Profile: Dr.Reddy's Laboratories Ltd (RDY.N)
27 Feb 2017
Dr. Reddy's Laboratories Limited, incorporated on February 24, 1984, is a pharmaceutical company that is engaged in providing medicines. The Company operates in three segments: Global Generics, Pharmaceutical Services and Active Ingredients (PSAI), and Proprietary Products. The Global Generics segment consists of its business of manufacturing and marketing prescription and over-the-counter finished pharmaceutical products ready for consumption by the patient, marketed under a brand name (branded formulations) or as generic finished dosages with therapeutic equivalence to branded formulations (generics). PSAI segment includes the Company's business of manufacturing and marketing active pharmaceutical ingredients and intermediates (API) or bulk drugs. Proprietary Products segment focuses on the research, development and manufacture of differentiated formulations and new chemical entities (NCEs). These products fall within the dermatology and neurology therapeutic areas, and are marketed and sold through its subsidiary, Promius Pharma, LLC. Others include the operations of its subsidiary, Aurigene Discovery Technologies Limited, a discovery-stage biotechnology company developing therapies in the fields of oncology and inflammation.
Global Generics segment
Global Generics segment includes the operations of its biologics business. The segment offers branded and unbranded drug products. Its Global generics segment includes various regions, such as India, Russia and Other Countries of the Former Soviet union, North America (the United States and Canada), Europe and Rest of the World markets. Its Rest of the World markets include Venezuela, South Africa and Australia. In India, the Company's therapeutic categories include gastro-intestinal, cardiovascular, pain management and oncology. It has also its presence in the areas of dermatology, urology and nephrology. As of March 31, 2016, the Company had a total of 296 branded products in India.
In Russia, the Company's brands include Nise, Omez, Ketorol and Cetrine. Omez is an anti-ulcerant product. Nise and Ketorol are pain management products. Cetrine is a respiratory product. In Russia, the Company is focused on the gastro-intestinal, pain management, anti-infectives, respiratory, oncology and cardiovascular therapeutic areas. The Company operates in other countries of the former Soviet Union, including Ukraine, Kazakhstan, Belarus, Uzbekistan and Romania. In the United States, the Company sells generic drugs that are the chemical and therapeutic equivalents of reference branded drugs. In Germany, it sells a range of generic pharmaceutical products under the betapharm brand. The Company markets its generic products in the United Kingdom and other European Union countries through its subsidiary, Dr. Reddy's Laboratories (U.K.) Limited.
Pharmaceutical Services and Active Ingredients segment
The Company's PSAI segment comprises its API business and Custom Pharmaceutical Services (CPS) business. It is also engaged in the manufacture and sale of steroids. The Company produces and markets over 100 different APIs for various markets. PSAI segment's API business is operated independently from its Global Generics segment and, in addition to supplying API to its Global Generics segment, PSAI segment sells API to third parties for use in manufacturing generic products. The Company exports API to over 80 countries, and principal overseas markets include North America (the United States and Canada) and Europe. API business also manufactures and supplies the API requirements of its pharmaceutical services business.
Proprietary Products segment
The Company has an internal pipeline of differentiated products in dermatology and neurology products in various stages of development. In addition, the Company has the commercial portfolio of in-licensed dermatology products. The Company's NCEs business is focused on the discovery, development and commercialization of small molecule agents in therapeutic areas, such as metabolic disorders, pain and inflammation. As of March 31, 2016, the Company had 19 active product development programs in its pipeline. The Company's products in Phase III development include DFN-02, DFD-01 (Sernivo), DFD-06, DFN-11 (Zembrace), DFD-09 (Zenavod), DFD-10, DFD-11 (Xeglyze), XP 23829 and E7777.
DFN-02 is used in acute treatment of migraines, with or without aura in adults. DFD-01 (Sernivo) is used to treat mild to moderate plaque psoriasis in patients of over 18 years of age. DFD-06 is used to treat moderate plaque psoriasis in patients over 18 years of age. DFN-11 (Zembrace) is used in aute treatment of migraine with or without aura in adults.
DFD-09 (Zenavod) is used in treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. DFD-10 is used to treat acne in patients of over 12 years of age. DFD-11 (Xeglyze) is used in the treatment of head lice in patients of over 6 months of age. XP 23829 is used to treat plaque psoriasis in patients of over 12 years of age. E7777 is used to treat Cutaneous T Cell Lymphoma.
Promius Pharma LLC has a portfolio of in-licensed patented dermatology products. It also has an internal pipeline of dermatology products that are in different stages of development Promius Pharma LLC's portfolio contains products for the treatment of seborrheic dermatitis, acne and steroid responsive dermatoses. It has commercialized six products: EpiCeram, a skin barrier emulsion for the treatment of atopic dermatitis; Scytera, a foam for the treatment of psoriasis; Promiseb, a cream for the treatment of seborrheic dermatitis; Cloderm, a cream used for treating corticosteroid-responsive dermatoses; Trianex, a cream for the treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; Zembrace SymTouch, an autoinjector for treatment of migraine headaches, and Sernivo, a spray for the treatment of mild to moderate plaque psoriasis. Promius Pharma LLC also markets and promotes Zenatane (isotretinoin).
The Company competes with Cipla Limited, GlaxoSmithKline Pharmaceuticals Limited, Cadila Healthcare Limited, Sun Pharmaceutical Industries Limited, Piramal Enterprises Ltd, 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 Pharmaceutical Industries Limited, Lek-Sandoz Pharmaceuticals, Ranbaxy Laboratories Limited, Nycomed International Management GmbH, Zentiva N.V., Mylan Inc., Novartis Pharma A.G., Endo Pharmaceuticals, Sun Pharmaceuticals Limited, Perrigo, Winthrop Arzneimittel GmbH, Stada Arzneimittel AG, Divis Laboratories Limited, Aurobindo Pharma Limited, Mylan Laboratories Limited, MSN Laboratories Limited, Dishman Pharmaceuticals & Chemicals Limited, Jubilant Organosys Limited, Nicholas Piramal India Limited, Lonza Group, Koninklijke DSM N.V., Albany Molecular Research, Inc., Patheon, Inc. and Cardinal Health, Inc.
Dr.Reddy's Laboratories Ltd
8-2-337, Road No.3 Banjara Hills
Company Web Links
- BRIEF-Dr.Reddy's Labs gets form 483 with 3 observations from USFDA for audit of Miryalaguda plant
- BRIEF-Dr.Reddy's Labs says no claims against co for monetary damages
- BRIEF-Dr Reddy's says U.S. court finds co's product infringes some patents
- BRIEF-Dr.Reddy's Labs says co not served with legal papers in matter as in Mezzion's press release
- BRIEF-Dr. Reddy's Labs says U.S. FDA re-audit of co's plants part of "usual activity"