People Process Products CPC Cares News Careers Connect OUR FORMULA FOR YOUR SUCCESS CPC is a leader in contract manufacturing and pharmaceutical development thanks not only to our experience and commitment to quality but also to our innovative process that keeps everything in motion. It’s a process that ensures superior over-the-counter drugs, dietary supplements, and solid-dose Rx pharmaceuticals—no matter the size, scale, or scope of the product. VIEW OUR PROCESS INVESTING IN INDUSTRY-DEFINING TECHNOLOGIES When you’re renowned for on-time delivery and superior quality, it’s imperative you use state-of-the-art innovations and equipment to get you there. That’s why we’re committed to using only the best processing equipment available today. From computerized Bosch and IMA capsule-filling machines to fully-automated Fette tablet presses, our investment in innovative technologies ensures quality, consistency, and on-time delivery for every product we manufacture. INNOVATION IN THE LAB. INNOVATION IN PRODUCTS. Our analytical chemists develop and validate laboratory methodologies, monitor ongoing stability, and support the formulation and manufacturing process that accelerates commercialization and elevates pharmaceutical development to a new level. Method development and validation Cleaning residuals development and validation Dissolution and drug release profiling Forced degradation studies Stability monitoring to ICH guidelines EXPERTS IN MEETING AND EXCEEDING REGULATORY REQUIREMENTS The regulatory process is complicated. Our decades of experience help you navigate it to ensure a successful product launch and life cycle. Our team of experts are trained and highly knowledgeable about regulatory requirements in worldwide markets. They work closely with our customers around the globe to prepare both U.S. FDA and international dossiers. Our team monitors FDA regulations to ensure our strict compliance with current Good Manufacturing Practices (cGMPs) Regulatory support for Abbreviated New Drug Application (ANDA) New Drug Application (NDA) and 505(b)(2) submissions Change control and support of post-approval commitments Post-approval stability testing and monitoring of product quality People Process Products CPC Cares News Careers Connect WE CAN HELP YOU 165 Oser Avenue Hauppauge, NY 11788 T 631.231.4610 F 631.231.4156 info@cpc.com Sitemap | © 2010-2021 Contract Pharmacal Corp. All Rights Reserved