturing classic and complex oral dosage forms, including highly potent (OEB4+) tablets, immediate-, controlled- and modified-release tablets, etc.

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    HIGH POTENCY CAPSULE MANUFACTURING

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    Skyepharma excels in developing and manufacturing classic and complex oral dosage forms, including highly potent (OEB4+) capsules, modified release and coated capsules, and capsules filled with tablets and granules.

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    HPAPI DEVELOPMENT & MANUFACTURING

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    Polpharma API is a CDMO that has a highly specialized area for the development and manufacturing of high-potency APIs (HPAPIs). It has a new greenfield R&D and production facility dedicated to HPAPI products with OEL 1-10 µg/m3.

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    CDMO FOR HIGH POTENCY APIs (HPAPIs)

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    Minakem is a CDMO that offers contract development and manufacturing solutions for the synthesis of HPAPIs (Highly Potent Active Pharmaceutical Ingredients) and intermediates at all production scales.

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    Quotient Sciences has a state-of-the-art containment manufacturing facility to handle high potency products, which features isolator technology and engineered controls.

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    High Potency Drug Product Manufacturing

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    Gentec Pharmaceutical Group

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    Gentec's Pharmanoid plant is dedicated to the development of HPAPIs including several prostaglandins for ophthalmic use. It has facilities which are certified for cGMP compliance that allow the handling of HPAPIs with containment.

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    Fermion, through its mother company Orion, offers contract manufacturing services for capsules and tablets with expertise in highly potent, high-quality cytotoxics manufacturing.

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    Fermion's R&D laboratory contains 55 fume hoods & has special laboratory spaces for hydrogenation & highly potent APIs (HPAPI). Fermion’s Oulu site focuses on smaller volume highly potent OEB5 APIs from a scale of 1-2kg per batch to one metric ton.

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    Established in 1982, Orion has acquired long-term expertise in manufacturing highly potent & high-quality cytotoxics. The focus areas of its drug product contract manufacturing services include cytotoxic oral solids, such as tablets and capsules.

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    Veranova combines its extensive technical expertise with specialized equipment for the development and production of highly potent active pharmaceutical ingredients (SafeBridge®4).

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    Aspen API is a CDMO offering development and up-scaling of complex high potency APIs (HPAPIs). It offers containment capabilities for manufacturing and handling HPAPI products from OEL 1 ug/m³ to 50 ng/m³.

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    Mikart

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    Mikart offers various non-sterile liquid options to fit your needs. It can take your product from formulation development through full-scale commercial production with capabilities including controlled substances (CII – CV), solutions & suspensions.

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    Fareva

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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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    CDMO FOR HPAPIs

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    Fareva has more than three decades of experience in the development and manufacturing of active ingredients and pharmaceutical products. Its API range includes highly potent (HPAPIs), sterile, controlled substances, and cytotoxics.

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    CDMO for HPAPIs

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    Bora Pharmaceuticals

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    HIGH POTENCY ORAL DRUG PRODUCT MANUFACTURING

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    Bora has decades of experience in manufacturing and packaging a wide range of Rx and OTC OSD drug products, including high-potency and modified-release drug products. It offers OSD manufacturing at its manufacturing facilities in Asia and North America.

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    Aarti Pharmalabs

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    CDMO FOR HPAPIs

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    Aarti Pharmalabs is a leading CDMO that offers contract development and manufacturing services for various drug substances such as HPAPIs, including anti-cancer and cytotoxic compounds, along with steroid APIs.

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    Aarti CDMO for HPAPIs

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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

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    Aseptic Filling of Highly Potent Products

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    Evonik

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    Evonik is the industry’s largest HPAPI process developer and manufacturer for more than 20 years with a total reactor capacity of 170m³. It has a cGMP suite for the small-scale production of HPAPI and ultra-HPAPI.

