R & D
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.
Intas’ R & D strategies are focused on 2 major areas:
Pharmaceutical Formulation Development
Intas’ primary focus area in formulation development includes:
- Day 1 launch upon patent expiry
- New drug formulations for existing products for lifecycle management
- Niche Formulations with technology barrier
- Non-infringing formulations under Para-IV/ 505 b (2) categories for launch of products in US prior to the patent expiration
- New drug delivery platforms
Intas’ primary focus area of API development is:
- Vertical Integration in oncology and non-oncology range of products
- Development of non-infringing API to support FTF (first to file) & Para IV filings
- Achieving cost efficiency through process optimization
- Generating IPR on process chemistry
For every new treatment that comes to market, thousands of important discoveries are made along the way contributing to science in a big way. The contribution of these experiences in the development of new technology is invaluable.
Research at Intas is ongoing and with some of the best talents in the Pharmaceutical Industry. Its scientists regularly come up with innovative ideas to fulfill the unmet needs of the Pharmaceutical Market. The niche expertise gathered over a decade of experience in formulation science includes the following platform technologies:
Microsphere technology is aimed at developing formulations providing controlled release of therapeutically active compounds. Microspheres are engineered for controlled release depot injections targeted for drug release from one month up to six months.
Intas has highly sophisticated and fully equipped labs for the development of microspheres and capability to up-scale the process for commercial manufacturing.
Liposomal technology is one of the key tools developed by Intas to address the challenges of undesirable physiochemical properties of drugs which lead to poor pharmacokinetics.
Liposomomal formulations developed in Intas have displayed capability to incorporate hydrophilic and hydrophobic drugs, good biocompatibility, low toxicity, lack of immune system activation, and targeted delivery of bioactive compounds to the site of action.
Sustained Release Formulation Technology
The expertise gathered over the decades of experience in formulation sciences has led to the development of several sustained release products. The sustained release products are helpful in reducing dosing frequency to an extent that once-daily dosing is sufficient for therapeutic management through uniform plasma concentration providing maximum utility of drug with a reduction in local and systemic side effects with improved patient compliance.
Orally Disintegrating Tablet Technology
This is a Drug delivery system designed for rapid disintegration of the product after coming in contact with saliva ensuring faster onset of action. This technology is used for several molecules to facilitate ease of administration and improved patient compliance & convenient dosing for paediatric, geriatric and psychiatric patients with dysphagia.
Intas has expertise in developing advanced inhalation formulation having fundamental advantages in the therapy of diseases of the respiratory tract, including asthma and Chronic Obstructive Pulmonary Disease. The developed inhalation formulations allow a high drug concentration to be achieved selectively in the airways while minimizing systemic side effects. The inhalation formulation aids to achieve quicker action as the medication reaches the targeted area directly, providing faster relief compared to the orally administered product.
Intas has the capability to develop and large-scale manufacture of fast dissolving effervescent tablets. It has adopted this technology to several molecules providing quick relief along with taste masking effect.