Dr Reddy's Laboratories Ltd (DRL) is an integrated global pharmaceutical company committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services &Active Ingredients Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including Active Pharmaceutical Ingredients (APIs) custom pharmaceutical services generics biosimilars and differentiated formulations. The company's major therapeutic areas of focus are gastrointestinal cardiovascular diabetology oncology pain management and dermatology. Dr. Reddy's operates in markets across the globe. Its major markets include - USA India Russia & CIS countries and Europe.Dr Reddy's Laboratories was incorporated in the year 1984 in Hyderabad. The company was established by Dr Anji Reddy with an initial capital outlay of Rs 25 lakh. The company made their beginning with the manufacture of Active Pharmaceutical Ingredients and Intermediates (API) and commenced operations with a single drug in a 60-tonne facility near Hyderabad India. In the year 1986 the company shares were listed on the Bombay Stock Exchange. Also they entered international market with exports of Methyldopa.In the year 1987 the company obtained first USFDA approval for Ibuprofen API. In the year 1988 they acquired Benzex Laboratories Pvt Ltd to expand their Bulk Actives business. In the year 1990 they exported Norfloxacin and Ciprofloxacin to Europe and Far East. In the year 1991 they commenced formulation exports to Russia.In the year 1993 the company established Dr. Reddy's Research Foundation and initiated drug discovery programme. In the year 1994 they finished dosages facility established to cater to highly regulated markets such as the US. In the year 1995 the company set up joint venture in Russia. In the year 1997 they filled first ANDA with the United States Food and Drug Administration for Ranitidine. In the year 1999 the company acquired American Remedies Ltd a pharmaceutical company based in India. In the year 2000 Cheminor Drugs Ltd a group company merged with the company and thus the company became India's third largest pharma company. In the year 2001 the company launched Fluoxetine capsules. They became the first Indian company to win 180-day exclusivity for a generic drug in the US. Also they launched their first generic product Ranitidine in the US market.In the year 2002 the company made their first overseas acquisition of BMS Laboratories Limited and Meridian Healthcare in UK. In the year 2003 they launched Ibuprofen first generic product to be marketed under the 'Dr. Reddy's' label in the US. In the year 2005 they acquired Roche's API Business at its manufacturing site in Mexico. In the year 2006 the company acquired Betapharm the fourth largest generics company in Germany for a total enterprise value of Rs 480 million. In the year 2007 the company launched Reditux - the world's first biosimilar MAb - for the treatment of Non Hodgkins Lymphoma. Also they became India's leading and most profitable pharmaceutical company.During the year 2008-09 the company acquired DowPharma's small molecules business in UK under Chirotech Technology Ltd BASF Corporation's manufacturing facility at Shreveport in Louisiana USA under Dr. Reddy's Laboratories Louisiana LLC and Jet Generici SRL a company engaged in the sale of generic finished dosages in Italy. In addition Perlecan Pharma Pvt Ltd Macred India Pvt Ltd and Dr. Reddy's Laboratories ILAC Ticaret also became subsidiary of the company.During the year 2009-10 Dr. Reddy's Pharma SEZ Ltd was incorporated as a wholly-owned subsidiary of the company for the purpose of formulation manufacturing at Special Economic Zone and Perlecan Pharma Pvt Ltd was amalgamated with the company. Further the company acquired the balance stake of 30% in Dr. Reddy's (Australia) Pty Ltd. The company filed 12 Abbreviated New Drug Applications (ANDAs) in US including six Para IV filing during the year.During the year 2010-11 the company acquired GlaxoSmithKline's (GSK) oral penicillin manufacturing facility located in Tennessee USA. This allows the company to enter theUS penicillin-containing antibacterial market segment through brands such as Augmentin and Amoxil and serve the needs of customers through manufacturing and other capabilities that did not previously exist within the company. Also they increased the stake in the South African joint venture company to 100% after acquiring the 40% stake of the partner.During the year the company launched Cresp in India the first biosimilar darbepoetin alfa in the world. In March 2011 they launched Peg-grafeelTM in India in the form of an affordable pegfilgrastim which is used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. Peg-grafeelTMDuring the year Idea2Enterprises (India) Pvt Ltd Dr. Reddy's Laboratories Romania SRL I-Ven Pharma Capital Ltd Dr. Reddy's Laboratories Tennessee LLC and Dr. Reddy's Venezuela C.A. became wholly-owned subsidiaries of the company. Further Dr. Reddy's Laboratories (Proprietary) Ltd also became wholly-owned subsidiary by virtue of purchase of its balance 40% stake by the company. Also Macred India Pvt Ltd ceased to be a subsidiary of the company.On 27 July 2012 Dr. Reddy's Laboratories announced that the United States Food and Drug Administration (USFDA) had lifted import alert on its chemical manufacturing facility at Cuernavaca Mexico after inspection of the unit in March 2012. Earlier Dr. Reddy's Mexico facility was inspected by USFDA in November 2010 and based on observations by the USFDA a warning letter was issued to the company on 14 June 2011.On 8 October 2012 the Custom Pharmaceutical Services (CPS) business