Through our partnership with Alkem Laboratories, we are committed to achieving our vision of a sustainable and equitable healthcare system, enriching quality of life in patients’ lives. Alkem Laboratories supports our business by developing novel generic formulations, allowing us to provide non-infringing generics to Australia patients.
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 including Brazil, 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 strong support for their research strategy and the products we launch in Australia.The IP team possesses expertise in chemistry, analytical techniques, dosage forms and global patent laws. Over the last decade, they have consistently challenged patents on several high-value products in Australia as well as in the US with First-to-File exclusivity under Hatch-Waxman Act. This helps us in providing high-quality generic versions of products at competitive prices.
Alkem Laboratories have a team of over 500 highly specialised researchers stationed across six different R&D centres in India and the USA. Their researchers power the development of generics, bio similars, transdermal drug delivery systems, oral films, and technology intensive products like Novel Drug Delivery Systems (NDDS) that are difficult to produce. As well as this, Alkem have a dedicated team for process and packaging development.Below is a list of our research facilities with their locations:
Alkem Research Centre, Taloja, Navi Mumbai, Maharashtra
Alkem Research Centre, Mandva, Gujrat
Enzene Biosciences Limited, T-Block, MIDC, Bhosari, Pune, Maharashtra
Enzene Biosciences Limited, MIDC, Bhosari, Pimpri-Chinchwad, Pune, Maharashtra
Alkem Laboratories, Fenton, MO, USA
Norac Pharma, Azusa, CA, USA
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. Develop niche complex products…
Alkem Laboratories research, develop, and manufacture world-class active pharmaceutical ingredients (API). Their comprehensive tools for analysing processes and safety assessment ensure the highest international regulations, compliances and standards are met. As they broaden and grow their portfolio…
Alkem Laboratories research centres focus on the development of specialty products with new dosage form or repurpose indications as 505(b)(2) for the USA and India. Differentiated products such as nasal sprays, oral sprays, topical lotions, transdermal patches, oral films, osmotic drug delivery systems, MUPS…
Alkem’s Bioequivalence centre is an independent clinical research organisation surpassing global standards. The state-of-the-art facility is equipped with 112 beds, an in-house emergency care unit, and well-appointed bioanalytical laboratory...
Our R&D Centre has developed products and filed over 140 ANDAs with USA FDA, close to 60 products with TGA Australia, around 30 products for EU and many dossiers in other countries including Brazil, South Africa, Canada, Chile and rest of the world. Our research capabilities has paid dividends not only in terms of business but with an enviable reputation for quality and capability.
Our research strategy and implementation is strongly supported by our proficient Intellectual Property (IP) team. Our IP team commands a strong expertise and hold rich experience in chemistry, analytical techniques, dosage forms and global patent law. Over the last decade, we have been consistently challenging patents on several high-value products in Australia as well as in the in the US with First-to-File exclusivity under Hatch-Waxman Act. This helps us in furnishing high-quality generic versions of such products at reasonable costs. Our IP team continuously strives to capture new developments across the company and protects them as an intellectual property.
