Third Party Manufacturing
Third Party Pharma Manufacturing
American Pharma is a leading name in the industry of Third-Party Pharmaceutical Manufacturing in the USA. As a trusted third-party pharmaceutical manufacturer, we specialize in providing top-notch services to pharmaceutical companies looking to outsource their production. With state-of-the-art facilities and an experienced team, we stand out as a premier choice among the USA’s top third-party pharmaceutical manufacturers. Our comprehensive solutions for pharmaceutical contract manufacturing ensure strict adherence to quality standards and regulatory compliance.
At American Pharma, we understand the critical importance of reliability and consistency in the pharmaceutical industry. Our unwavering commitment to excellence has positioned us as a leading Third-Party Manufacturing Company in the USA, dedicated to providing innovative and cost-effective solutions to our valued clients. Whether you require third-party manufacturing services for tablets, capsules, or any other pharmaceutical products, our expertise and fully equipped infrastructure are ready to meet your exact needs.
As a GMP and GLP-certified company, we offer the highest quality products. Our commitment lies in helping you streamline your production processes while maintaining the highest standards of product quality and regulatory compliance.
Third-Party Pharmaceutical Manufacturing Process.
➥ Client Engagement : The process begins when a pharmaceutical company or brand approaches us for third-party manufacturing services. We discuss their product requirements, including formulation, quantity, quality standards, and timelines.
➥ Product Formulation & Specification : The client provides details on the formulation, including active pharmaceutical ingredients (APIs), excipients, and specific product requirements. Our team ensures that all formulations meet regulatory and quality standards.
➥ Regulatory Compliance : We ensure that our facilities and manufacturing processes comply with FDA, WHO-GMP, and other regulatory authorities in the USA or the target market. All necessary licenses and approvals are obtained before production begins.
➥ Raw Material Procurement : We source high-quality APIs and excipients from approved and certified suppliers. All raw materials undergo strict quality checks to ensure they meet safety and efficacy standards.
➥ Production Process : Our advanced manufacturing facilities handle various pharmaceutical processes.
➥ Quality Assurance & Testing : Our quality control (QC) and quality assurance (QA) teams conduct rigorous testing at multiple stages.
➥ Packaging & Labeling : Once the product passes quality checks, we proceed with customized packaging according to client specifications. Labeling follows all FDA and regulatory guidelines, ensuring accuracy and compliance.
➥ Documentation & Compliance : We meticulously document all manufacturing and quality control activities for regulatory compliance and traceability. This ensures transparency and smooth audits.
➥ Delivery & Logistics : The finished pharmaceutical products are securely shipped to the client’s distribution center or designated location as per the agreed terms. We ensure safe and timely delivery.
➥ Regulatory Filing Support (If Required) : In certain cases, we assist clients with regulatory filings, such as New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), depending on the product type and jurisdiction.
At American Pharma, we are committed to delivering high-quality, cost-effective, and regulatory-compliant pharmaceutical solutions to help businesses grow.