APIs and Intermediates: The Building Blocks of Modern Pharmaceuticals
Driving innovation at the molecular level for global health
Every life-saving therapy starts with an API, which, together with drug intermediates, forms the core of modern drug development, transforming scientific discoveries into scalable, sustainable, high-purity therapeutic solutions. Alfa Chemistry is a leading supplier of high-quality generic APIs and intermediates to the pharmaceutical industry, accelerating the entire drug development process from discovery to commercialization. Whether you need niche fluorinated APIs, high-potency API manufacturing, or advanced intermediates for complex syntheses, we are your trusted partner from molecule to drug.
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What Is An API?
API refers to the pharmaceutical ingredients used to produce various kinds of preparations and is the active ingredient in the preparations. It is prepared through chemical synthesis, plant extraction or biotechnology to form powder, crystals, extracts and other forms, but the patient cannot take it directly; it generally needs to have excipients added, processing and other steps to be made into a pharmaceutical preparation that can be used directly.
APIs are the basis of drug development and production, and their quality directly affects the quality of the preparation, so countries have developed strict national pharmacopeia standards and quality control methods.
Explore our API portfolioWhat Is A Pharmaceutical Intermediate?
According to the EU REACH regulation, an intermediate is defined as "a substance that is manufactured, consumed or used in a chemical process for the purpose of transforming the substance into another substance." Such substances do not normally appear in the final product, except as impurities. In the chemical industry, "intermediates" usually refer to semi-finished products that are generated during organic synthesis and are intermediate in the production of the final product. For example, in drug synthesis, intermediates are bridges between different chemical reactions and are used for further processing into drugs.
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The Core Difference between APIs and Intermediates
In drug manufacturing, the core difference between an API and an intermediate is their pharmacological activity and end use.
APIs
APIs are active ingredients that have clear pharmacological activity or other direct effects in the diagnosis, treatment, symptomatic relief, control or prevention of disease, or are capable of affecting the function or structure of the human body, and can be used directly in the final clinical formulation.
Pharmaceutical Intermediates
Intermediates are intermediate products in the production of an API that do not have pharmacological activity and can only be used to further synthesize the next product, which is a key pre-process in the production of an API.
APIs and intermediates play different roles in the pharmaceutical industry chain, and together they contribute to the efficient, safe and high-quality production of drugs.
Let's Build the Future of Pharmaceuticals Together - Starting with Molecules
We offer a comprehensive and growing catalog of high-purity APIs and advanced intermediates designed to meet the most demanding specifications of pharmaceutical manufacturers worldwide. Our solutions support every stage of the drug life cycle, from early R&D to large-scale commercialization.
Generic APIs
Fluorinated APIs
Our fluorinated APIs offer superior metabolic stability and bioavailability to meet critical needs in oncology, CNS and anti-infectives.
Explore Product LinesHighly Active Pharmaceutical Ingredients (HPAPI)
Our HPAPI portfolio utilizes specialized process design and analytical validation to support targeted therapies and potent drugs.
Explore Product LinesOther Generic APIs
From cardiovascular to metabolic diseases, our catalog of generic APIs meets global compendial and regulatory standards.
Explore Product LinesAlfa Chemistry offers a wide range of intermediates designed to enable efficient route design for small molecule synthesis, reduce synthesis time and optimize cost - essential for cost-effectiveness and speed to market.
Deuterated Pharmaceutical Intermediates
Enhancing metabolic stability and improving pharmacokinetics for advanced drug discovery programs.
Explore Product LinesFluorinated Pharmaceutical Intermediates
Fluorine-rich structures for backbone modification to improve target binding affinity and membrane permeability.
Explore Product LinesOther Pharmaceutical Intermediates
High purity intermediates for a wide range of therapeutic regimens, with flexible lot sizes and short lead times.
Explore Product LinesPesticide Intermediates
Scalable, customized intermediates for crop protection solutions for the agrochemical industry.
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Pharmaceutical Intermediates
Partnering for Progress
With our global presence, multidisciplinary expertise and relentless pursuit of quality, we are more than just a supplier; we are your strategic partner in pharmaceutical manufacturing.
