Dalton Pharma Services
Dalton Pharma Services is a Toronto-based, FDA-inspected and Health Canada-approved cGMP CDMO providing integrated drug discovery, API manufacturing, formulation, and sterile fill/finish services to pharmaceutical and biotechnology clients globally. It is a wholly-owned subsidiary of Japan's Seikagaku Group and operates proprietary robotic aseptic powder fill-finish technology.
- Company typePrivate
- Founded1986
- HeadquartersToronto, Canada
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Dalton Pharma Services does
Dalton Pharma Services is a Toronto, Canada-based Contract Development and Manufacturing Organization (CDMO) that has operated from a single integrated site since its 1986 founding at York University. The company provides pharmaceutical and biotechnology clients with a full lifecycle offering spanning medicinal chemistry, drug discovery, custom chemical synthesis, API process development, cGMP API manufacturing (gram to multi-kilogram scale, reactors up to 300L), formulation development (including liposomes, sterile liquids, and lyophilized forms), cGMP sterile fill/finish, and in-house analytical and microbiological testing under a unified Quality Management System. The platform includes specialized capabilities for controlled substances, oligonucleotides, antibody-drug conjugates, nanoparticles, and cannabinoids.
The company's technical differentiators include the proprietary RoboFil™ robotic isolator-based aseptic powder fill-finish system (developed with 3P innovation and using Fill2Weight technology with ±3% dosing accuracy from 5 mg to 1000 mg), the Capmatic Patriot® automated sterile vial filling line (~40 BPM), a cGMP lyophilizer, and advanced analytical instrumentation including SEC-MALS, ICP-MS (Agilent 7800), and UPLC. Regulatory credentials include FDA inspection, Health Canada approval (Drug Establishment Licence plus three cannabis-related licences), ICH Q3D/Q7/Q1B compliance, Annex 1 alignment, and planned ISO 13485 certification. The business model is project-based contract services with quote-driven pricing, RFP submissions, and direct enterprise business development; complementary product revenue comes from a 2,600+ compound catalog via wholly-owned subsidiary Dalton Research Molecules. Dalton is a privately held subsidiary of Japan's Seikagaku Group, with leadership under CEO Peter Pekos and President Dr. Jixing Wang.
Dalton Pharma Services firmographics
Firmographics- Name
- Dalton Pharma Services
- Legal name
- Dalton Pharma Services
- Website
- https://dalton.com
- Company type
- Private
- Founded year
- 1986
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Dalton Pharma Services is a Toronto-based, FDA-inspected and Health Canada-approved cGMP CDMO providing integrated drug discovery, API manufacturing, formulation, and sterile fill/finish services to pharmaceutical and biotechnology clients globally. It is a wholly-owned subsidiary of Japan's Seikagaku Group and operates proprietary robotic aseptic powder fill-finish technology.
- Ownership category
- akta.pro rank
Dalton Pharma Services industry classification
Industry- Product category
- Pharmaceutical CDMO Services
- NAICS
- Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412), Medicinal and Botanical Manufacturing (325411), Drugs and Druggists' Sundries Merchant Wholesalers (424210)
- SIC
- Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731), Medicinal Chemicals & Botanical Products (2833), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)
- akta.pro primary industry
- Drug Substance–Drug Product Integrated CDMO (HLAGABAG)
- akta.pro secondary industries
- Small-Molecule API & Intermediates CDMO (HLAGABAA), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)
Keywords
Where Dalton Pharma Services is headquartered
LocationHeadquarters
- HQ city
- Toronto
- HQ country
- Canada
- HQ region
- North America
Offices1 record
Markets served
Dalton Pharma Services business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales
Revenue model
- Contract Development and Manufacturing Services (CDMO): Dalton Pharma Services generates revenue by providing integrated pharmaceutical development and manufacturing services on a contract project basis. Services include custom chemical synthesis, cGMP API manufacturing, sterile fill/finish, formulation development, and analytical testing. Revenue is project-based with quotes provided for each engagement. The company does not publicly disclose pricing and operates on a quote-based/procurement model typical of CDMOs.