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    Pharma Service: API & Drug Product Development

    Category: API Development

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    Development of High Potency APIs (HPAPIs)

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    Seqens

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    HPAPI DEVELOPMENT SERVICES

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    Seqens offers custom drug substance development services, including HPAPI containment down to 100 ng/m3. It has the capability to develop APIs with a high level of confinement up to OEB 4 and OEB 5.

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    Pharma Service: API & Drug Product Development

    Category: API Development

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    HPAPI Development Services

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    Aurigene Pharmaceutical Services

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    HPAPI DEVELOPMENT SERVICES

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    Aurigene Pharmaceutical Services is experienced in providing end-to-end solutions in high-potent API (HPAPI) development and manufacturing (up to OEL 0.1µg/m³) for over two decades.

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    Category: API Development

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    Aurigene Pharmaceutical Services HPAPI Development Services

    Chinaplas 2024

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    Axplora

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    HPAPI DEVELOPMENT SERVICES

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    Axplora is a CDMO that offers high-potency API development services. Its Le Mans site located in France, and Gropello site in Italy, offer process development and cGMP production of highly potent APIs (HPAPIs) and cytotoxic APIs.

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    HPAPI DEVELOPMENT SERVICES

    Chinaplas 2024

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    Famar

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    HIGH POTENT TABLET MANUFACTURING

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    Famar offers the manufacturing and packaging of high potent tablets at its dedicated unit in Alcorcon, Spain. It provides round and oblong tablets as well as single-layer tablets.

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    Category: Tablet

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    High Potent Tablet Manufacturing

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    Douglas CDMO

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    HIGHLY POTENT DRUG PRODUCT MANUFACTURING

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    Douglas CDMO specializes in the development and commercial manufacturing of cytotoxic and highly potent solid oral dosage forms. It offers a variety of highly potent products, including light-sensitive retinoids, hormones, cytotoxics & immunosuppressants.

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    Douglas Pharmaceuticals Highly Potent Drug Product Manufacturing

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    Ethypharm

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    HIGH POTENCY CAPSULE CONTRACT MANUFACTURING

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    Ethypharm is specialized in the contract manufacturing of high potency capsules and tablets. Its state-of-the-art facilities are equipped with advanced oral solid dosage technologies that provide the development and manufacturing of potent formulations.

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    Pharma Service: Drug Product Manufacturing

    Category: Capsule

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    High Potency Capsule Contract Manufacturing

    15th Global DDF Summit

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    Ethypharm

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    MANUFACTURING OF HIGHLY POTENT TABLETS

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    Ethypharm has over four decades of experience in the manufacturing of highly potent (oncology, orphan drugs) tablets and capsules. It is a CDMO specialized in the development and manufacturing of complex and narcotic oral solid dosage forms.

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    Category: Tablet

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    Manufacturing of Highly Potent Tablets

    15th Global DDF Summit

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    Biopharma Group

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      HIGHLY POTENT & CYTOTOXIC LIQUIDS

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      Biopharma Group is a contract development and manufacturing organization (CDMO) that has extensive experience in handling sensitive highly potent (HPAPI) and cytotoxic liquids with three dedicated Category D, low bio-burden labs and one cytotoxic suite.

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      Highly Potent & Cytotoxic Liquids

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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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        Category: Injectable / Parenteral

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        Aseptic Filling of Cytotoxic Products

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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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        CDMO FOR HIGHLY POTENT DRUG SUBSTANCES

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        Egis Pharmaceuticals has cutting-edge infrastructure for the contract development of traditional and highly potent (HP) drug substances. It involves the synthesis and scale-up to a maximum 15 L volume with OEB4 classification 1 g/m3 < OEL < 10 g/m3.

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        CDMO for Highly Potent Drug Substances

        euroPLX Dublin

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        Gensenta Pharmaceuticals

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        HIGHLY POTENT LIQUID PRODUCTS

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        Gensenta has a dedicated cGMP plant for manufacturing highly potent chemical APIs and liquid and lyophilized sterile products. It is capable of handling potent compounds with containment levels up to OEB 5 (OEL <1μg/m3).

