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
Controlled Substances: Gain the flexibility of having access to a global network of facilities that are
fully licensed by the DEA
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.
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.
Process Validation and Tech Transfer
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
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