CDMOs offering API Synthesis & Manufacturing (CDMO)
API Synthesis & Manufacturing is an important service area used by sponsors to shortlist partners for specific delivery, regulatory, and execution needs. This page groups CDMO organizations offering API Synthesis & Manufacturing, so you can quickly identify which teams align with your program priorities without having to scan unrelated profiles.
Use this listing as a starting point: open each profile to review scope, facility footprint, and public evidence that supports the listed capabilities. Because the directory is fit-first, the goal is not to crown one universal "best" provider, but to help you build a right-sized shortlist for your stage, geography, and quality expectations.
When you are ready to compare options, move to search and add filters for adjacent criteria such as modalities, indications, and claim status. Combining this service area view with those filters makes it easier to narrow quickly from discovery to outreach while keeping the process transparent and reproducible.
Auto-generated by BioBM Editorial AI.
Matching companies
- ACS Dobfar
Italian CDMO with 50 years of experience offering custom development and manufacturing of active pharmaceutical ingredients, finished dosage forms, and biotech solutions including monoclonal antibodies, with FDA and AIFA approvals.
- ARSI Canada Inc
ARSI Canada is a specialized CRO offering custom synthesis, API scale-up, analytical method development, and drug development services with over 50 years of combined experience and a GMP manufacturing facility in Bangladesh.
- Accela ChemBio
Accela ChemBio designs, synthesizes, and manufactures advanced R&D chemicals and specialty compounds for pharmaceutical and biotech clients.
- Akums Drugs and Pharmaceuticals Ltd.
India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.
- Alfa Chemistry
Alfa Chemistry is a global Contract Research Organization specializing in organic chemistry, material chemistry, and medicinal chemistry, offering custom synthesis, analytical testing, and chemical products for research and development.
- Almac Group
Global CDMO with 7,900+ employees across 18 facilities, offering integrated drug development and manufacturing services including analytical development, formulation, process development, fill-finish, and specialized chemistry capabilities.
- AmbioPharm
FDA-inspected peptide API manufacturer offering GMP custom synthesis, process development, analytical method validation, and vaccine peptide manufacturing from preclinical through commercial scale.
- Amneal Pharmaceuticals
U.S.-based biopharmaceutical company offering oral solid dosage, injectables, and API manufacturing with FDA-approved facilities across the U.S. and India, including advanced capabilities in lyophilization, aseptic processing, and oncology formulations.
- Ardena
Ardena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances.
- Asymchem Laboratories
Asymchem is a CDMO providing integrated API synthesis, drug product development, and biologics manufacturing with specialized capabilities in peptides, oligonucleotides, highly potent compounds, and flow chemistry.
- Aurobindo Pharma CDMO
Aurobindo Pharma Limited is one of the largest generic pharmaceutical companies globally, with a strong commitment to making medicines affordable and accessible.
- Axplora
Global CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.
- BOC Sciences
BOC Sciences is a custom lab chemical supplier offering bulk compounds, custom synthesis, cGMP manufacturing, analytical services, and specialized drug delivery and bioconjugation platforms for pharmaceutical and biotechnology clients.
- BSP Pharmaceuticals
BSP Pharmaceuticals is a CDMO specializing in development and manufacturing of cytotoxic oncology drugs, ADCs, peptides, proteins, and lipid-based formulations from preclinical GLP through commercial supply.
- Bachem
Global leader in peptide and oligonucleotide development and manufacturing, offering GMP-compliant clinical and commercial supply from early research through commercial scale.
- BioVectra
North American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.
- Biocon
Fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.
- CMC Pharmaceuticals, Inc.
CMC Pharma provides integrated formulation development, analytical testing, stability studies, and cGMP manufacturing oversight for small molecule drug programs from preclinical through post-approval, with hands-on regulatory expertise and CMO management built in.
- CRAMSN
CRAMSN is a contract research, development, and manufacturing organization (CRO/CDMO/CMO) offering end-to-end solutions for drug substance and drug product development with GMP-certified facilities recognized by US, EU, Japan, and Canada regulatory authorities.
- Cambrex
CDMO offering drug substance and drug product development, manufacturing, and analytical services across small molecules, peptides, and specialty chemistries.
- Carbogen Amcis
Full-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.
- Catalent
Global CDMO providing end-to-end contract development and manufacturing for pharma, biotech, and consumer health. Delivers 60+ billion doses annually across small molecules, biologics, cell & gene therapies, and clinical supply.
- Charles River Laboratories
Charles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years.
- Clearsynth
Clearsynth delivers advanced deuterium science, isotopically labelled compounds, custom synthesis, and specialized CDMO services for small-molecule drug discovery and development. ISO 17025, ISO 17034, and ISO 9001:2015 certified with capabilities spanning reference standards, generic APIs, process development, and scale-up manufacturing.
