Leading API Manufacturing Companies in the USA

  • Admin
  • Active Pharmaceutical Ingredient
  • 19 May 2025

The global active pharmaceutical ingredients industry is estimated to be worth $232.13 billion in 2025. By 2030, 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.

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.

Top 10 API Manufacturing Companies in USA

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 2025:

1. Pfizer CentreOne

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.

Key Capabilities:

  • High-potency API (HPAPI) production
  • Custom synthesis and scale-up services
  • Development and commercialization of complex compounds

Certifications & Regulatory Strength:

  • FDA and EMA approved
  • Operates under strict cGMP compliance
  • Recognized for strong regulatory inspections and quality assurance systems

Global Reach:

  • Supplies APIs to global pharmaceutical leaders
  • Integrated into Pfizer's worldwide distribution network

2. Cambrex Corporation

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.

Key Capabilities:

  • API manufacturing for both branded and generic drugs
  • Process development, scale-up, and commercial production
  • Expertise in highly potent APIs and controlled substances

Certifications & Regulatory Strength:

  • cGMP compliant
  • Audited regularly by the FDA and other international authorities
  • DEA-licensed for controlled substance production

Global Reach:

  • Strong presence in North America and Europe
  • Exports APIs to over 100 countries

3. Thermo Fisher Scientific (Patheon)

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.

Key Capabilities:

  • Small and large molecule API manufacturing
  • Flexible batch sizes from pilot to commercial scale
  • Advanced technology platforms for biologics

Certifications & Regulatory Strength:

  • FDA, EMA, and PMDA compliant facilities
  • Robust quality systems and analytical capabilities

Global Reach:

  • Supplies APIs and intermediates globally
  • Partners with biotech startups and top-tier pharma companies

4. Ampac Fine Chemicals

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.

Key Capabilities:

  • Specialization in energetic and hazardous chemistry
  • Controlled substance API production
  • Custom synthesis services

Certifications & Regulatory Strength:

  • DEA registered and FDA approved
  • Strong history of regulatory compliance

Global Reach:

  • Supplies to both domestic and international pharmaceutical companies

5. Lonza (USA Division)

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.

Key Capabilities:

  • High-potency APIs (HPAPIs)
  • Biologics and antibody-drug conjugate (ADC) production
  • Advanced process development and analytical services

Certifications & Regulatory Strength:

  • Fully compliant with FDA and global cGMP standards
  • Experienced in regulatory submissions for both NDA and ANDA products

Global Reach:

  • Lonza serves clients in over 120 countries
  • Integrated global supply chain and logistics support

6. Siegfried USA, LLC

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.

Key Capabilities:

  • API and intermediate manufacturing
  • Process development and validation
  • Focus on customer-specific solutions

Certifications & Regulatory Strength:

  • FDA and EMA approved
  • Operates under global quality and safety standards

Global Reach:

  • Supplies APIs and intermediates to global markets
  • Known for reliability and on-time delivery

7. Ajinomoto Bio-Pharma Services (San Diego)

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.

Key Capabilities:

  • Small- and large-scale synthesis
  • High-purity API production
  • Specialized in peptides, oligonucleotides, and biologics

Certifications & Regulatory Strength:

  • FDA and EMA approved
  • Known for environmental sustainability and safety compliance

Global Reach:

  • Serves clients across North America, Europe, and Asia
  • Strong in contract manufacturing partnerships

8. AbbVie Inc.

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.

Key Capabilities:

  • API production for proprietary therapies
  • Focus on immunology, oncology, and virology APIs
  • Supports drug discovery through commercial scale

Certifications & Regulatory Strength:

  • Operates FDA-inspected facilities
  • Maintains global regulatory certifications

Global Reach:

  • Supplies APIs to affiliated and third-party manufacturers worldwide

9. Amgen Inc.

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.

Key Capabilities:

  • Biologic API manufacturing, including monoclonal antibodies
  • Expertise in biosimilars
  • Advanced bioprocessing and analytics

Certifications & Regulatory Strength:

  • Facilities approved by the FDA and other international bodies
  • Strong compliance record and audit transparency

Global Reach:

  • Distributes biologic APIs across global markets

10. Eli Lilly and Company

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.

Key Capabilities:

  • API production for both chemical and biologic drugs
  • Focus on endocrinology, oncology, and neuroscience
  • End-to-end support from R&D to commercial launch

Certifications & Regulatory Strength:

  • FDA, EMA, and WHO GMP-certified sites
  • Strong internal QA/QC systems

Global Reach:

  • Global supplier of APIs to over 120 countries

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.

Find Trusted API Manufacturers with Chemxpert 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.

Why Chemxpert Database Stands Out:

  • Over 250,000+ product listings covering global based API suppliers
  • Comprehensive data on GMP status, DMFs, plant certifications, and regulatory warnings
  • Smart filters to search by product name, manufacturer, geography, or compliance status
  • Real-time updates on clinical trials, patents, and API pricing

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.

Conclusion

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.

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