Ranbaxy Labs gets approval for Esomeorazole Magnesium capsules

Ranbaxy Laboratories Ltd on February 07, 2008 has announced that the Company has received tentative approval from the U.S. Food and Drug Administration for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (base) and 40 mg (base). Nexium® (Esomeprazole) is the second largest selling drug in USA with total annual market sales of $5.5 billion (IMS — MAT: December 2007).

Ranbaxy believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future.

Esomeprazole is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis, to maintain symptom resolution and healing of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease (GERD),.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Nexium® is the registered trademark of Astra Zeneca.

Ranbaxy - settlement of Imitrex with Glaxo

Ranbaxy Laboratories Ltd on January 21, 2008 announced that the Company has settled all matters relating to possible patent litigation with GlaxoSmithKline relating to Sumatriptan Succinate Tablets, the generic version of GlaxoSmithKline's Imitrex® Tablets.

The terms of the settlement, provide that Ranbaxy may distribute a generic version of
Sumatriptan Succinate Tablets (in the 25 mg, 50 mg and 100 mg strengths) in the United
States with an expected launch date in December, 2008.

Additional terms of the settlement agreement were not disclosed.

The annual market sales for Sumatriptan Succinate (Imitrex®) were USD 985 million (IMS- MAT: Sept 2007).

Ranbaxy Laboratories receives final approval to manufacture and market Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10mg

Ranbaxy Laboratories Ltd on December 31, 2007 has announced that the Company has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Zyrtec® Allergy tablets, 5mg and 10mg and Zyrtec® Hives Relief tablets, 5mg and 10mg by Pfizer Pharmaceuticals Inc. Total annual market sales for Cetirizine Hydrochloride Tablets as a prescription only product were $1.3 billion (IMS - MAT: September 2007).

Cetirizine Hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

"We are pleased to receive this final approval for Cetirizine Hydrochloride Tablets (OTC) 5mg and 10mg, that has proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions. This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, Vice President of Sales and Distribution for Ohm Laboratories Inc, a wholly owned subsidiary of the Company.

Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of the Company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the U.S. healthcare system.

Ranbaxy reaches agreement with Astellas

Ranbaxy Laboratories Ltd on November 08, 2007 has announced that the Company has reached an agreement with Astellas / Boehringer Ingelheim to stipulate a remand of the pending Federal Circuit appeal and subsequent vacatur of the District Court decision in regards to Flomax® (Tamsulosin capsules). The case between the Company and Astellas / Boehringer Ingelheim has been dismissed without prejudice. The lawsuit in the U.S. was related to Astellas' U.S. Patent No. 4,703,063 ('063 patent), covering Tamsulosin and its use in the treatment for functional symptoms of BPH (benign prostatie hyperplasia).

Under the agreement, the Company will enter the U.S. market on March 02, 2010, eight weeks prior to expiration of the pediatric exclusivity, which is likely to be granted to the innovator Company. During this time period of pediatric exclusivity, the Company will be the only generic manufacturer to commercialize this product in the U.S. market. The Company believes that its Tamsulosin ANDA is the first substantially complete ANDA with a Paragraph IV certification to the '063 patent. The total annual sales of Flomax are estimated to be USD 1.2 Bn (source IMS).

On June 20, 2007, the Company received tentative approval from the U.S. FDA in regards to its Tamsulosin ANDA No. 77-451.

The Company will continue to pursue a strategy to effectively optimize its pipeline of First-to File (FTF) opportunities. The Company believes that it has a FTF status on approximately 17 Paragraph IV ANDA filings representing a market size of ~ USD 26 Bn valued at innovator prices.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy USFDA approval for Valsartan Tablets

Ranbaxy Laboratories Ltd on October 29, 2007 has announced that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valsartan Tablets, 40 mg, 80 mg, 160 mg and 320 mg. Total annual market sales for Valsartan Tablets were $1.3 billion (IMS MAT June 2007).

Valsartan is indicated for the treatment of hypertension alone or in combination with other anti-hypertensive agents. Valsartan is also indicated for the treatment of heart failure (NYHA class II -IV).

"We are pleased to receive tentative approval for Valsartan Tablets. We believe, we are first to file a substantially complete ANDA and will stand to gain from the 180 day exclusively available to the first filer. These product formulations have been developed organically within Ranbaxy and will further expand our product portfolio of affordable generic alternatives," said Jim Meehan, Vice President of Sales and Distribution for RPL.

Ranbaxy Pharmaceuticals Inc (RH) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL), India's largest pharmaceutical Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy launches Osonase nasal spray in India

Ranbaxy Laboratories Ltd on October 24, 2007 announced the launch of its branded Novel once-a-day product, Osonase (Ciclesonide) aqueous nasal spray in India. The product introduced as a Nasal Spray, will be used for the treatment of seasonal and perennial allergic rhinitis in adults and adolescents.

Osonase is available as a 50mcg (per dose/actuation), 120 metered doses, aqueous nasal spray.