- Chemical Compounds Catalog (Dalton Research Molecules): A wholly owned subsidiary, Dalton Research Molecules, provides high-quality chemical compounds for research purposes, including building blocks, drugs, metabolites, and controlled substances. The catalog contains over 2,600 compounds and continues to grow.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Project-based contract services — no public pricing tiers; all engagements quoted individually based on project scope. |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels7 records
Dalton Pharma Services product offering
Product offeringCore offering
Dalton Pharma Services is a Contract Development and Manufacturing Organization (CDMO) that delivers integrated drug discovery, pharmaceutical development, and cGMP manufacturing services from a single FDA-inspected, Health Canada-approved facility in Toronto. Services include custom chemical synthesis, API process development, cGMP API manufacturing, formulation development, sterile and aseptic fill-finish (liquid and powder), and contract analytical testing, complemented by a wholly owned chemical compound catalog under Dalton Research Molecules.
Product overview
Dalton Pharma Services is a Contract Development and Manufacturing Organization (CDMO) providing integrated pharmaceutical services from drug discovery through commercial manufacturing. The company operates as a single-site model integrating API development, cGMP manufacturing, formulation, aseptic fill/finish, and in-house QC/microbiological testing. Key services include Drug Discovery & Development Services, cGMP API Manufacturing, cGMP Sterile Filling Services (including Steriles Made Simple℠ program), Custom Chemical Synthesis, API Process Development, Formulation Development (including Liposomal Formulations), Contract Analytical Testing Laboratory, Medicinal Chemistry, Accelerated Stability Testing, Polymorphic Screening, Conjugation Services, and Microbiology Services. The company offers specialized capabilities including GMP Oligonucleotide Fill, Extractables & Leachables Testing, ICP-MS Elemental Analysis, UPLC Analysis, and SEC-MALS Services. Advanced equipment includes the Capmatic Patriot® automated vial filling line and RoboFil™ robotic aseptic powder fill-finish system. A chemical compound catalog (Dalton Research Molecules) with over 2,600 products is available through a subsidiary.
Differentiator
Problem solved
Functional benefit
Brands
- Steriles Made Simple℠: Accelerated clinical sterile vial manufacturing program delivering sterile injectable dosage forms in approximately 4 months
- RoboFil™
Products and services
- Drug Discovery & Development Services Integrated drug discovery and development services featuring synthetic feasibility, scale-up, process development, lead optimization, drug analog synthesis, and structure activity optimization for pharmaceutical and biotechnology clients.
- cGMP API Manufacturing Development and manufacture of complex cGMP Active Pharmaceutical Ingredients from grams to multi-kilograms, supporting preclinical through small-scale commercial manufacturing with reactor sizes up to 300L.
- cGMP Sterile Filling Services Aseptic and terminally sterilized cGMP filling services for clinical through small-scale commercial batches, including liquid injectables and sterile powder filling supported by the RoboFil™ robotic isolator platform and the Capmatic Patriot® automated vial filling line.
- Custom Chemical Synthesis Custom synthesis of low volume, high value small molecules including active pharmaceutical ingredients, pharmaceutical intermediates, drug metabolites, drug analogs, analytical standards, and controlled substances, for biotechnology and pharmaceutical applications.
- API Process Development API process development services including optimization of synthetic routes, identification of GMP-friendly alternative routes, statistical Design of Experiments (DoE) for process parameterization, and documentation of CMC development projects.
- Formulation Development Sterile and non-sterile dosage form development including oral immediate release, sterile liquids, powders, injectables, and lyophilized formulations.
- Contract Analytical Testing Laboratory Comprehensive analytical services including method development and validation, raw material release testing, in-process testing, finished product release testing, and ICH-compliant accelerated, intermediate, and long-term stability testing.
- Medicinal Chemistry Drug discovery and design services including structure-based analog design, synthetic organic chemistry, focused library synthesis, and structure-activity relationship (SAR) elucidation.
- Steriles Made Simple℠ Accelerated Clinical Vial Program Accelerated development program delivering sterile injectable dosage forms into clinic faster using in-stock vial container closure options and commonly used excipients, completing API receipt to clinical batch delivery in approximately 4 months.
- Liposomal Formulations Development Complex liposomal formulation development and manufacturing with small molecules, proteins, and peptides, including both aseptic and terminally sterilized options, supported by more than 10 years of specialized experience.
- GMP Oligonucleotide Aseptic Filling GMP aseptic filling of oligonucleotide drug products using peristaltic filling equipment to minimize hold-up volumes and preserve valuable APIs across clinical batches.