of Dr. Reddy's Laboratories Ltd. announced expansion in the areas of activated mPEG manufacturing and in the development and manufacture of NCE (New Chemical Entities) APIs for use in pre-clinical through to commercial development at its manufacturing facility in Mirfield UK.On 14 December 2012 Dr. Reddy's Laboratories announced that it had launched the recommended public offer to acquire all the issued and outstanding shares of OctoPlus N.V. a service based specialty pharmaceutical company at an offer price of EUR 0.52 (cum dividend) per share. Shareholders (including certain members of the Boards) holding in aggregate 63.5% of the issued and outstanding ordinary shares of OctoPlus entered into irrevocable undertakings to tender their shares under the offer. On 28 February 2013 Dr. Reddy's Laboratories announced that it had raised its stake in OctoPlus N.V to 98.6% following a public offer for all the issued and outstanding ordinary shares in the capital of OctoPlus. OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries with a focus on difficult-to formulate active pharmaceutical ingredients.On 19 December 2014 Dr. Reddy's Laboratories announced that it had completed the acquisition of Habitrol brand (an over-the-counter nicotine replacement therapy transdermal patch) from Novartis Consumer Health Inc. following issuance of the proposed consent order from the US Federal Trade Commission (FTC) on 26 November 2014. The company had earlier entered into an asset purchase agreement with Novartis Consumer Health Inc. to acquire the title and rights of Habitrol brand and to market the product in the US market.On 22 March 2015 Dr. Reddy's Laboratories (NYSE: RDY) announced that it had settled its claims against Nordion Inc. (formerly MDS Inc.) headquartered in Ottawa Canada in a case pending in the United States District Court for the District of New Jersey for a cash payment of USD 22.5 Million by Nordion to Dr. Reddy's. The case was brought by Dr. Reddy's in April 2009 seeking damages sustained by the company caused by a claimed breach by Nordion of its Laboratory Services Agreement with Dr. Reddy's. Nordion as a contract research organization provided laboratory services to Dr. Reddy's including bio-equivalency studies to support Dr. Reddy's regulatory applications for approval of generic drugs including Abbreviated New Drug Applications (ANDAs) filed with the United States Food and Drug Administration (the USFDA) for approval to market generic drugs in the United States. The case arose after the USFDA cited MDS with violations of good laboratory practices which caused the USFDA not to accept without further substantiation MDS's laboratory reports performed during the period 2000-2004. On 23 March 2015 Dr Reddy's Laboratories announced that it has entered into an agreement with Hetero under which Dr. Reddy's has been licensed to distribute and market Sofosbuvir 400 mg tablets indicated in the treatment of Chronic Hepatitis C under the brand name Resof in India. On 1 April 2015 Dr. Reddy's Laboratories announced that it has entered into a definitive agreement to acquire a select portfolio of the established products business of UCB a global biopharmaceutical company in the territories of India Nepal Sri Lanka and Maldives. The revenue of the acquired business stood at approximately Rs 150 crore for calendar year 2014.On 29 May 2015 Dr Reddy's Laboratories Limited and AstraZeneca Pharma India Limited entered into a distribution agreement for saxagliptin and its fixed dose combination with metformin in Type 2 DiabetesOn 6 August 2015 Dr. Reddy's Laboratories Ltd. announced that it has entered into a strategic collaboration with Amgen one of the world's leading independent biotechnology companies to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. On 16 September 2016 Dr. Reddy's announced that it had expanded its strategic collaboration with Amgen to market and distribute three of Amgen's medicines in India in the therapy areas of oncology and osteoporosis. On 9 September 2015 PanTheryx Inc. a global medical nutrition company based in Boulder Colorado and Dr. Reddy's Laboratories Ltd. announced a multi-country supply and licensing agreement whereby Dr. Reddy's Lab got the exclusive right to market and distribute PanTheryx's breakthrough nutritional intervention DiaResQ for infectious diarrhea in India and Nepal and in process for Russia Myanmar Vietnam Ukraine Sri Lanka Kazakhstan Belarus Jamaica and select LATAM markets. Dr. Reddy's will market the product in India and Nepal under the Reliqua brand.On 14 September 2015 Dr. Reddy's Laboratories announced the signing of a commercialization deal with Hatchtech an Australian pharmaceutical company developing an innovative prescription head lice product Xeglyze Lotion. The exclusive rights for this product are applicable for the territories of the United States Canada India Russia and the CIS Australia New Zealand and Venezuela. On 4 November 2015 Dr. Reddy's Laboratories entered into a strategic alliance with Biocodex a multinational pharmaceutical company to market and distribute Biocodex products in the Romanian market.On 5 November 2015 the US Food and Drug Administration (USFDA) issued a warning letter to Dr. Reddy's Laboratories relating to its API manufacturing facilities at Srikakulam Andhra Pradesh and Miryalaguda Telangana as well as Oncology Formulation manufacturing facility at Duvvada Visakhapatnam Andhra Pradesh. This action follows the earlier inspections of these sites by the agency in November 2014 January 2015 and February 2015 respectively.On 18 November 