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
Abbvie
AbbVie Contract Manufacturing partners with companies across the globe to develop, scale and manufacture pharmaceutical products and bring them successfully to market. Drawing on more than four decades of success as the manufacturing division of AbbVie, we have the depth of experience and the technical knowledge to navigate issues and deliver the innovative solutions customers need. We are much more than a CMO – we are your partner for success.
Capabilities
Asymchem
Asymchem is a leading global CDMO established in 1995 in North Carolina, U.S., dedicated to delivering integrated, end-to-end solutions across the pharmaceutical value chain. Operating from a global network of R&D and manufacturing facilities in China, the U.S and UK, Asymchem employs more than 9,000 professionals worldwide, with 45% of those dedicated to R&D.
Capabilities
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’s Fine Chemical Manufacturing Services (FCMS) is a North American contract development and manufacturing organization (CDMO) with decades of experience partnering with biotechs and pharma companies to solve complex chemistry challenges and seamlessly scale your small molecule project, from early development through commercial manufacturing and every phase in between. We offer development and manufacturing support for RSMs, intermediates, peptide building blocks, and custom active pharmaceutical ingredients (APIs) at our integrated U.S.-based facilities.
Capabilities
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.
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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.
Pharma Expanse
Pharma Expanse is a leading provider of contract development and manufacturing services, supporting manufacturing of RSMs, APIs, Drug Product, and Cell Therapies. Pharma Expanse has drug product capabilities across a number of modalities including small molecules, biologics, ADCs, peptides, and nucleic acids (mRNA). Cell Therapy capabilities include cell line development, master cell banking, and GMP manufacturing of allogeneic induced Pluripotent Stem Cells (iPSCs) for oncology and regenerative medicine.
The Pharma Expanse network currently spans across 20 manufacturing sites in 8 countries and can support discovery, preclinical, clinical, and commercial programs for New Chemical Entities (NCEs).
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!
Capabilities
X-Chem
X-Chem is redefining small molecule drug discovery through a powerful combination of computational sciences, discovery chemistry and data-driven insight. As the pioneer and global leader in DNA-encoded library (DEL) technology, X-Chem provides the foundation for smarter hit identification, accelerated lead progression and greater confidence in early discovery.
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