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Pharmaceutical Sciences Experts

Urmish Hasmukh Chudgar


Biopharmaceutical
Intas Biopharmaceuticals
India

Biography

 The Biologics Business Unit (BU) of Intas Pharmaceuticals Limited was formerly an independent biotechnology company and was known as Intas Biopharmaceuticals Ltd. Intas Pharmaceuticals limited is an Indian company headquartered in Ahmedabad, India. The Biologics BU is located in Moraiya, Ahmedabad and is one of the leading biosimilar product manufacturers in Asia. The Biologics BU of Intas Pharmaceuticals has biopharmaceutical operations with R&D facility and an EU-GMP certified bio-pharmaceutical manufacturing facility.

Research Interest

 Headed by a strong pool of 400+ scientists and researchers, R & D is the key growth driver for Intas. Its constant quest for developing new products and technology has led breakthrough innovations in a wide spectrum of areas such as Oncology, hormones & NDDS, apart from other generic products. Till date, Intas has filed 50+ patents on novel formulations, API polymorphs/processes & analytical methods to its credit. Intas' continuous R & D initiatives have strengthened its product basket with delivery of niche and complex products. Intas is extensively working on Para IV and 505 (b) 2 products for USA market and few products are already filed with USFDA. Intas targets to file more than 5 Para IV applications to US market each year. Intas Pharmaceuticals is engaged in research, development and commercialization of novel therapeutic products for the treatment of cancer, infectious diseases and acute medical emergencies. The company in collaboration with US based Jina Pharmaceuticals Inc. has developed a clinically validated proprietary Nanoaqualip™ technology to formulate drug products. The newly formulated drugs are less toxic with improved bioavailability and better therapeutics. Based on Nanoaqualip™ technology the company is enhancing broader applications of generic drugs, difficult to formulate drugs and drugs of which the patent rights are near expiration through the development of improved delivery system. Intas is actively involved in the development and commercialization of biologics. Since inception, 8 biologics have been commercialized in India and around 15 biologics are at different stages of development. The highly qualified and capable R&D, focuses on the biosimilar product development keeping the European and the US Regulatory guidelines in the view. One of the assets is under registration with the EU authority and another at advanced stage of clinical development in the European region. The company is also focused on discovery and development of New Chemical Entity (NCE’s) targeting cancer and neurodegenerative diseases such as bipolar disorder. The molecule has completed Phase-Ib Clinical Studies & entering into Phase-II Efficacy Studies.

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