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        Pharma Service: Drug Product Manufacturing

        Category: Liquid

        Sub Category: High Potency APIs (HPAPIs)

        Highly Potent Liquid Products

        CPhI Worldwide, Milan

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        Nutrasource

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          ANALYTICAL TESTING SERVICES FOR APIs

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          Nutrasource is a CRO offering analytical solutions & clinical trial services. It provides contract services for bioanalytical & analytical testing including analytical method development, stability & purity testing, large molecules, API testing, etc.

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          Anthem Biosciences

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          HIGHLY POTENT API (HPAPI) SYNTHESIS

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          Anthem Biosciences offers synthesis of high potent APIs (HPAPIs) – up to OEB 5 along with toxin conjugates, ADCs, peptides, PEG, Gal-NAc, conjugated steroids and phospholipids.

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          Cerbios-Pharma SA

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          DEVELOPMENT & COMMERCIAL PRODUCTION OF HPAPIs

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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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          APC Ltd

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            HIGH POTENCY LAB

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            APC Ltd. has a dedicated laboratory and infrastructure servicing the needs of clients with highly potent synthetic molecules including beta lactams.

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            Category: API Development

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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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            ChemCon GmbH

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            CDMO FOR HPAPIs

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            ChemCon offers development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs), cytotoxic compounds and controlled substances.

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            Category: API Development

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            QUINTA-ANALYTICA s.r.o

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            ANALYSIS OF HIGHLY POTENT SUBSTANCES

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            We use our Highly Potent Substance Laboratory (HPSL) for highly potent products like cytostatics hormones and antibiotics within a hygienic loop, equipped with dedicated equipment and specially trained personnel.

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            Angelini Pharma

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            DEVELOPMENT OF HIGHLY POTENT APIs (HPAPIs)

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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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            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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            Category: Injectable / Parenteral

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            Piramal Pharma Solutions

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            HPAPI DEVELOPMENT & MANUFACTURING SERVICES

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            Piramal is a global leader in the development & manufacturing of high-potent compounds. It has over five decades of experience in HPAPI services with process research, development, optimization and scale-up as well as cGMP manufacturing.

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            Category: API Development

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            Eurofins CDMO

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            HPAPIs / CYTOTOXICS TABLET MANUFACTURING

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            Eurofins CDMO's state-of-the-art dedicated cGMP facilities are equipped and contained to offer diverse range of High Potency API development manufacturing solutions both in early as well as late stage development programs.

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            Procos

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            DEVELOPING & MANUFACTURING HIGH POTENCY APIs

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            Procos has the facilities to develop & manufacture hi-potency APIs & intermediates, with dedicated facilities from R&D to cGMP production: 2 Operation Units for HPAPI small scale manufacturing: up to 5 Kg batches; High containment: down to 30 ng/m3; etc.

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            Curia

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            DEVELOPMENT OF HIGHLY POTENT APIs

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            Curia offers development of high-potency APIs and DEA-licensed controlled substances. 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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            HIGHLY POTENT APIs CAPSULE

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

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            Category: Capsule

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            Procos

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            ANALYTICAL & GMP RELEASE TESTING FOR HPAPIs

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            Procos has established new state-of-the art facility to develop and manufacture High potent APIs and intermediates (HPAPI), with dedicated facilities from R&D to cGMP production: 2 Operation Units for HPAPI small scale manufacturing: up to 5 Kg batch; High containment: down to 30 ng/m3; etc.

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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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            DOTTIKON EXCLUSIVE SYNTHESIS AG

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            CONTAINMENT OF HIGH POTENCY API (HPAPI)

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

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            Category: API Development

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            Arbro Pharmaceuticals Pvt. Ltd

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              POTENT COMPOUND CONTAINMENT MONITORING PROGRAM

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              We had Arbro has been supporting numerous clients for their containment monitoring programs. We have established and validated analytical procedures for quantifying numerous beta-lactam, cephalosporin and other potent drugs at ultra trace levels in slab and air samples using LCMSMS.