- Dalton Research Molecules Chemical Compound Catalog Catalog of more than 2,600 high-quality chemical compounds for research purposes, including building blocks, drugs and metabolites, heterocycles, natural compounds, labelled compounds, peptides, nucleic acids, organometallics, controlled drugs, and GMP APIs/excipients/adjuvants, sold via the Dalton Research Molecules online catalog.
Quantifiable outcome
- 99.3%+ API purity achieved in multi-kilogram scale-up campaigns for Onco-Innovations' ONC010 drug candidate
- +3 more outcomes
Companies that use Dalton Pharma Services
Customer profileNamed customers6 records
Segments4 records
Ideal customer profiles4 records
Dalton Pharma Services technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Dalton Pharma Services partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core.
- Onco-Innovations LimitedcoreOnco-Innovations partnered with Dalton Pharma Services as its manufacturing partner for its proprietary PNKP inhibitor technology (ONC010), including API process development, intermediate scale-up, and multi-kilogram synthesis campaigns. Work supports IND-enabling studies and Phase 1 clinical readiness. Dalton has conducted expanded synthesis of ~1,560g of precursor A83, a 2kg non-GMP synthesis of A83B4C63, a 952g B4 precursor scale-up, and a 300g API scale-up achieving ~99.3% purity. Manufacturing conducted at Dalton's FDA-registered and Health Canada-approved Toronto facility.
- Vimy Pharmaceuticals Inc.coreDalton Pharma Services supports Vimy Pharmaceuticals, a Toronto-based company developing a made-in-Canada generic version of Semaglutide (Ozempic) for the Canadian market. Dalton provides regulatory-focused formulation development and cGMP manufacturing to support Health Canada approval and 2026 target launch. Featured in BNN Bloomberg interview discussing Canada's pharmaceutical manufacturing capabilities.
- Arch Biopartners Inc.coreArch Biopartners engaged Dalton Pharma Services to complete GMP glass vial filling of cilastatin, the company's drug candidate for preventing acute kidney injury (AKI). Dalton completed the filling stage with quality control over 6-8 weeks. Previously, Dalton provided fill and finish services for Arch's LSALT Peptide (Metablok) which entered the Canadian COVID-19 Trial (CATCO).
- 3P innovationcoreDalton Pharma Services commissioned 3P innovation (Warwick, UK) to design and construct a fully automated state-of-the-art high-speed aseptic powder filling line (RoboFil™). The Robotic Fill-Finish (RFF) Cell from 3P innovation was selected based on feasibility studies of difficult-to-handle powders, increased sterility assurance, and Annex 1 compliance. The multi-year association resulted in a bespoke integrated solution with isolators and linked process chambers.
- TransMedics Group Inc.coreDalton Pharma Services entered a manufacturing agreement with TransMedics to provide powder filling services in the manufacture of the OCS Liver System, which received FDA premarket approval for portable ex-vivo perfusion and assessment of donor organs for transplantation. TransMedics achieved FDA approval for lung, heart, and liver OCS systems, with Dalton supporting commercialization.
- Diamond Therapeutics Inc.coreDalton Pharma Services has an exclusive worldwide partnership with Diamond Therapeutics to provide cGMP psilocybin and other compounds to support clinical trials, research, and future commercial opportunities. Dalton is one of only a few Canadian companies to successfully manufacture cGMP psilocybin for regulatory submissions. Material already produced is sufficient for Diamond's clinical trial needs in the US and Canada.
- Cardiol Therapeutics Inc.coreDalton Pharma Services is the exclusive manufacturer of Cortalex™ THC-free extra-strength (100 mg/mL) oral CBD formulation for Cardiol Therapeutics. Cortalex™ is the first pharmaceutically produced CBD formulated without THC, available exclusively at Medical Cannabis by Shoppers Drug Mart across Canada. Dalton's Health Canada-approved, FDA-registered cGMP facilities ensure consistent composition and THC-free quality.
Scale indicators7 records
Recent moves9 records
Expansion highlights7 records
Dalton Pharma Services competitors and assessment
Company assessmentBroad incumbents
- Thermo Fisher Scientific (Patheon): Through its Patheon CDMO business, Thermo Fisher offers integrated API, oral solid dose, sterile fill-finish, and clinical trial material services; directly overlaps with Dalton's integrated CDMO model but at global scale with commercial manufacturing depth.