Call a specialist:
Your Trusted CDMO Partner for High-Value Small Molecule Solutions
Alfa Chemistry specializes in the custom development and scalable manufacturing of APIs and key intermediates. As a leading Contract Development and Manufacturing Organization (CDMO), we provide pharmaceutical innovators with end-to-end solutions—from route exploration and process development to clinical trial supply and full commercial manufacturing.
Our API services cover the entire product lifecycle, from preclinical process development to commercial launch. Whether you require stand-alone API development or a fully integrated service, we can serve you with scientific rigor and operational excellence.
API Process Research and Development
View Details- Design and optimization of synthetic routes for API
- Process development and scale-up from laboratory to industrial scale
- Develop control strategies to regulate starting materials (RSMs), advanced intermediates, and APIs
- Process validation
APIs and Intermediates Manufacturing
View Details- Non-GMP and GMP manufacturing from pre-clinical to commercial for APIs and intermediates
HPAPI Manufacturing
View Details- Process development and production of HPAPI
- Development and validation of analytical methods
Green Chemistry Platform—Sustainable Innovation
We are committed to sustainable pharmaceutical manufacturing, integrating cutting-edge green chemistry strategies into our operations:
Continuous Flow Technology
Enable hazardous reactions to be safer, more scalable and continuous.
Learn More →
Biocatalysis
Enzyme-based transformations with enantioselectivity and low environmental impact.
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Solid State Chemistry
Study polymorphism, crystallinity and salt forms to optimize drug properties.
Learn More →
Why Choose Alfa Chemistry?
Analytical excellence
We utilize state-of-the-art analytical instrumentation and validation programs to ensure consistency, purity, potency and stability at every stage of production.
Manufacturing that meets international standards
Our facilities meet stringent international regulatory standards and are ISO 9001:2015 certified, ensuring global market compatibility and patient safety.
End-to-end support
From route design and process optimization to scale-up and regulatory documentation, our team provides comprehensive support tailored to the complexity of your project.
Sustainable and scalable synthesis
We provide scalable, sustainable and economically viable synthetic routes for APIs and intermediates utilizing green chemistry and continuous process innovation.
Industries We Serve
- Innovative pharmaceutical companies
supporting the synthesis of novel molecules and early clinical supply. - Generic manufacturers
supplying regulatory-compliant APIs and Drug Master Files (DMFs) in key global markets. - CDMOs and CROs
Providing high quality intermediates for clinical development programs. - Veterinary and Health Foods
Providing APIs that meet regulatory requirements across multiple industries.
What Success Stories Can We Share?
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Case 1: Ubrogepant Supplied for Early-Phase Migraine Receptor Binding Research
A neuroscience research team at a pharmaceutical R&D center in the UK sourced ubrogepant from Alfa Chemistry to conduct non-clinical receptor binding assays targeting calcitonin gene-related peptide (CGRP) pathways. The compound was used to benchmark in vitro activity profiles of novel CGRP antagonists under development for migraine therapy. Alfa Chemistry provided non-GMP grade ubrogepant [Catalog Number YM00001] with complete HPLC purity profile (≥99%) and structural data (¹H NMR, MS).
"Using ubrogepant as a reference compound enabled us to validate our assay system. Alfa Chemistry's documentation and consistency made it suitable for scientific benchmarking purposes."
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Case 2: Asciminib Hydrochloride Used in Kinase Selectivity Profiling
A cancer pharmacology lab in Japan procured asciminib hydrochloride [Catalog Number YM2119669713], a BCR-ABL1 allosteric inhibitor, from Alfa Chemistry to evaluate its kinase selectivity against emerging analogs. The compound was integrated into a cell-free enzyme inhibition panel and used in parallel with novel compounds synthesized in-house. The customer received Asciminib hydrochloride with full analytical documentation and non-clinical research-use-only labeling.
"As a validated ABL myristoyl site binder, asciminib hydrochloride served as a critical control in our inhibitor profiling. Alfa Chemistry's reference-grade material supported high-throughput kinase assay development."
