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
Albemarle
Albemarle FCS is a reliable US 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 US facilities.
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Almac Group
The Almac Group is a CDMO that provides services ranging from R&D, biomarker discovery, API manufacture, formulation and analytical development, clinical trial supply, IRT technology through to product launch, commercial drug product manufacture and packaging.
Asymchem
Asymchem is a leading global contract development and manufacturing organization focused on developing practical and sustainable processes for both clinical phase and commercial scale projects in pharmaceutical & biopharmaceutical industries, with the inspections of NMPA, USFDA and other global regulatory authorities. State-of-the-art facilities and strong expertise in advanced technologies, such as continuous flow, biotransformation, beta-lactam containment and the development and manufacturing of peptides and potent API.
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.
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.
Capabilities
CordenPharma International
CordenPharma is your full-service partner in Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under four technology platforms – Peptides, Lipids & Carbohydrates – Injectables - Highly Potent & Oncology - Small Molecules - CordenPharma experts translate complex ideas, processes and projects at any stage of development into high-value products.
Capabilities
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.
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.
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
Recro Gainesville
Recro Gainesville provides oral solid dosage form development, regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in modified release oral solid dose and DEA controlled substances, Recro has the experts to deliver our clients’ most complex pharmaceutical development and manufacturing projects in our best-in-class facilities, totaling 120,000 square feet.
Capabilities