|Business Areas : Research|
Our in-house research and development capabilities are the cornerstone of our operations and continued growth. Our research and development teams focus on API, pharmaceutical products and biopharmaceutical development and are divided between the Domestic Market, the Regulated Markets and the Rest of World markets. Our research team, which, as of March 31, 2013, consists of over 400 scientists, 47 of which hold Ph.D.s, focuses on developing complex APIs, finished formulations and biosimilars by using our chemistry, biologics, analytical, regulatory and intellectual property expertise. We conduct research and development activities at eight dedicated R&D centers located in Bhosari, Pune; Hinjewadi, Pune; Pimpri, Pune; and East Brunswick, New Jersey. We have two centers focused on API research, four on formulation products and two centers working on biotechnology research.
We have filed ANDAís for several of our products, which include solid orals, soft gel and extended release products. Most of the DMFs filed are for in-house pharmaceutical products. Some of our key DMF filings are acamprosate calcium, argatroban, cidofovir, enoxaparin, raltegravir potassium, sevelamer carbonate, sevelamer hydrochloride, sodium ferric gluconate and zileuton. Some of the key DMFs in oncology are busulfan, carmustine, cyclophosphamide, decitabine, docetaxel, gemcitabine, irinotecan, melphalan oxaliplatin and topotecan.
R&D Capabilities: API
As API research is the starting point for most of our initiatives in pharmaceutical products, we develop multiple synthetic routes for the same molecule and choose the route that is most robust and cost effective and matches innovator product specifications. Our scientists have expertise in chiral chemistry, polymer based chemistry, peptides chemistry and complex products.
Chiral Chemistry :
We believe that we are leaders in chiral chemistry. We believe that chirality produces many benefits, which ultimately improve the efficacy and safety of treatment. For example, chirality increases receptor selectivity and potency, which reduces the required dosage (and metabolic load on the patientís body) and in many cases enhances the pharmacological effects. Also, chirality in many cases reduces adverse effects and the potential for drug interactions because chirality removes the inactive isomer.
Polymer Based Chemistry :
We are one of the few companies to have leveraged the technology and commercialized APIs based on polymer based chemistry, including Sevelamer HCL and Sevelamer carbonate in India
Peptides Chemistry :
Peptides chemistry allows us to explore new areas of peptides research, such as high end separation and characterization for development of peptides in both solid and solution state. Our peptides chemistry research team carries out sophisticated characterization of all molecules to ensure their structures, purity and potency.
Complex Products :
These products have complex structures that require special skills to develop. Unlike a majority of injectables products, these complex molecules require sophisticated characterization and bio equivalence studies mandated by USFDA. We have already developed and commercialized some of these products in the Domestic Market, such as iron preparations and low molecular weight heparin.
Our pharmaceutical products research team offers a portfolio of differentiated drugs and we have the ability to handle multiple dosage forms such as:
- Solid dosage pharmaceutical products (capsules, effervescent tablets, softgels, tablets for immediate release or extended release);
- Injectables (sterile solutions and anticancer injectables);
- Lyophilized pharmaceutical products (including lyophilized cytotoxic injectables);
- Novel pharmaceutical products (suspension and emulsion injectables, liposomes and nanoparticles for injection);
- Oral liquids (syrups, suspensions);
- Topical pharmaceutical products (sprays, patches, ointments); and
- Respiratory (inhalers).
Our primary objective in pharmaceutical products research is to develop and launch niche products with limited competition and high entry barriers.
First to market opportunities in the Domestic Market :
Our domestic pharmaceutical products research team has a proven record in speed to market, having launched several pharmaceutical products for the first time in India, including dapoxetine, troxipide and ferric carboxymaltose and most of our range of chiral molecules such as S-amlodipine, S-metoprolol and S-atenol.
Novel drug delivery systems :
We are developing novel drug delivery systems based on the liposomal and nanotechnology platforms. We have identified several antifungal, antibiotic and oncology products that will be developed and commercialized using these platforms and are currently developing a few . We believe that these platforms will benefit patients by reducing in vivo toxicity.
Wide range of dosage forms :
We have in-house capability to develop a wide range of dosage forms. For solid orals, we have the capabilities to develop products with controlled release pharmaceutical products, taste masking, orally dissolving tablets and soft gels formulations. For injectables, we handle liquids, lyophilized and sterile powder fill in vials as well as pre-filled syringes. Our injectable portfolio includes complex iron injectables, oncology, steroids, suspensions and emulsions.
Paragraph IV opportunity in the United States :
We develop pharmaceutical products that are candidates for Paragraph IV to gain early market access in the United States.