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              Zenvision Pharma LLP

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                HIGH POTENT MOLECULES (ONCOLOGY, HORMONES ETC.)

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                Zenvision has expertise to do the plant setups (concept to commissioning) as per international regulatory compliance.

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                APC Ltd

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                  HIGHLY POTENT API

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                  APC Ltd. has a dedicated laboratory and infrastructure servicing the needs of clients with highly potent synthetic molecules including beta lactams.

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                  Madras Pharmaceuticals

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                  CONTRACT MANUFACTURING OF HIGH POTENT TABLETS

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                  Steril-Gene Life Sciences's world class state of the art manufacturing facility provides contract manufacturing & outsourcing solutions for potent molecules such as tablets & capsules to various pharmaceutical companies across the world.

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                  Catalent Pharma Solutions

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                  HIGHLY POTENT CAPSULES

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                  Catalent offers integrated analytical, development & manufacturing services for highly potent products such as capsules & tablets. Catalent’s long history of expertise in handling high potent molecules includes hormones and cytotoxics.

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                  Pharma Service: Drug Product Manufacturing

                  Category: Capsule

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                  Catalent Pharma Solutions

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                  HIGHLY POTENT TABLETS

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                  Catalent offers analytical, development & manufacturing services for highly potent products such as tablets & capsules. Catalent also recently invested in its Somerset, NJ headquarters as a Center of Excellence for oral solid potent manufacturing.

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                  Pharma Service: Drug Product Manufacturing

                  Category: Tablet

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                  Piramal Pharma Solutions

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                  HIGHLY POTENT ORAL LIQUID FORMULATIONS

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                  Piramal can help you safely & efficiently turn your HPAPI project into a success. It specializes in formulating highly toxic compounds, such as cytotoxics, hormones, HPAPIs & controlled substances, into safe & effective oral liquids & solid dosage forms.

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                  Eurofins CDMO

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                  DEVELOPMENT OF HPAPIs

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                  Eurofins CDMO offers integrated development services through the entire drug product life cycle for highly potent active pharmaceutical ingredients (HPAPIs). Their R&D and analytical facilities are equipped to handle HPAPIs up to SafeBridge Class IV.

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                  Piramal Pharma Solutions

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                  HPAPI TABLET MANUFACTURING

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                  Piramal specializes in formulating highly toxic compounds, such as HPAPIs, controlled substances, cytotoxics and hormones, into safe & effective oral solid dosage forms.

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                  Pharma Service: Drug Product Manufacturing

                  Category: Tablet

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                  NovaCina

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                    CYTOTOXIC & HIGHLY POTENT LIQUID FORMULATIONS

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                    As an end-to-end provider of pharmaceutical manufacturing solutions, NovaCina is equipped to supply broad cytotoxic and potent liquid drug production services. It offers ready-to-use liquid formulations in vials with volumes ranging from 1 mL to 100 mL.

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                    Category: Liquid

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                    Aesica Pharmaceuticals Limited

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                    CAPABILITY TO HANDLE HIGHLY POTENT DRUGS

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                    Aesica has the ability to perform process development and scale-up rapidly, including the capability to handle potent and controlled drugs.

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                    Pharma Service: API & Drug Product Development

                    Category: API Development

                    Sub Category: High Potency APIs (HPAPIs)
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                    Cyndea Pharma S.L

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                      CONTRACT MANUFACTURING OF HIGH ACTIVITY TABLET 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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                      Cyndea Pharma S.L

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                        CONTRACT MANUFACTURING OF HIGH ACTIVITY CAPSULE 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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                        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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                          Category: Injectable / Parenteral

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                          V-Nano

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                            CONTRACT DEVELOPMENT & MANUFACTURING OF HPAPI

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                            V-Nano aims to become the leading European CDMO for precision therapies. It manages the complete pharmaceutical development of a wide range of APIs such as cytotoxic or high potency API (HPAPI), conventional API, large & small molecules.

