AMPAC Fine Chemicals (AFC) an SK pharmteco Company, is a United States-based, custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates.  As part of the SK pharmteco group, we solve problems through technology and innovation to reliably deliver quality products that save and improve lives. With over 80 years of experience, we have mastered challenging chemistries, enabling us to provide the highest quality services to our customers.

Our fully cGMP compliant facilities located in California, Texas, and Virginia specialize in process development, scale-up, and production from kilograms to multi-tonne quantities. We also have standalone contract analytical services labs. These services are conducted at AMPAC Analytical, located near our headquarters in California.

State-of-the-art technology platforms include:

    *  Commercial-scale production utilizing hazardous / energetic chemistries
    *  High-containment facilities for the production of high-potency APIs (HPAPIs) and intermediates
    *  Chromatographic separations using simulated moving bed (SMB) technology
    *  Continuous processing
    *  Controlled Substances and Specialized chemical capabilities
    *  Analytical Laboratory Services

Chemicals

Life Sciences

Pharmaceutical

AMPAC Fine Chemicals

AMPAC Fine Chemicals' headquarters in Rancho Cordova, CA, United States

This department focuses on the development and optimization of processes for research and production.

Process Development

The Process and Engineering team at AMPAC Fine Chemicals (AFC) is responsible for developing, optimizing, and scaling up chemical processes for the manufacture of active pharmaceutical ingredients (APIs) and registered intermediates. This team utilizes cutting-edge technology and extensive expertise in hazardous chemistries, high-potency APIs, continuous processing, and chromatographic separations to ensure robust, efficient, and compliant production. By integrating advanced engineering solutions, they play a critical role in delivering high-quality pharmaceutical products that meet stringent regulatory standards.

Process and Engineering

The Quality and Regulatory Affairs Team at AMPAC Fine Chemicals ensures compliance with all relevant regulations and industry standards for the manufacture of APIs and intermediates. They oversee quality control and assurance processes, conduct audits, manage regulatory submissions, and coordinate with regulatory bodies to ensure that all produced substances meet the highest quality standards. This team is integral in maintaining cGMP compliance across all facilities and guarantees that all products consistently meet rigorous safety, efficacy, and quality requirements.

Quality and Regulatory Affairs Team

The Management team at AMPAC Fine Chemicals is responsible for overseeing all strategic and operational aspects of the company. This includes directing process technologies and drug product management, ensuring safety, health, and environmental compliance, managing site general operations, planning and logistics, engineering efforts, strategic sourcing, R&D in API manufacturing, and regulatory affairs. The team works collaboratively to drive innovation, maintain high-quality standards, and ensure efficient production and delivery of active pharmaceutical ingredients and intermediates.

Management

The Manufacturing and Maintenance team at AMPAC Fine Chemicals is responsible for the seamless operation of the manufacturing facilities and the upkeep of equipment critical for the production of active pharmaceutical ingredients and intermediates. This team ensures compliance with cGMP standards, manages the scale-up process from development to commercial-scale production, and addresses any technical issues that arise. With specialized roles such as Manufacturing Directors, Maintenance Managers, and Specialists, they play a vital role in maintaining the efficiency, safety, and quality of our production processes across sites in California, Texas, and Virginia.

Manufacturing and Maintenance

The Accounting and Finance team at AMPAC Fine Chemicals is responsible for managing the company's financial health and ensuring accurate financial reporting. This includes budgeting, financial planning and analysis, internal audits, and compliance with financial regulations. The team plays a critical role in strategic decision-making by providing insights into financial performance and projections to support the company’s goals of delivering high-quality pharmaceutical products.

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Process and Engineering

Quality and Regulatory Affairs Team

Management

Manufacturing and Maintenance

Accounting and Finance