FOUNDING & SUSTAINING MEMBERS
Afton Scientific operates a state-of-the-art cGMP manufacturing facility in Charlottesville, VA that offers Grade A/Class 100 processing fully compliant with FDA and EMEA regulations. The Grade A/Class 100 clean room is suitable for liquid fills of 1-100-mL per vial, with production sizes from 100 to 15,000 units. The facility also provides pre-sterilized and packaged components such as sterile vials for customers looking to perform their own aseptic fills. All relevant equipment is fully validated according to cGMP requirements and the facility is both MHRA and FDA inspected. Afton offers these services to both multinational pharmaceutical companies as well as emerging biotechs in North America, Europe, Asia, Australia, and Africa.
BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face. Experience makes the difference: with over 80 years of parenteral expertise, we can help to navigate the pathway of success for your molecule. BioPharma Solutions provides our clients with confidence of delivery, service, and integrity – we know the work we do is ultimately vital to the patients you serve. BioPharma Solutions offers resources to help solve the high-stakes challenges you face in today’s complex parenteral marketplace.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, NJ.
Coldstream Laboratories is your partner to develop and manufacture parenteral drug products in liquid and lyophilized dosage forms. Unique mobile isolator technology within our FDA-approved sterile manufacturing facility ensures product containment for highly potent compounds. Our skilled staff supports all aspects of the drug development process, including analytical chemistry and pre-formulation/ formulation development services. Our onsite microbiology lab offers both method validation and routine micro testing services.
Centrally located in Bloomington, IN, Cook Pharmica is a privately held contract development and manufacturing organization (CDMO) that provides pharmaceutical and biopharmaceutical companies with a unique one-source, one-location model for development, clinical and commercial cell culture manufacturing, formulations, parenteral product manufacturing (liquid vial, lyo vial, pre-filled syringe) and secondary packaging. Driven by dedication to its customers and their patients, Cook Pharmica maintains a simple goal: deliver quality products in a timely manner. To do this effectively, Cook Pharmica has invested heavily in its facility, people and processes.
Halo Pharmaceutical is a CDMO that provides scientific, regulatory, manufacturing services and development expertise to help customers bring their products to market quickly, effectively and on budget.
Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer, able to manufacture sterile injectable, solid and semi-solid dosage forms. Our facilities across North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full-range of support and services to streamline the manufacturing process, such as on-site assistance from process qualifications and regulatory submittals through product release.
Metrics, Inc. (Greenville, NC) is a full-service global CDMO specializing in oral dosage forms. A subsidiary of Mayne Pharma USA, Metrics offers clients comprehensive analytical and formulation development from first-time-in-man (FTIM) through Phase I, II, III CTM manufacturing and commercial launch. Unique capabilities include potent and cytotoxic compound controls (OEL 3A and 3B), controlled substances, bioavailability enhancement and modified release.
Patheon is a leading provider of CDMO services to the global pharmaceutical industry for a full array of solid and sterile dosage forms. Patheon, a DPx Holdings B.V. business unit, encompasses the combined CMO capabilities and pharmaceutical product development services (PDS), as well as the Biosolutions and Biologics (BIO) business.
Pfizer CentreOne is multi-specialty contract manufacturer that has been developing, manufacturing and commercializing APIs and drug products for more than 40 years. Our areas of focus are API synthesis and sterile injectables fill-finish. As a global CMO embedded within Pfizer, we have a dedicated team of experts who are devoted to you and your compound, backed by the quality and resources of Pfizer. Drug manufacturing is a complex journey filled with risk. Let us be your guide.
Therapure is an integrated CDMO that provides services for complex proteins expressed from various sources such as mammalian cells, transgenic and plasma. In addition, we provide aseptic fill/finish services for both biologics and small molecules. Our people have the scientific and technical expertise to successfully deliver at every stage of product development and commercial manufacturing of your therapeutic with passion, responsiveness and commitment to improve patient care.
With more than 50 years of global pharmaceutical development and manufacturing services experience, 3M is proud to provide customers with proven inhalation, transdermal, oral and topical manufacturing expertise, while ensuring the highest standards of manufactured product delivery from feasibility to market.
WellSpring provides full-service pharmaceutical contract manufacturing and packaging services for virtually all solid and semisolid dosage form products including tablets, capsules, creams, lotions, ointments, gels and non-sterile liquids. Our facility is cGMP compliant and has been successfully inspected by Health Canada and the U.S. Food and Drug Administration. By emphasizing control over all aspects of our operations, our clients can be assured that products will meet their most rigid specifications.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form Alcami, a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services.