2015 Dr. Reddy's Laboratories announced that it had completed the purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium its generic anti-coagulant drug from its Australian partner Alchemia Limited. Earlier the company had signed a term sheet for this transaction in September 2015. Fondaparinux is a generic version of the anticoagulant drug Arixtra.On 11 March 2016 Dr. Reddy's Laboratories Ltd. and TR-Pharm announced a strategic collaboration agreement for the manufacture and commercialization of a portfolio of Dr. Reddy's Laboratories' biosimilar drugs in Turkey.On 28 March 2016 Dr. Reddy's Laboratories and XenoPort Inc. announced that they have entered into a license agreement pursuant to which Dr. Reddy's Laboratories will be granted exclusive US rights for the development and commercialization of XenoPort's clinical stage oral new chemical entity XP23829. Dr. Reddy's Laboratories plans to develop XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis and may potentially develop XP23829 for relapsing forms of multiple sclerosis (MS).On 31 March 2016 Dr. Reddy's Laboratories announced that it has entered into a licensing agreement with Eisai Co. Ltd Japan by which Dr. Reddy's will be granted exclusive worldwide development and commercialization rights (excluding Japan and Asia) for Eisai's investigational anticancer agent E7777. Eisai will be responsible for the development and marketing of E7777 in Japan and Asia while Dr. Reddy's holds the option for rights to develop and market the agent in India.On 25 May 2016 Dr. Reddy's Laboratories announced the acquisition of an eminent portfolio of over-the-counter (OTC) brands in the US in the cough-and-cold pain and dermatology categories from Ducere Pharma.On 3 August 2016 Dr. Reddy's Laboratories announced that it successfully completed the previously announced acquisition of a portfolio of complex generic products in the US from Teva Pharmaceutical Industries Ltd. and an affiliate of Allergan plc. On 11 June 2016 Dr. Reddy's Laboratories entered into a definitive agreement with Teva Pharmaceutical Industries Ltd. and an affiliate of Allergan plc to acquire a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the US for $350 million in cash.On 7 October 2016 Dr. Reddy's Laboratories announced its entry into Colombia with its portfolio of high quality and affordable medicines for Cancer patients.On 26 October 2016 Dr. Reddy's Laboratories announced that it had entered into a strategic collaboration with Gland Pharma a globally recognized developer and manufacturer of sterile dosage forms to market and distribute a diverse portfolio of eight injectable Abbreviated New Drug Applications (ANDAs) in the United States.On 8 February 2017 Dr. Reddy's Laboratories Ltd announced the expansion of its commercial operations in Europe with the introduction of its portfolio of generics in France. On 3 March 2017 Dr. Reddy's Laboratories announced that it had completed the acquisition of 100% stake in Imperial Credit Private Limited a Non-Banking Finance Company (NBFC) based out of Kolkata for a consideration of Rs 2.05 crore. The company proposes to undertake the group's captive financial activities through this entity.On 27 March 2017 Dr. Reddy's Laboratories and Integra LifeSciences Holdings Corporation a leading global medical technology company announced that they have entered into an exclusive distribution agreement. Under the agreement Dr. Reddy's will market and distribute DuraGen Plus and Suturable DuraGen Dural Regeneration Matrices for use in patients in India. The DuraGen product line offers Duraplasty Solutions meant for the repair of the dura mater. Dura mater is a thick membrane that surrounds the brain and spinal cord and contains the cerebrospinal fluid (CSF). DuraGen Plus Dural Regeneration Matrix is indicated as a dural substitute for the repair of dura mater. On 27 July 2017 Dr Reddy's Laboratories Ltd. and CHD Bioscience Inc. a privately-held biopharmaceutical company announced a global licensing agreement for the clinical development and commercialization of Dr. Reddy's phase III clinical trial candidate DFA-02. It is intended to be used for the prevention of surgical site infections following non-emergency elective colorectal surgery. Under the terms of the agreement Dr. Reddy's would receive equity in CHD valued at $30 million upon an IPO of CHD or a minimum of $30 million in cash within 18 months of execution of the agreement. Dr. Reddy's will also receive additional milestone payments of $40 million upon USFDA approval. In addition CHD will pay Dr. Reddy's double-digit royalties on sales and commercial milestones.On 22 August 2017 Dr. Reddy's Laboratories Ltd. through its wholly owned subsidiary Promius Pharma LLC announced that it has out-licensed the future development manufacturing and commercialization rights of DFD-06 a topical high potency steroid to Encore Dermatology Inc. The drug is intended to be used for treatment of moderate to severe plaque psoriasis. Under the terms of the agreement Encore will be responsible for the commercialization of DFD-06 in the United States. Promius Pharma is eligible to receive certain pre- and post- commercialization milestone payments of up to USD $32.5 million followed by fixed royalty payments on net sales.On 19 December 2017 Dr. Reddy's Laboratories Ltd. announced that its US subsidiary had reached a settlement with the US Government in a case involving packaging for five blister-packed prescription products. In a joint filing by the parties Dr. Reddy's and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law.