Small Molecule API CMO Sourcing Center
The FDA defines Active Pharmaceutical Ingredient (API) as any substance or mixture of substances intended to be used as the active ingredient in the manufacture of a drug or medicinal product.
Your API may need to be in the form of liquids, powders, crystals and extracts, and processed by chemical synthesis, plant extraction, or other means. The synthesis of small-molecule APIs, although successfully performed for decades, still presents a complicated, multi-step process involving chemical transformations and operations on a range of raw materials with different physical and chemical properties. Specialized expertise is needed to achieve success, from small-scale development, to cGMP clinical and commercial quantities.
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Small Molecule API CMOs
AbbVie Contract Manufacturing
AbbVie manufactures a wide range of compendia-grade active pharmaceutical ingredients (APIs).
Capabilities
Ajinomoto Bio-Pharma Services
Working with Ajinomoto Bio-Pharma Services, you get a trusted CDMO partner that has the power to make your every challenge our own, sharing your unwavering tenacity and dedication from pre-clinical program to commercial successes. We leverage our broad range of capabilities and services at our sites in Belgium, India, Japan, and the US to support your program goals.
Capabilities
Bora Pharmaceuticals
Specializing in complex modified release and solvent processing, Bora CDMO is devoted to exceptional quality standards and flexible delivery of its partners’ projects.
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Catalent
Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products.
Celanese
Celanese Corporation is a global chemical leader in the production of differentiated chemistry solutions and specialty materials used in most major industries and consumer applications. Our businesses use the full breadth of Celanese's global chemistry, technology and commercial expertise to create value for our customers, employees, shareholders and the corporation.
Capabilities
Evonik
Evonik serves as a global development partner and solutions provider to biotechnology companies to help them transform complexity into value. We bring together a broad, versatile range of core competencies, a trusted global network of sites, and strong technical expertise to support you in the development, scale-up, and manufacturing of biopharmaceutical products.
FAREVA
FAREVA’s Drug Substance Manufacturing performs cGMP manufacturing of small molecule APIs from 1 kg to 250 MT. FAREVA API manufacturing has three locations (FAREVA - Excella, FAREVA – Valdepharm, FAREVA – La Vallée) supporting drug substance manufacturing for both clinical trials and commercial production.
Grace Fine Chemical Manufacturing Services (FCMS)
Grace FCMS is a reliable U.S. domestic supplier of RSMs, intermediates and high-value APIs. For more than 40 years, our long-tenured teams have supported customers across the full breadth of their small molecule drug substance programs, successfully scaling up many compounds from our integrated U.S. facilities.
Kindeva Drug Delivery
Headquartered outside St. Paul, Minnesota, Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microstructured transdermal systems (microsystems), and connected drug delivery.
Lonza Pharma & Biotech
Lonza is one of the world’s most renowned companies for contract development and manufacturing, Lonza Pharma & Biotech is recognized for our reliable, high-quality services, our global capacity, our innovative technology platforms, and our extensive experience.
Nanoform
Nanoform works together with pharma and biotech partners globally to reduce attrition in clinical trials and enhance their molecules’ formulation performance through its nanoforming™ services. The Company’s patented and scalable Controlled Expansion of Supercritical Solutions (CESS®) technology produces nanoformed API particles as small as 10nm. This enables poorly soluble molecules in the pharmaceutical pipeline to progress into clinical development by increasing their rate of dissolution and by improving their bioavailability.
Capabilities
Patheon, by Thermo Fisher Scientific
Thermo Fisher Scientific’s Patheon provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes.
PCI Pharma Services
PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.
Capabilities
Pfizer CentreOne
Pfizer CentreOne is a global CDMO embedded within Pfizer and a leading supplier of specialty APIs.
Working together with our customers, we combine our knowledge with open dialogue to solve challenges.
Pharmaceutics International
Pharmaceutics International, Inc. (Pii) is a premier Contract Development and Manufacturing Organization (CDMO), offering unparalleled scientific insight and depth of product knowledge, while supplying high quality dosage forms that enhance the lives of patients worldwide.
Capabilities
Syngene International
Syngene provides comprehensive process R&D services as well as cGMP manufacturing capacities to help clients with investigational to commercial-scale development programs. We cater to several industries including pharmaceuticals, specialty chemicals, agrochemicals, polymers, oligonucleotides, animal health, and consumer products. We provide end-to-end, integrated services ranging from process design and development to large-scale manufacturing for conventional small molecules, highly potent molecules and macromolecules.
Capabilities
Uquifa Inc
With 80 years of experience, UQUIFA’S business model is based on a combination of a quality manufacturing platform and a track record of service and reliability. UQUIFA is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates for the pharmaceutical and animal health industries globally. The Company has four manufacturing sites with strict adherence to all regulatory norms.
Capabilities