- Catalent: Large global CDMO offering comprehensive drug development, biologics, and sterile fill-finish services across dozens of facilities; overlaps with Dalton's aseptic fill-finish and formulation development offerings but operates at much greater scale and breadth.
- PCI Pharma Services: Global CDMO focused on clinical and commercial sterile fill-finish, packaging, and serialization; comparable to Dalton in sterile injectable capabilities but with broader geographic footprint and integrated packaging specialization.
- Recipharm: European-headquartered CDMO offering sterile fill-finish, API manufacturing, and development services; comparable to Dalton's integrated CDMO model though focused more on biologics and with a predominantly European geographic footprint.
- Piramal Pharma Solutions: Global CDMO offering API development, sterile manufacturing, and antibody-drug conjugation services across multiple sites; comparable to Dalton in sterile fill-finish and high-potency API capabilities, particularly in ADC conjugation.
Others
- Lonza: Global CDMO leader offering small-molecule API, biologics manufacturing, and sterile fill-finish; comparable in API manufacturing and aseptic services but at vastly larger scale and with broader modality coverage including cell and gene therapies.
Emerging players
- Vibalogics: Specialty CDMO focused on aseptic fill-finish of live viral vaccines and viral vectors; comparable to Dalton in GMP aseptic fill-finish for advanced modalities though narrower in modality scope and more focused on viral-based therapeutics.
Direct peers
- Hovione: Privately-held mid-sized CDMO specializing in integrated API development, particle engineering, and aseptic fill-finish for small molecules. Comparable to Dalton in integrated single-site model, small-molecule focus, and mid-market positioning serving biotech clients.
- CordenPharma: Global CDMO offering integrated API manufacturing, formulation, and aseptic fill-finish across multiple sites; comparable to Dalton in providing end-to-end contract manufacturing from API to sterile drug product for biotech and pharma clients.
- Alcami Corporation: Mid-sized US-based CDMO providing API development, sterile fill-finish, and analytical services; directly comparable to Dalton in offering integrated contract development and small-batch sterile manufacturing for small and mid-cap pharma/biotech.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Dalton Pharma Services social profiles
Digital presenceDalton Pharma Services compliance and trust
Trust signalCompliance12 records
Dalton Pharma Services financial estimates
Financial estimateRevenue estimate
Valuation estimate
Dalton Pharma Services leadership team
Management profileNumber of profiles
Profiles5 records
Dalton Pharma Services subsidiaries and ownership
Company hierarchySubsidiaries1 record
Dalton Pharma Services funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Dalton Pharma Services M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Dalton Pharma Services
What does Dalton Pharma Services do?
Dalton Pharma Services is a Contract Development and Manufacturing Organization (CDMO) that delivers integrated drug discovery, pharmaceutical development, and cGMP manufacturing services from a single FDA-inspected, Health Canada-approved facility in Toronto. Services include custom chemical synthesis, API process development, cGMP API manufacturing, formulation development, sterile and aseptic fill-finish (liquid and powder), and contract analytical testing, complemented by a wholly owned chemical compound catalog under Dalton Research Molecules.
Is Dalton Pharma Services a public or private company?
Dalton Pharma Services is a private company. It is classified as corporate owned and is currently operating.
When was Dalton Pharma Services founded?
Dalton Pharma Services was founded in 1986. It employs 51 to 100 people.
Where is Dalton Pharma Services based?
Dalton Pharma Services is headquartered in Toronto, Canada, in the North America region.
How does Dalton Pharma Services make money?
Two revenue lines are on record. Contract Development and Manufacturing Services (CDMO) is the primary driver. The others are chemical Compounds Catalog (Dalton Research Molecules).
Who are Dalton Pharma Services's main competitors?
Broad incumbents on record are Thermo Fisher Scientific (Patheon), Catalent, PCI Pharma Services, Recipharm and Piramal Pharma Solutions. Lonza is listed as an others. Vibalogics is listed as an emerging player. Direct peers are Hovione, CordenPharma and Alcami Corporation.
Does Dalton Pharma Services have an API?
No public API is recorded for Dalton Pharma Services.
What industry is Dalton Pharma Services in?
Dalton Pharma Services's product category is Pharmaceutical CDMO Services. Its primary akta.pro industry code is HLAGABAG, Drug Substance–Drug Product Integrated CDMO, with a secondary code of HLAGABAA, Small-Molecule API & Intermediates CDMO. Its NAICS code is 3254 and its SIC code is 2834.