Chartwell Pharmacutical
Chartwell Pharmaceutical operates four main manufacturing and analytical campuses in the New York metropolitan area, producing a wide range of generic prescription pharmaceuticals. The company is fully cGMP compliant, markets products under the Chartwell RX label, and is actively expanding its product pipeline and capabilities.
Manufacturing Locations
Chartwell Pharmaceutical operates four main manufacturing and analytical campuses in the New York metropolitan area. The headquarters is situated at 77 Brenner Drive, Congers, NY 10920. Additional notable facilities include locations at 219 Dixon Ave, Amityville, NY 11701, and 1033 Stoneleigh Ave, Carmel Hamlet, NY 10512. These sites are fully compliant with current Good Manufacturing Practice (cGMP) standards, ensuring the highest quality in pharmaceutical production.
Product Offerings
Chartwell Pharmaceutical produces a wide range of generic prescription pharmaceuticals. Their product lineup includes various dosage forms such as tablets, capsules, powders, solutions and suspensions, semi-solids, ophthalmics, otics, and the upcoming injectable forms. These products are marketed under the Chartwell RX label. The company's facilities leverage sophisticated technologies to maintain compliance with FDA standards and international trade agreements.
Compliance and Regulatory Adherence
Chartwell Pharmaceutical ensures full compliance with the Trade Act Agreement (TAA) and the Buy American Act (BAA). Additionally, their facilities meet the rigorous standards of cGMP. The company has over 900 FDA-approved prescription listings in the Orange Book, showcasing their commitment to regulatory adherence and quality control.
Product Pipeline and Development
Chartwell Pharmaceutical has a robust product pipeline, with over 700 Orange Book listings. The company is focused on expanding its product offerings, with more than 20 product launches anticipated in the next nine months. Development efforts also include new 505(b)(2) products and additional dosage forms. Recent acquisitions and expansion initiatives have strengthened their pipeline, positioning the company for further growth.
Government Contracts and Sales
Chartwell Pharmaceutical is well-prepared to sell to government entities and supply both state and federal contracts. The company's compliance with TAA and BAA regulations makes it a reliable partner for government contracts. Aggressive efforts in product acquisition indicate a strategic focus on expanding their market presence and enhancing their product offerings to meet government needs.