Alkem Laboratories research and development centre has filed over 140 ANDAs with the USA FDA, close to 60 products with TGA Australia, around 30 products for EU and many dossiers in other countries includingBrazil, South Africa, Canada, Chile, and the rest of the world. Their fantastic reputation for quality and capability is made possible by their world class manufacturing facilities and their research and development capacity.
Their Intellectual Property (IP) team provides strongsupport for their research strategy and the products we launch in Australia.The IP team possesses expertise in chemistry, analytical techniques, dosageforms and global patent laws. Over the last decade, they have consistently challengedpatents on several high-value products in Australia as well as in the US withFirst-to-File exclusivity under Hatch-Waxman Act. This helps us in providinghigh-quality generic versions of products at competitive prices.
Alkem Laboratories objective is to introduce innovative, state of the art products and to develop niche complex products. Their range includes oral solids, controlled substances, complex generics, oral liquids, topical, injectable and transdermal products. evelop niche complex products. The product range includes oral solids, controlled substances, complex generics, oral liquids, topical, injectable and transdermal products.