The global active pharmaceutical ingredients industry is estimated to be worth $232.13 billion in . By , this figure is expected to reach $328.94 billion at a CAGR of 7.22%. The primary cause for this increase is the growing need for effective therapies, increased chronic disease prevalence, and the development of generic drug manufacturing.
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All pharmacological formulations are built on APIs, which are what give a range of therapies their therapeutic efficacy. To ensure quality and innovation, API pharmaceutical companies are putting smart manufacturing technology into practice and placing a strong emphasis on regulatory compliance.
This blog is all about the leading API manufacturing businesses in the United States, noted for their creativity, regulatory standards, and large-scale production capabilities. We also introduce the top API pharma database company in the United States, which is an invaluable resource for discovering certified suppliers, thorough product catalogs, and manufacturing capabilities.
There is an array of API manufacturing companies in the USA majorly due to their robust research infrastructure and best in class manufacturing facilities.
Here is an in-depth look at some of the top API manufacturers in the USA as of :
Pfizer CentreOne is a global contract development and manufacturing organization. It is a division of Pfizer specializing in API synthesis for complex and large-scale pharma projects.
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With decades of experience in manufacturing small molecule space, Cambrex is a leading U.S. –based CDMO. Cambrex offers end-to-end API development and manufacturing solutions, with numerous manufacturing sites across the country.
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Along with being one of the top API manufacturing companies in USA, Thermo Fisher Scientific also delivers integrated CDMO services through it’s Patheon brand. It has multiple high-capacity manufacturing with the U.S.
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Renowned technically challenging API manufacturing, ranging from energetic chemistry and controlled substances, there’s no doubt that Ampac Fine Chemicals is one of the best API manufacturing companies in USA. Their U.S. plants are equipped for both small and large scale API manufacturing processes.
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The U.S. arm of the Swiss CDMO giant, Lonza offers high-end manufacturing services for both biologic and chemical APIs. The company's U.S. facilities are designed to support innovation at every stage of the drug development lifecycle.
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Siegfried USA, LLC is part of the Swiss-based Siegfried Group, known globally for its high standards in pharmaceutical manufacturing. With its state-of-the-art facility in Pennsville, New Jersey, the company provides robust API manufacturing services tailored to both branded and generic pharmaceuticals.
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Ajinomoto Bio-Pharma Services operates a key US facility in San Diego, focusing on the development and manufacturing of APIs with a specialization in biopharmaceutical applications. Backed by its Japanese parent company, Ajinomoto Co., Inc., it combines innovation with deep expertise in fermentation and synthetic chemistry.
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As one of the largest API pharmaceutical companies based in the United States, AbbVie Inc. combines robust manufacturing capabilities with strong R&D leadership. Its vertically integrated operations ensure quality control across the full API lifecycle.
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Amgen Inc., headquartered in Thousand Oaks, California, is a biotechnology pioneer and one of the leading API manufacturers in USA specializing in biologics. Known for its science-driven innovation, Amgen has built a strong reputation for developing and producing complex biologic APIs.
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Eli Lilly and Company, based in Indianapolis, Indiana, is among the most respected API pharmaceutical manufacturers in the USA, with a legacy of over 145 years in the healthcare industry. Its API operations support a wide range of therapeutic areas including diabetes, oncology, neuroscience, and immunology.
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These companies exemplify the strength and sophistication of the API manufacturing industry in the USA.
Their focus on innovation, compliance, and scalability makes them integral players in the global API pharmaceutical ecosystem. In the following section, we will explore how to identify the most suitable API suppliers using a reliable pharma database.
If you are looking to source the most reliable and comprehensive API manufacturers’ data not only in U.S., but anywhere around the world, just a Google isn’t enough. Procurement, business development, and regulatory professionals need verified, in-depth insights to make informed decisions.
This is where Chemxpert Database adds real value. We are leading API and chemicals database provider that helps you streamline your sourcing process.
