Established in 2008, the manufacturer excels as a CTD dossier owner and manufacturer, distributing its pharmaceutical products across multiple countries. Renowned as a GMP manufacturer, it employs state-of-the-art production lines specifically designed to meet stringent quality standards, essential for a CTD dossier owner and manufacturer. This underscores their commitment to excellence and safety in drug manufacturing, ensuring they maintain their status as a leading CTD dossier owner and manufacturer.

 

 

 

 

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.

This company is a leading manufacturer of human-derived gonadotropins, with over five decades of experience in the field. They offer a wide range of products, including Human Chorionic Gonadotropin (HCG), Follicle Stimulating Hormone (FSH), and Luteinizing Hormone (LH). The company specializes in infertility drugs used for assisted reproductive technology (ART) like In-Vitro Fertilization (IVF). They also produce sex hormones such as progesterone and testosterone. Their expertise extends to contract manufacturing, making them a partner for many global pharmaceutical brands. They hold EU GMP certifications and have the capacity to produce over 10 million vials annually. The company operates in emerging markets and is expanding into highly regulated regions like the North America and EU.