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Case 3: Trabectedin Supplied for Mechanistic DNA Repair Pathway Studies
A DNA repair research group at a European cancer research institute purchased trabectedin [Catalog Number YM114899773], a complex marine-derived alkaloid, to study its interaction with nucleotide excision repair (NER) mechanisms in tumor cell lines. Supplied by Alfa Chemistry in microgram quantities for mechanism-of-action investigation only, the compound was analyzed for its DNA-binding kinetics and transcription-coupled repair disruption.
"Due to trabectedin's structural complexity, we needed a reliable source with high purity and documentation. Alfa Chemistry provided analytical clarity and supported our biological mechanistic work without clinical intent."
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Case 4: Nicotinonitrile Intermediate Used in Exploratory Synthesis of Nicotinic Receptor Modulators
A university-based medicinal chemistry group in Canada selected nicotinonitrile [Catalog Number YM100549], an important synthetic intermediate, for the development of novel nicotinic acetylcholine receptor ligands. The compound was utilized in heterocyclic coupling reactions to generate a series of pyridyl analogs. Alfa Chemistry supplied the material with batch-specific CoA, including GC-MS and melting point data, and ensured consistent purity for reaction reproducibility.
"Nicotinonitrile from Alfa Chemistry gave us the synthetic reliability we needed for rapid analog development. Their ability to deliver research-grade intermediates in scale was a key advantage."
*All products are intended for scientific use only and are not intended for human therapeutic, diagnostic, or other pharmaceutical use. You can reach out to us for additional product information or technical support.
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Contact our API and Intermediates team today for customized sourcing, synthesis and scale-up solutions.
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What Our Clients Ask
Do you provide supporting analytics documentation for APIs and intermediates?
Yes, we do. Each product is accompanied by a Certificate of Analysis (CoA), which contains analytical data related to the compound, such as HPLC, NMR, MS and purity profiles.
Can I request a custom synthesis of a pharmaceutical intermediate or a rare API (API)?
Yes, Alfa Chemistry offers custom synthesis and scale-up services, including route exploration and optimization. Please contact us with your specific project needs, molecular structure or desired modifications.
What is your typical lead time for research APIs and intermediates?
Lead times vary depending on the complexity and quantity of the compound. Stock items are typically delivered within 5-10 business days. Custom synthesis or scale-up needs may take 2-6 weeks depending on the synthetic route and quality control requirements.
Can you provide small quantities (milligrams to grams) for screening and feasibility studies?
Yes. We accept study scale requirements at milligram, gram or subgram levels to support early discovery screening, mechanistic studies and synthetic route evaluation.
Can Alfa Chemistry assist with impurity analysis or forced degradation studies on supplied APIs?
Yes. Upon request, we can support custom impurity analysis, forced degradation analysis or stress condition studies to assist in early analytical method development and compound characterization.
Are your intermediates compliant with REACH or other regulatory frameworks?
As our products are used for scientific research only, they are not pre-registered under REACH or other global regulations. However, we do provide Safety Data Sheets (SDS) and handling instructions for responsible use in laboratories.
What storage and stability information do you provide for your products?
We provide recommended storage conditions, stability information (where available), and lot-specific handling precautions for each product. For sensitive compounds (e.g., light/moisture/oxygen sensitive), we may use specific containment or cold chain logistics.
Can Alfa Chemistry support PK/PD modeling of isotope-labeled analogs?
Yes, we do. We offer deuterium- and 13C labeled intermediates or APIs for pharmacokinetic and bioavailability studies and calibration of LC-MS/MS assays, tailored to your internal standard or tracer design needs.
Do you offer solid-state characterization of crystalline APIs or intermediates?
Yes, we do. For projects that require solid-state control, such as crystalline screening or crystal selection in early process studies, we offer optional PXRD (Powder X-ray Diffraction), DSC and TGA services.
Do you offer structure-property support or structure-activity (SAR) consulting during the intermediate design process?
Absolutely. Our chemists can collaborate on structure-activity relationships (SAR), reactivity optimization, or synthetic accessibility assessments to help you select or design intermediates that meet your biological or synthetic goals.
*If you have further questions, please contact our support team who will help you get the most out of Alfa Chemistry's ADCs solutions.
