Amneal’s product pipeline represents a diversified range of products across multiple therapeutic areas and dosage forms, including a sizable proportion of complex, high barrier-to-entry and difficult-to-formulate products. It has eight proprietary research and development facilities located in New York, New Jersey and India, focusing on several product categories in various stages of development. The company’s portfolio now includes more than 100 U.S. FDA-approved molecules, more than 100 molecules pending approval and another 200 in development.
The Amneal product pipeline affords broad coverage of therapeutic areas including cardiovascular, central nervous system/pain, oncology, inflammation, anti-infective, dermatology, endocrinology, diabetes, rhinology, urology, and hematology, among others.
Topical products are medications that are applied directly to the skin to provide a therapeutic effect on a localized area and, in some cases, for systemic absorption. In the last few years, Amneal has been developing these dosage forms, which include gels, creams, ointments, and topical solutions for the treatment of various conditions such as pain, inflammation and infections. Obtaining equivalence to originator product across multiple product characteristics such as appearance, odor, texture and viscosity, in addition to developing a robust manufacturing process, is critical to develop generic topical products.
Amneal is working on several drug-device combination products such as pen devices, auto-injectors, meter dose and dry powder inhalers, intra-uterine devices and inserts, and dosage form applicators, across several therapeutic areas. They provide unique solutions, offering convenience and compliance to patients for chronic and acute indications. Similar to other complex products in Amneal’s portfolio, these products have complex design requirements and require multiple functional proficiencies and dedicated manufacturing infrastructure. Additionally, they have complex processing requirements including clinical and pharmacokinetic studies and other specific regulatory aspects — all of which Amneal is well-positioned to deliver.
Transdermal products deliver medications through the skin for systemic rather than topical distribution. Amneal has invested significantly in R&D and production capabilities in the United States to develop and manufacture transdermal products across the matrix and hydrogel patch platforms. The products within this category draw on several functional proficiencies such as physical chemistry, polymers and adhesives, chemical and process engineering. In addition to pharmacokinetic studies, the bio-studies for these products also include demonstration of comparable skin irritation and adhesion to the originator product.
Amneal’s portfolio of oral liquids includes solutions, emulsions and suspensions. These includes several complex formulations inclusive of high dose, polymeric matrices and particle technology-driven products.
Amneal’s pipeline of ophthalmic products includes steroidals, non-steroidals, antibiotics and combinations to treat pain and inflammation of the eyes in solution, suspension, emulsion, gel and ointment presentations. Since these drugs are highly complex and require specialized infrastructure, Amneal has dedicated R&D teams in India and the United States focused on developing and formulating ophthalmic products.
Amneal’s portfolio of injectable products include diverse categories of molecules composed of general injectables, oncology injectables and complex injectables. The dosage forms consist of solutions, suspensions and aseptic lyophilized powders in vial and PFS presentations. The complex injectable pipeline includes difficult-to-formulate products such as microspheres, peptides, liposomal and nanotechnology driven products. These molecules in general require a high degree of characterization and structural sameness studies and, in many cases, pharmacokinetic and patient-based clinical endpoint studies. Amneal has built dedicated state-of-the art, FDA-compliant sterile facilities to develop and manufacture these niche products.