Established in 2021, this GMP manufacturer is a leading CTD dossier owner and manufacturer, supplying high-quality pharmaceutical products across multiple countries and regions worldwide. Specializing in cytotoxic products, it operates advanced production lines for liquid injections, lyophilized injections, tablets, and capsules. As a CTD dossier owner and manufacturer, it adheres to strict regulatory standards, holding GMP approvals from WHO cGMP, ISO 9001:2015, and authorities in the Philippines, Cambodia, Kenya, Sri Lanka, and Syria. This GMP manufacturer, as a CTD dossier owner and manufacturer, ensures excellence in pharmaceutical development.

Established in 2004, this pharmaceutical manufacturer specializes in producing liquid orals, cephalosporin tablets, capsules, dry powder syrups, dry powder injections, liquid injectables (SVP) in ampoules and vials, and lyophilized injections. As a CTD dossier owner and manufacturer, it holds multiple GMP certifications, including EU GMP, ISO 9001:2015 (BVQI), WHO-GMP, and cGMP. Additionally, its facilities are approved by national drug authorities in countries such as Uganda, Kenya, Yemen, Ethiopia, Congo, Ghana, Zimbabwe, Cambodia, Vietnam, Malawi, Namibia, Nigeria, Côte d'Ivoire, the Philippines, and Peru. The manufacturer operates advanced production lines adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across over 50 countries globally, with 292 registered products and an additional 210 products under registration.

This privately held company develops, manufactures, and commercializes high-quality, affordable generic pharmaceuticals globally. Their focus is on products with formulation challenges and first-to-market opportunities within the generic space. Key therapeutic areas include those requiring complex formulations like injectables, sterile ophthalmic, and dermal products. They specialize in solid oral dosage forms through partnerships with other manufacturing facilities. The company holds GMP certifications and has a track record of developing patented product formulations. Their main production facility in North America is equipped for multi-format packaging and end-product release testing, ensuring a seamless process from bulk manufacturing to finished goods.