Althea is a fully integrated, contract development and manufacturing organization providing a broad range of clinical and commercial scale services. Althea offers cGMP drug product aseptic vial and syringe filling and drug substance manufacturing of microbial-derived recombinant proteins and plasmid DNA. A comprehensive range of development services are available including: upstream/downstream process development, analytical development, complex formulation, product release, ICH-compliant stability testing. Althea’s drug delivery formulation platform, Crystalomics® technology, delivers high concentration and sustained release formulations of large molecule biologic API. For more information visit us at www.altheaCMO.com
CMIC CMO USA (“CCU”) is a part of the CMIC Holdings group, a pioneer and leading CRO company in Japan providing comprehensive support services to pharmaceutical companies throughout their whole value chain, including development, manufacturing, sales and marketing: a pharmaceutical value creator. For over 10 years, CCU has provided fully integrated contract development, manufacturing, and analytical testing solutions of oral solid dosage forms, from early drug development through clinical and commercial manufacturing. With strong expertise in all fluid bed technologies, CCU can provide solutions to even the most challenging solid dose formulations. Together with the seamless collaboration with our CDMO division in Japan and Korea, CCU is uniquely positioned to serve as the pharmaceutical industry’s preferred strategic partner.
Coating Place is the leader in Wurster fluid bed formulation development and manufacturing. CPI provides a complete range of services from bead layering, extrusion / spheronization, and roller compaction to capsule filling and tableting. We process both solvent and aqueous formulations. Facilities are DEA licensed and FDA registered.
DPT and Confab are leading contract development and manufacturing organizations (CDMO) offering extensive sterile and non-sterile services for solid, semi-solid and liquid dosage forms. We have aligned our businesses to leverage the expertise and strengths from both DPT and Confab. Our scientific teams provide a solutions-oriented approach that drives research excellence. With an exemplary regulatory compliance record, cGMP-compliant facilities and specialists in technical transfers and scale-up, we are your premier pharmaceutical development and manufacturing partner.
Ei LLC specializes in formulating, developing and manufacturing topical Pharmaceutical and OTC semi-solids, liquids, and powders. From de novo formulation, development, and analytical work including physical characterization, method development and validation, through clinical supply manufacturing and full commercial scale up, Ei works with our customers to quickly advance their topical projects. Ei can provide clinical supplies or commercial runs in all package types and sizes including unit dose, sample sizes, and trade sizes in bottles, jars, pumps, vacuum filled airless pumps, packettes, and even dual-chamber components. Ei focuses on providing perfect product reliably to help customers protect and grow their brand.
Groupe PARIMA is an integrated Contract Development and Manufacturing Organization (CDMO) specialized in the development and manufacturing of non-sterile liquid, suspension, semi-solid and spray drug products. We have over 20 years expertise in supporting the full life-cycle of drug products, from initial formulation development to manufacturing of clinical lots and then full commercial scale manufacturing. With presence in 27 countries, we operate on a global scale. In our US-FDA and Health Canada inspected facility, we currently develop and manufacture drug products (prescription and OTC) for the US and Canadian markets, in addition to the European, Asian, Latin and South American markets. We can serve as your gateway to overseas markets.
IDT Biologika is an innovative privately-held company with more than 90 years of experience in research, development, manufacture and distribution of biologics for the global protection of human and animal health. With the expertise and capacity to handle large-scale campaign production of human vaccines and biopharmaceuticals, IDT Biologika brings development, testing and regulatory excellence along with state-of-the-art manufacturing lines required to advance projects with the highest level of quality, efficiency and consistency of supply.
LSNE Contract Manufacturing is a privately held company with three manufacturing facilities located in New England. LSNE has been providing cGMP services to the pharmaceutical, biotechnology and medical device industries since 1997; specializing in a wide range of services including process development, fill/finish and lyophilization. LSNE offers both the flexible approach commonly required with preclinical projects, as well as the cGMP framework necessary for late stage clinical and commercial manufacturing. Through the thoughtful integration of three processing facilities, qualified staffing and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted material for clinical through commercial.
For over 65 years, Mission Pharmacal has remained true to the commitment of its founder, H.N. Walsdorf, to provide the highest quality healthcare medications and treatments available to its loyal consumers. Privately held, Mission has headquarters and manufacturing facilities in San Antonio, TX. The company also has R&D facilities in Texas, as well as a commercial office in the Northeast corridor, the hub of the pharmaceutical industry. Now a third-generation company, Mission Pharmacal manufactures a wide range of prescription medications and over-the-counter products in four expanding therapeutic areas of focus: women’s health, urology, pediatric, and dermatology. The company’s focus starts with the selection of superior raw materials, continues through state-of-the-art manufacturing facilities, and finishes with product packaging that reflects its emphasis on patient well-being. Mission Pharmacal have an established expertise in solid dose tablet manufacturing that has earned international acclaim.
In June 2015, Mission Pharmacal acquired ProSolus Pharmaceuticals, a transdermal research, development, and manufacturing company. ProSolus is focused on formulating and developing high-barrier-to-entry Transdermal Drug Delivery systems (TDDs) for ANDA, NDA, and 505(b)(2) applications. Its state-of-the art pharma facility in Miami, FL is managed by a seasoned leadership team with more than 65 years of experience. With the newly completed manufacturing wing and 50 million+ transdermal patch capacity, ProSolus effectively and efficiently delivers results from the conceptual formulation stage, through the clinical stage, to the coating stage completing the cycle and preparing the product for packaging.