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
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.
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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
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.
GVK Biosciences
GVK BIO is a global Contract Research & Development Organization (CRDO) providing Drug Discovery and Development services to the biopharma industry.
Capabilities
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.
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