Profile: Dr.Reddy's Laboratories Ltd (RDY.N)

RDY.N on New York Stock Exchange

23 Oct 2014
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Dr. Reddy’s Laboratories Limited (DRL), incorporated on February 24, 1984, is an integrated global pharmaceutical company. The Company operates in three segments: Global Generics, Pharmaceutical Services and Active Ingredients (PSAI), and Proprietary Products. On April 1, 2011, the Company launched Peg-grafeel, its brand of pegylated filgrastim (pegfilgrastim). On April 12, 2011, it launched over-the-counter (OTC) fexofenadine hydrochloride tablets. The United States Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for fexofenadine hydrochloride tablets on April 12, 2011. On July 25, 2011, the Company launched gemcitabine for injection (200 milligram /vial and one gram/vial). On July 25, 2011, it launched fondaparinux sodium injection in the United States in collaboration with Alchemia Limited, Australia.

The United Sates FDA gave the approval, on July 11, 2011, of the Company's ANDAs for 2.5 milligram / 0.5 milliliter, 5.0 milligram / 0.4 milliliter, 7.5 milligram / 0.6 milliliter and 10 milligram / 0.8 milliliter doses. DRL manufactures fondaparinux sodium injection under a license using a patented process developed by Alchemia Limited. On August 30, 2011, the Company launched OTC fexofenadine hydrochloride and pseudoephedrine hydrochloride extended release tablets 180/240 milligrams, in the United States. On September 2, 2011, it announced the initiation of clinical trials for dosing with DRL-17822 in patients with diagnosis of type II dyslipidemia. On October 24, 2011, DRL launched olanzapine tablets. On March 2, 2012, it launched ziprasidone hydrochloride capsules in the United States. On March 27, 2012, DRL launched quetiapine fumarate tablets (25 milligram, 50 milligram, 100 milligram, 200 milligram, 300 milligram and 400 milligram) in the United States.

Global Generics

Global Generics segment consists of finished pharmaceutical products ready for consumption by the patient, marketed under a brand name. In India, DRL focus on the therapeutic categories of gastro-intestinal, cardiovascular, pain management and oncology. As of March 31, 2012, it had a total of 249 products in India. During the fiscal year ended March 31, 2012 (fiscal 2012), it launched Velocit pregnancy test kits and Nise gel through its Global Generics segment’s OTC division. Its four brands in Russia includw Nise, Omez, Ketorol and Ciprolet. DRL operates in other countries of the former Soviet Union, including Ukraine, Kazakhstan, Belarus and Uzbekistan. During fiscal 2012, North America (the United States and Canada) accounted for 45% of its total Global Generics segment’s sales. In North America, it sells drugs that are the chemical and therapeutic equivalents. In Germany, the Company sells a range of pharmaceutical products under the betapharm brand. DRL markets its products in the United Kingdom and other European Union countries through its United Kingdom subsidiary, Dr. Reddy’s Laboratories (U.K.) Limited. Its other Global Generics segment includes Venezuela, South Africa and Australia.

Pharmaceutical Services and Active Ingredients

PSAI segment includes active pharmaceutical ingredients (API) and intermediates, also known as active pharmaceutical products or bulk drugs, which are the ingredients for finished pharmaceutical products. This segment also includes contract research services and the manufacture and sale of API and steroids in accordance with specific customer requirements. DRL’s Pharmaceutical Services and Active Ingredients segment is consist of its API business and its custom pharmaceutical services (CPS) business. Through its API and CPS businesses, the Company offer product lines and product services through partnerships internally and externally. As of March 31, 2012, DRL produced and marketed more than 100 different APIs in numerous markets. The Company’s PSAI segment’s API business is operated independently from DRL's Global Generics segment and, in addition to supplying API to DRL’s Global Generics segment, its PSAI segment sells API to third parties for use in creating products. The Company’s PSAI segment’s API business also manufactures and supplies the API requirements of its pharmaceutical services business.

Proprietary Products

Proprietary Products segment involves the discovery of chemical entities and differentiated formulations for subsequent commercialization and out-licensing. This segment also involves its dermatology focused specialty business operated through Promius Pharma. In DRL's Proprietary Products segment, the Company’s business model focuses on building a pipeline in the therapeutic areas of pain management, dermatology and infectious diseases. Its Proprietary Products business is consists of its differentiated formulations business, its new chemical entity (NCE) research business and its dermatology focused Specialty business.

The Company is also focuses on the discovery, development and commercialization of small molecule agents in therapeutic areas, such as bacterial infections, metabolic disorders and pain and inflammation. In its Specialty business it has a portfolio of in-licensed patented dermatology products and off-patent cardiovascular products. The Company also has an internal pipeline of dermatology products that are in different stages of development. As of March 31, 2012, it had 29 active products in the Company’s Proprietary Products pipeline, of which seven were in clinical development. Promius Pharma is its subsidiary in the United States of America focusing on its the United Sates Specialty Business, which is development and sales of specialty products. During fiscal 2012, Promius Pharma launched sales of Cloderm (clocortolone pivalate 0.1%) in the United States. Cloderm is a cream used for treating dermatological inflammation.

The Company competes with Cipla Limited, Ranbaxy Laboratories Limited, GlaxoSmithKline Pharmaceuticals Limited, Cadila Healthcare Limited, Sun Pharmaceutical Industries Limited, Alkem Limited, Mankind Pharma Limited, Pfizer Limited, Abbott India, Lupin Limited, Aristo Pharma Limited, Intas Pharma, Sanofi India Limited, Emcure Pharmaceuticals Limited, Berlin Chemi AG, Gedeon Richter Limited, Krka d.d., Teva Pharmaceuticals Industries Limited, Novartis Pharma A.G., Sanofi-Aventis S.A., Lonza Group, Koninklijke DSM N.V., Albany Molecular Research, Inc., Patheon, Inc., Cardinal Health, Inc. Divis Laboratories Limited, Dishman Pharmaceuticals & Chemicals Limited, Jubilant Organosys Limited, Nicholas Piramal India Limited, Teva Pharmaceutical Industries Limited, Mylan Inc., Watson Pharmaceuticals, Inc., Caraco Pharmaceutical Laboratories Limited, MSN Laboratories Limited, Actavis Group, Stada Arzneimittel AG, Aurobindo Pharma Limited, Mylan Laboratories Limited and Perrigo Company.

Company Address

Dr.Reddy's Laboratories Ltd

Road No.3, BANJARA HILLS, Telang
HYDERABAD     500034
P: +9140.49002900
F: +9140.49002999

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