Research and Development for the future

Our Partnership

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

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

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

Capabilities

Generics

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.

API

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 of available API’s, so do their technologies that support QC analytical capabilities. Diligent global raw materials are sourced and GMP’s qualified and manufactured at international cGMP API facilities.

Differentiated Products

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 are in various stages of development. Their skilled scientists are engaged in the development of complex injectable products. The research centre continually seeks to expand its technical capabilities into new dosage forms and deliveries that are more convenient, compliant, and effective.

Bioequivalence / Bioavailability Study Center

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. The centre conducts bioequivalence and bioavailability studies on healthy volunteers to prove the safety and effectiveness of developed formulations for various regulatory agencies world-wide. The facility has successfully satisfied multiple inspections by some of the world’s most stringent regulatory bodies including DCGI, USFDA, UK-MHRA, NPRA, ISP-Chile. Alkem has received many product approvals from various countries’ regulatory bodies, successfully completing bioequivalence studies. 

Achievements

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.

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