Small Molecules (API) manufacturing & Development

High-quality active pharmaceutical ingredients (API) via the development of a scalable process that will meet demand at each stage of your product’s life cycle. Complete drug product services from preformulation screening through clinical development to commercial supply. A comprehensive range of oral solid, sterile and softgel dosage forms with expertise in high-potency products. Unique solutions to overcome the toughest solubility challenges and accelerate your path to proof of concept.

Align the development and manufacture of your small molecule API and finished drug product with a world leader in both. In big ways and small, and at every stage, you’ll capture the advantages of fluid collaboration between our sites, teams and operations. You’ll unlock speed, quality and efficiency in ways not possible with any other CDMO.

Small Molecule (API) Technical Capabilities

Ensure that you always have the exact resources and expertise you need, especially for your most difficult to manufacture compounds. With Patheon, a part of Thermo Fisher Scientific, you’ll have access to a vast array of small molecule API capabilities in Europe and the United States. Reactors ranging from 30 L up to 16 m3, comprehensive analytical services and expertise in all the chemistries you expect, as well as many unique solutions and innovative technologies you won’t find anywhere else. It’s a big-picture approach that delivers high-quality API via a seamlessly scalable process that will rapidly achieve your goals at each phase of development while laying a sound foundation for your future success.

  • Microreactor Flow Chemistry: Get the efficiency, flexibility and scalability of the lab of tomorrow made reliable at commercial scale today only from us.
  • Hydrogenation: Leverage this high-yielding, environmentally friendly reduction reaction at any scale with an exceptionally wide selection of process technologies and reaction systems.
  • Advanced Catalysis: Bring feasibility to more of your most challenging discoveries and most complex processes with access to interdisciplinary route scouting, 2,000+ enzymes, proprietary biocatalytic processes and scale-up timelines reduced from years to months.
  • Polymers: Create completely unique products by combining proprietary process technologies, polymer science, advanced synthesis and large-scale cGMP production expertise.
  • Cryogenic Manufacturing: Access low-temperature capabilities down to -85 °C in 200 L – 2,000 L reactors.
  • High-Pressure Manufacturing: Take advantage of 1,000 psi high-pressure processing, including hydrogenation, at 200 L and 2,000 L scales.
  • ß-Lactam: Produce ß-lactam antibiotics at precisely the small scale you require.High-Potency Compounds: Minimize your risks by pursuing highly potent compounds, such as cytotoxics, in facilities featuring the latest safety infrastructure.
  • Controlled Substances: Gain the flexibility of having access to a global network of facilities that are fully licensed by the DEA

Drug Substance

We offer complete API services in Europe and North America. Capabilities that span a vast range of complex chemistries ensuring you’ll have the solution you need. A flexible process that enables rapid scalability for even the most difficult to manufacture discoveries. Quality ensured by comprehensive analytical services. A widely varied portfolio of generic APIs and excipients. An experienced project manager, multidisciplinary team and highly experienced regulatory support.

Product Development

Early development budgets and timelines are exceedingly tight. This pressures companies to do the bare minimum to get to clinical trials. It’s a viable early-stage strategy, but one prone to costly delays if later stages are not also kept in focus. We take a big-picture approach to small molecule product development that employs exceptional efficiency. Stay on budget and rapidly reach key development milestones while laying a scientifically sound foundation for late-clinical and commercial success.

Commercial Product Supply

A fully integrated global network of commercial manufacturing facilities. All with exceptional regulatory track records and pre-approvals from multiple agencies around the world. Capabilities across a comprehensive array of oral solid, sterile and softgel finished dosage forms. Scale-up and tech transfer processes that have won multiple international awards. Capacity at all scales, from small batches of specialized products to international supply of top sellers.

With us, you’ll have a partner with more than 40 years of experience and a reputation for high-quality commercial product supply, built one successful project at a time. Between 2006 and 2015, we helped clients earn 92 overall NDA approvals, that’s nearly twice as many as the next ranked CMO. Last year alone we manufactured more than 700 products approved for more than 70 countries. With us, you’ll have access to all the expertise, technologies and options you’ll need to succeed.

Learn More
Dosage Forms
Process Validation and Tech Transfer
Analytical Services
Commercial Batch Manufacturing
Custom Manufacturing Suites

Portfolio of APIs and Intermediates

High-quality APIs and intermediates made in the same facilities, and to the same stringent standards, as our custom manufacturing projects. These are common building blocks for pharmaceuticals made with an uncommon level of precision. Companies that understand the difference between price and value know pharmaceuticals will only be as good as their chemical components.

Rather than exposing your project to the risks of commoditized materials, source from a reputable partner you know. Whether you need a kilo for an in-house project or barrel after barrel for a commercial project, with us, you can rely upon this portfolio of APIs and intermediates to make your products their best, and simplify your supply chain

  • NeoBr - CAS RN: 114-80-7 - Neostigmine Bromide
  • NeoMS - CAS RN: 51-60-5 - Neostigmine Methylsulfate
  • P1DR - CAS RN: 108-73-6 - Phloroglucinol Anhydrous
  • P1B - CAS RN: 6099-90-7 - Phloroglucinol Dihydrate
  • PyrBr - CAS RN: 101-26-8 - Pyridostigmine Bromide
  • SSD - CAS RN: 22199-08-2 - Silver Sulfadiazine
  • DPCP - CAS RN: 2524-64-3 - Diphenyl-chlorophosphate
  • HPBE - CAS RN: 90315-82-5 - (R)-2-Hydroxy-4-phenylbutanoic acid ethyl ester
  • TMB Milled Flakes - CAS RN: 621-23-8 - 1,3,5-Trimethoxybenzene Milled Flakes
  • CREA - CAS RN: 60-27-5 - Creatinine
  • GF - CAS RN: 5464-28-8/4740-78-7- Glycerolformal—EPT - Glycerolformal—EKT
  • 2-MR - CAS RN: 608-25-3 - 2-Methylresorcinol
  • Moclobemide - CAS RN: 71320-77-9
  • Flucytosine - CAS RN: 2022-85-7
  • Orlistat - CAS RN: 96829-58-2
  • Acitretin - CAS RN: 55079-83-9
  • Colesevelam - CAS RN: 182815-44-7

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