- CordenPharma
Full-service CDMO offering cGMP development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, LNPs, oligonucleotides, and oral solid dose across 10 facilities in 6 countries with 3000+ employees.
- Curia
Global CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.
- Dalton Pharma Services
Health Canada–approved and FDA-inspected cGMP contract manufacturer offering integrated drug discovery, development, and manufacturing services including custom synthesis, API production, formulation development, and sterile fill-finish for vials, syringes, and cartridges.
- Dipharma
Global CDMO and API manufacturer with 600 employees, 4 cGMP plants, and 75+ years of experience in hazardous chemical synthesis, offering exclusive synthesis services and catalogue APIs with FDA, AIFA, and PMDA inspections since 1970.
- Divi's Laboratories
World's largest API manufacturer and trusted CDMO partner for 25+ years, offering generic APIs, custom synthesis, peptides, and nutraceutical ingredients to 100+ countries with complete backward integration and green chemistry principles.
- Dr. Reddy's Laboratories
Integrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.
- Fluorochem
Fluorochem supplies over 400,000 high-quality chemicals and reagents globally, with custom synthesis and contract manufacturing capabilities for pharmaceutical and life sciences research.
- Gland Pharma Limited
Gland Pharma is a vertically integrated CDMO offering sterile injectable manufacturing across vials, lyophilized, prefilled syringes, and ophthalmic formats, with four cGMP-compliant formulation facilities and four API manufacturing units, supported by R&D capabilities in formulation, analytical, and process development.
- Global Biotech Laboratories
Global Biotech Laboratories is a peptide and oligonucleotide CDMO offering end-to-end contract development and manufacturing from route scouting through validated commercial supply, with cGMP and ICH Q7 compliance across manufacturing sites on three continents.
- Grand River Aseptic Manufacturing
Sterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.
- Grifols Partnership
CDMO specializing in small molecule injectable products, including concentrated and diluted parenteral formulations and intravenous solutions, leveraging 100+ years of Grifols expertise.
- Lacamas Laboratories Inc.
Large-scale contract manufacturer of pharmaceutical intermediates and fine chemicals with over 32,000 gallons of reactor capability, specializing in process development, scale-up, and hazardous chemistry handling.
- Laurus Labs
Global pharmaceutical company specializing in APIs, formulations, and CDMO services for small molecule and biologics.
- Lonza Cell & Gene Technologies
Lonza is the world's leading CDMO, founded in Switzerland in 1897, serving the healthcare industry with integrated offerings for contract development and manufacturing of therapies across multiple modalities.
- Micromacinazione
Swiss-based CDMO specializing in particle engineering and micronization with over 50 years of experience. Offers micronization, milling, spray drying, solid-state characterization, and complementary processing services (classification, blending, cryogenic, co-micronization, conditioning) for APIs, HPAPIs, controlled substances, and excipients from early development to commercial GMP scale.
- Neuland Laboratories
Global API CDMO supporting biotechnology and pharmaceutical companies in design, development, and manufacturing of complex active pharmaceutical ingredients from early-stage drug development through commercial scale.
- PHT International, Inc.
PHT International is a Contract Research, Development, and Manufacturing Organization (CRDMO) offering small-molecule process R&D, cGMP manufacturing from milligrams to multi-tons, and chemical sourcing with global facilities across North America, Europe, and Asia.
- Patheon (Thermo Fisher Pharma Services)
Patheon is a trusted global contract development and manufacturing organization (CDMO) partner owned by Thermo Fisher Scientific, offering 360° integrated solutions from early-stage R&D through clinical supply and commercial manufacturing.
- PharmaBlock
Leading provider of innovative chemistry products and services for pharmaceutical R&D and commercial manufacturing, with expertise in process development, GMP manufacturing, and low-carbon chemistry solutions.
- Pharmaron
Premier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.
- Piramal Pharma Solutions
CDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management.
- PolyPeptide Group
Specialized global CDMO for peptide-based active pharmaceutical ingredients, supporting development and manufacturing of proprietary and generic APIs with expertise in peptide synthesis and GMP manufacturing.
- Quotient Sciences
Integrated CDMO offering drug product formulation and manufacturing for small molecules and synthetic peptides, with 30+ years of experience and scalable capacity from clinical to 500 kg commercial batches across US and UK facilities.
- Roquette Pharma Solutions
Roquette is a leading global provider of plant-based ingredients, excipients, and solutions for the pharmaceutical and healthcare industries.
- SEQENS
Global CDMO and specialty ingredients manufacturer with 16 production sites and 9 R&D centres offering custom development and GMP manufacturing of pharmaceutical APIs, intermediates, and specialty chemicals from preclinical to commercial scale.
- SK pharmteco
SK pharmteco is a CDMO offering comprehensive drug development and manufacturing services.
Markdown mirror: /services/svc_api_synthesis.md