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                            Pharma Service: API & Drug Product Development

                            Category: API Development

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                            CordenPharma

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                            LIQUID HIGHLY POTENT DRUG PRODUCTS

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                            CordenPharma’s Highly Potent & Oncology platform utilizes state-of-the-art high containment technology and processes to manufacture Highly Potent Active Pharmaceutical Ingredients (APIs) and drug products including Injectables (liquid and lyophilized).

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                            Category: Liquid

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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

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                              CARBOGEN AMCIS AG

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                              HPAPIs FROM PRE-CLINICAL TO COMMERCIAL SCALE

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                              CARBOGEN AMCIS provides CDMO services for the development and manufacture of HPAPIs (more potent APIs). Their facilities operate to current cGMP practices and can produce material for preclinical testing, clinical trials and commercialization.

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                              Pharma Service: API & Drug Product Development

                              Category: API Development

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                              Eurofins BioPharma Services

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                                ANALYTICAL TESTING FOR HPAPIs

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                                Eurofins BioPharma Product Testing network of laboratories has built new laboratories to handle Category 5 compounds at its Lancaster, PA and Columbia, MO locations.

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                                Pharma Service: Analytical

                                Category: Analytical Testing Services

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                                PCI Pharma Services

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                                ANALYSIS OF CYTOTOXIC & HIGH POTENT APIs

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                                Our facilities also include HEPA filtered air handling systems for the analysis of cytotoxic, teratogenic and uncharacterised products, a darkroom for the analysis of light sensitive products, and have the capabilities to work with Schedule II-IV controlled substances.

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                                Pharma Service: Analytical

                                Category: Analytical Testing Services

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                                Pfanstiehl

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                                DEVELOPMENT & MANUFACTURING OF API & HPAPI

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

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                                Category: API Development

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                                Cambrex Corporation

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                                HIGH POTENCY APIs (HPAPIs)

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                                Cambrex has been reliably developing and manufacturing high potency APIs & compounds for years, including: Immunosuppressants, cytostatics/protein kinase inhibitors, ultra-potent cytotoxic drug substances, drug linkers, drug product intermediates, etc.

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                                Pharma Service: API & Drug Product Development

                                Category: API Development

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                                Globela Pharma

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                                POTENT COMPOUNDS TABLETS

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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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                                Pharma Service: Drug Product Manufacturing

                                Category: Tablet

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                                Bluepharma

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                                HIGH POTENCY PRODUCTS - TABLETS

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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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                                Globela Pharma

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                                POTENT COMPOUNDS CAPSULES

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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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                                Pharma Service: Drug Product Manufacturing

                                Category: Capsule

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                                Bluepharma

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                                HIGH POTENCY PRODUCTS - CAPSULES

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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

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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

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                                DPT Laboratories, Ltd

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                                HIGH POTENCY APIs (HPAPIs)

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                                DPT provides comprehensive pharmaceutical development and research services focused on semi-solid and liquid dosage forms.

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                                Pharma Service: API & Drug Product Development

                                Category: API Development

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                                Stason Pharmaceuticals, Inc.

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                                HIGH POTENCY API TABLETS MANUFACTURING

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                                Stason has capabilities to manufacture high potency APIs tablets.

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                                Category: Tablet

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                                Stason Pharmaceuticals, Inc.

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                                HIGH POTENCY API CAPSULES MANUFACTURING

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                                Stason has capabilities to manufacture high potency APIs capsules.

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                                Category: Capsule

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                                Stason Pharmaceuticals, Inc.

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                                HIGH POTENCY API INJECTABLES MANUFACTURING

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                                Stason has capabilities to manufacture high potency APIs injectables.

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                                Pharma Service: Drug Product Manufacturing

                                Category: Liquid

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                                Servier

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                                HIGH POTENCY APIs (HPAPIs)

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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 & supply chain expertise with full regulatory support.

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                                Pharma Service: API & Drug Product Development

                                Category: API Development

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