Small Molecule API CMO Partners
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
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
Cambrex
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
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.
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Curia
Curia is a Contract Development and Manufacturing Organization with over 30 years of experience, an integrated network of 27 global sites, and over 3,500 employees partnering with customers to make treatments broadly accessible to patients. Our biologics and small molecule offering spans discovery through commercialization, with integrated regulatory and analytical capabilities.
Grace Fine Chemical Manufacturing Services
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.
Capabilities
Kymanox Corporation
Kymanox is a life science professional services organization that offers engineering, scientific, and compliance support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With its diverse team, Kymanox helps clients navigate commercialization challenges that arise throughout a product's lifecycle – from early development to post-market commercialization – with optimized safety, quality, efficacy, and accessibility.
Lonza
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
MilliporeSigma
With decades of expertise, we deliver preclinical to commercial success for your small molecule API program through a consultative and phase appropriate approach. With Millipore® CTDMO Services, tap into our global network to seamlessly execute your custom API projects. From conception to commercialization, we tackle the toughest small molecule API synthesis challenges from grams to commercial quantities.
Capabilities
Nanoform
Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners to improve the lives of patients globally by overcoming drug development and delivery challenges through its game-changing nanoforming technologies, novel formulation capabilities and GMP manufacturing facilities. The company's dedicated, multi-disciplinary team has a combined experience of launching 100+ medicines.
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.
SGS
SGS supports clients from discovery to clinical development and commercialization through a comprehensive scope of expert-led QC testing solutions for raw materials, APIs and finished products. Whether you need testing support through every stage of the drug development cycle or just when your in-house capabilities are limited, choose SGS as your trusted partner to support method development and validation, characterization, bioanalysis and final GMP product release.
Capabilities
SK pharmteco
SK pharmteco's mission is to build strong partnerships that deliver life-saving therapies and improve patient outcomes. With seven global facilities, we support the entire product lifecycle, from development to commercial manufacturing, with a collaborative "One Team" approach focused on transparency and trust. Offering CDMO services for small molecules, cell and gene therapy, and analytical testing—connect with our experts today!
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