Expertise and technology to
guide you from concept to cure

Curia offers scalable science and personalized expertise with end-to-end API research and development capabilities.

Rely on our best-in-class CDMO offering

Solutions Regulatory

The power of a partnership with Curia from discovery to commercial manufacturing

Extensive catalog

Access to a robust portfolio of more than 240 generic and commercial APIs

Global network

12+ GMP facilities in the US, Germany, France, Spain, Italy, UK and India

Regulator inspected

Facilities successfully inspected by the FDA, KFDA, PMDA, ANVISA, MHRA and AIFA

SafeBridge® certified

Industry leader in safe handling of potent APIs

Controlled substance capable

DEA registrations for research, manufacturing, and export of Schedule I-V controlled substances

Flexible scale

cGMP manufacturing at scales from 10L -2000L into vials or syringes

Solutions

Accelerate your product to market

Our small molecule discovery and clinical scale network

Hyderabad (India)

Major technologies & families

  • Chemical development
  • Analytical services
  • Discovery
  • Medicinal chemistry
  • Separations and analytical method development
  • Custom libraries

Activity

  • Discovery
  • Process R&D
  • Analytical

León & San Cristóbal (Spain)

Major technologies & families

  • Fermentation
  • Downstream PD
  • Cell banks
  • Strain improvement
  • Centrifugation
  • Filtration
  • Chromatography
  • Crystallization

Activity

  • Process development
  • Scale up

Albany, West (US, NY)

Major technologies & families

  • Synthetic PD
  • Fermentation
  • Biotransformation
  • Potent compounds

Activity

  • Process development
  • Scale up

Buffalo (US, NY)

Major technologies & families

  • Medicinal chemistry
  • Computer-aided drug design
  • DMPK
  • Biology
  • Label-free screening
  • Vector discovery, engineering and development
  • Advanced therapeutics
  • Plasmids
  • mRNA
  • Cell engineering

Activity

  • Discovery

Albany, East (US, NY)

Major technologies & families

  • Medicinal chemistry
  • Computer-aided drug design

Activity

  • Discovery

Chemical process development network

Chemical process development

Rely on our chemical process development network of 150+ scientists, global facilities, and the latest technologies

  • Efficient route scouting, rapid process development, and optimization of reaction conditions
  • Scalable manufacturing processes from preclinical to GMP manufacturing
  • For both high-potency APIs and DEA-licensed controlled substances
Fermentation

Dedicated manufacturing facilities and a strong portfolio of steroids and hormones.

Drug substance and drug product formulation development

Comprehensive services and 30+ years of experience

Helping you identify risks and manage the complexities of bringing molecules to market

Analytical method development and material release services

Reliable regulatory, chemistry and advanced instrumentation expertise to support your analytical method development.

A skilled team working under cGMP to deliver consultative reports and protocols.

Separation science

We deliver separation services across the drug development continuum.

  • Classic and chromatographic techniques for the isolation of controlled substances and potent compounds
  • Purification and chiral resolutions for APIs and intermediates – from gram to kilogram scale

We are a trusted global partner for the API commercial supply

Catalog offering

API & Intermediates Catalog ›
Fine Chemicals Catalog ›

Fermentation services

Combined state-of-the-art facilities and process teams with clinical to commercial scale manufacturing

Backward-integrated to fermentation for certain steroidal and hormonal intermediates

High-potency manufacturing services

Whether you need grams or kilograms per year, our team offers expertise in the production, handling and containment of cytotoxic and highly potent compounds.

API manufacturing from clinical scale to commercial scale

Broad range of complex APIs – from generics and potent and cytotoxic compounds, to sterile APIs, steroids and controlled substances.

Small-scale manufacturing ›

Small-scale manufacturing integrating process development, analytical development, clinical-scale API manufacturing, drug product manufacturing, and sterile fill-finish services.

Commercial production ›

Commercial production network delivers global, world-class facilities and a portfolio of generic and commercial APIs.

Complete suite of sterile fill-finish services

Integrating your drug product manufacturing needs at any scale and for all sterile dosage forms.

Spotlight on on Frankfurt & Grafton
Part of our biologics discovery and clinical scale network

Frankfurt (Germany)

Typical quantities

  • 100 g to 1,000 kg

Major technologies & families

  • Multi-purpose
  • Cryogenic
  • Hydrogenation
  • Distillation
  • Enzymes

Activity

  • Fast production
  • Commercial production

Pilot plant type

  • Pilot plant

Grafton (US, WI)

Typical quantities

  • 100 g to 1,000 kg

Major technologies & families

  • Prostaglandins
  • Potent compounds
  • Controlled substances

Activity

  • Scale up
  • Commercial production

Pilot plant type

  • cGMP pilot plant

Regulatory

Clear your path from concept to candidate

Proven track record

257

Commercial products

1,000+

Proprietary DMFs across global markets

100+

Regulatory inspections pass in the last 5 years

Proven track record in regulatory support

Our track record for quality is proven with thorough compliance with the FDA, EMA, PMDA and other regulatory agencies and more than 550 API dossiers filed worldwide.

  • Global filing support
  • CMC module authoring (drug substance and drug product)
  • Certificate of Suitability (CEP) authoring and maintenance
  • Pre-IND and pre-NDA/ANDA meetings, Type C meetings, etc.
  • Consulting and deficiency management
  • Site registrations, U.S. Agent services
  • Publishing services (eCTD)
  • DEA registrations
  • DEA consulting
  • Quota requests
  • Determination requests
  • Researcher protocols

API manufacturing journeyWhatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.

Diverse program experienceDiverse program experience across emerging and established modalities, such as mAbs and mRNA, demanding specialized and complex regulatory support.

Integrated teams between small moleculeIntegrated teams between small molecule and biologics leveraging each other’s expertise and global regulatory authority relationships.

Resources

View All Curia Resources Media
Essentials of an Industry-Leading CDMO Partner for Highly Potent Projects
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High Potency API Maintaining Best Practices Through Continuous Improvement and Lessons Learned
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Biologics Discovery Development & Manufacturing
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The benefits of end-to-end formulation and fill-finish of biologics
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The Shift Toward US Pharmaceutical Manufacturing: Considerations in Attaining the Right Global Mix
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Curia Leads the Industry in Highest Ranking from SafeBridge for Highly Potent Compound Safety
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Curia Completes Acquisition of LakePharma
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Tri-Institutional Therapeutics Discovery Institute and LakePharma (now part of Curia): A Partnership in Antibody Discovery to Enable Innovative Therapeutics
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Curia to Acquire Integrity Bio, Expanding Biologic Formulation and Fill-Finish Capabilities
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Curia Enters Cooperative Agreement with U.S. Government to Expand Sterile Fill-Finish Capability
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Curia is a Contract Development and Manufacturing Organization with over 30 years of experience, an integrated network of 29 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. Our scientific and process experts and state-of-the-art facilities deliver best-in-class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate and sustain life-changing therapeutics.