Whether you’re managing procurement, assessing regulatory risks, or conducting market research, Chemxpert Database gives you the tools to identify the right partner in the API manufacturing process — faster and with more confidence.
The USA continues to lead in API manufacturing with companies known for quality, innovation, and regulatory compliance. But choosing the right supplier takes more than a quick search.
Chemxpert Database simplifies the process by offering verified data on 250,000+ API products, certifications, DMFs, and more — helping you make confident sourcing decisions faster.
Whether you're in procurement, BD, or regulatory, Chemxpert Database is your go-to tool for finding trusted API manufacturers.
Active Pharmaceutical Ingredients (APIs) are at the heart of any drug formulation. They are the biologically active components responsible for the therapeutic effects of medications. The manufacturing of APIs is a complex and highly regulated process that requires precision, expertise, and adherence to stringent quality standards. This guide aims to provide a comprehensive understanding of API manufacturing, its importance in drug development, and the latest trends and innovations in the field.
APIs play a pivotal role in the pharmaceutical industry. They are essential for the efficacy and safety of drugs. The quality of APIs directly impacts the effectiveness of the final drug product. Therefore, understanding the intricacies of API manufacturing is crucial for pharmaceutical companies aiming to develop safe and effective medications.
APIs can be classified into two main categories: small molecules and biologics. Small molecules are low molecular weight compounds that can easily penetrate cells and interact with biological targets. Biologics, on the other hand, are larger and more complex molecules, such as proteins and antibodies, that are produced using living organisms.
APIs are responsible for the therapeutic effects of drugs. They interact with specific targets in the body to produce the desired pharmacological response. The development of APIs involves extensive research and development to identify and optimize compounds that can effectively treat diseases.
There are 5 key steps in API Manufacturing :
1. Synthesis: The process begins with the synthesis of the API, which involves chemical reactions to create the desired compound.
2. Purification: The synthesized API is then purified to remove any impurities and ensure its quality.
3. Crystallization: The purified API is crystallized to obtain the desired solid form.
4. Drying: The crystallized API is dried to remove any residual solvents.
5. Milling: The dried API is milled to achieve the desired particle size.
Small molecule APIs are typically produced through chemical synthesis. This involves a series of chemical reactions to build the desired compound from starting materials. The process requires precise control of reaction conditions to ensure the quality and yield of the API.
Quality assurance is a critical aspect of API manufacturing. Good Manufacturing Practices (GMP) are a set of guidelines that ensure the quality and safety of pharmaceutical products. GMP covers all aspects of production, from raw material sourcing to final product testing. Adherence to GMP is essential for maintaining the integrity of the API and ensuring its compliance with regulatory standards.
Among the latest trends in API Manufacturing, three major orientations can be identified :
Several Technological Innovations and Advancements can support manufacturing process improvments :
API manufacturing is subject to stringent regulatory requirements. Regulatory agencies, such as the Food Drug Administration (FDA) and European Medicines Agency (EMA), have established guidelines to ensure the quality and safety of APIs. Compliance with these regulations is essential for obtaining market approval for pharmaceutical products.
Regulatory changes can have a significant impact on API manufacturing. Companies must stay updated with the latest regulations and adapt their processes accordingly. Failure to comply with regulatory requirements can result in product recalls, fines, and damage to the company’s reputation.
There are common challenges that can be identified for API Manufacturing :
Strategies can be implemented to overcome the typical challenges of APIs manufacturing :
API manufacturing is a critical aspect of drug development. Understanding the processes, trends, and regulatory requirements involved in API manufacturing can help pharmaceutical companies develop safe and effective medications. By staying updated with the latest innovations and implementing robust quality management systems, companies can overcome the challenges associated with API manufacturing and enhance their drug development efforts.
Contact us to discuss your requirements of API & Intermediate Manufacturer. Our experienced sales team can help you identify the options that best suit your needs.