Commenting on the launch, Sanjeev I Dani, Senior Vice President & Regional Director, Asia & CIS, Ranbaxy, said, "The launch of Osonase underpins our commitment to provide contemporary patient friendly solutions for the effective management of respiratory disorders like seasonal and perennial allergic rhinitis. Today Ranbaxy offers a wide range of innovative products in the asthma segment with novel delivery mechanisms such as DPIs (Dry Powder Inhalers) and pMDIs that are HFA (Hydro Fluoro Alkanes- environment friendly propellant) technology based inhalers, and Nasal Sprays to suit the convenience of patients."

Allergic rhinitis represents a global health problem and is believed to be a precursor for Asthma. It is a common disease worldwide affecting at least 10-25% of the population and its prevalence is increasing. Moreover it alters the social life of the patients and affects school performance and work productivity and therefore the cost implications are substantial.

In 2005, Ranbaxy entered the Asthma segment and in a short span of two years the Company has expanded itself in this segment with a range of inhalers. Ranbaxy has the distinction of being the first Company to introduce Osonide (Ciclesonide) Inhaler, a novel once-a-day product (for the treatment for Asthma). Later in September, 2006 Ranbaxy launched Avessa (Formoterol + Fluticasone) inhalation capsules in India and in November 2006 launched for the fist time in the world Avessa HFA inhaler. In March this year, Ranbaxy launched Osovair (Formoterol + Ciclesonide) inhalation capsules in India, yet another unique combination introduced for the first time in the world.

Both Avessa and Osovair inhalation capsules are to used with Rheohaler, which is the worlds' first multi-dose capsules based novel DPI delivery system

Ranbaxy Laboratories Ltd

Rabo India Securities Pvt Ltd ("Manager to the Offer"), on behalf of Ranbaxy Laboratories Ltd ("Acquirer"), has issued this Public Announcement ("PA") to the Shareholders of Zenotech Laboratories Ltd ("Target Company"), pursuant to and in compliance with, among others, Regulation 10 & Regulation 12 of the Securities & Exchange Board of India (Substantial Acquisition of Shares & Takeovers) Regulations, 1997 and subsequent amendments thereto (the "Regulations" or the "SEBI Takeover Code").

The Offer

The Acquirer proposes to acquire from the existing non-promoter shareholders of the Target Company upto 68,93,000 fully paid-up equity shares of the Target Company (the "Offer Size") representing 20% of the Expanded Equity Capital at a price of Rs 160/- for each fully paid-up equity share of the Target Company ("Share") (such price , the "Offer Price"), to be paid in cash in accordance with the Regulations.

Schedule of Activities:

Specified Date - October 26, 2007

Date of Opening of the Offer - November 19, 2007

Date of Closing of the Offer - December 08, 2007

Ranbaxy Laboratories

Ranbaxy Laboratories Ltd has announced that on October 04, 2007 the Company has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Clarithromycin for Oral Suspension, USP, 125 mg/5 mL and 250 mg/5 mL. The Company is the first Company to have been granted a generic approval for the Oral Suspension form along with Clarithromycin Tablets. Total annual market sales for Clarithromycin were $99.7 million with suspension sales totaling $25.3 million(IMS MAT: June 2007).

"We are pleased to receive this FDA approval for Clarithromycin for Oral Suspension, an anti-infective agent that will add depth and breadth to our product line of anti-infectives that also includes Clarithromycin tablets. RPI will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place. This approval further expands our product portfolio of affordable generic alternatives and will he shipped immediately to all classes of trade," according to Jim Meehan, Vice President of Sales and Distribution for Ranbaxy Pharmaceuticals Inc. (RPI).

The Office of Generic Drugs, U.S. FDA, determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Biaxin® Granules (Clarithromycin for Oral Suspension, USP), 125 mg/5 mL and 250 mg/5 mL of Abbott Laboratories.

Clarithromycin for oral suspension, USP, is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in a number of conditions including: Pharyngitis / Tonsillitis, Community-Acquired Pneumonia, uncomplicated skin and skin structure infections and disseminated mycobacterial infections.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

Ranbaxy Laboratories

Ranbaxy Laboratories Ltd has informed that the Company and Zenotech Laboratories Ltd (Zenotech) on October 03, 2007 has announced the signing of Definitive Agreements, providing for an increase in equity stake by Ranbaxy from its current 7% to 45% at a price of Rs 160 per share aggregating to Rs 214 Crores. This involves:

(a) Purchase of shares from the existing Promoters
(b) Preferential Offer to Ranbaxy by Zenotech

The above triggers a mandatory open offer by Ranbaxy to other shareholders of Zenotech, at a price of Rs 160 per share or as determined by SEBI regulations.

Post the offer, the existing Promoter Group of Zenotech will have a 25% stake in its expanded equity capital. Dr. Jayaram Chigurupati shall continue as the Managing Director.

Speaking on the development, Mr. Malvinder Mohan Singh, CEO & MD, Ranbaxy, said, "The increasing importance of Biologics in the Global Pharmaceutical industry and the opening up of the generic Biologics in the regulated markets, makes it opportune for Ranbaxy to enhance its presence in this area. Specialty injectables, that include Oncology products, constitute an attractive segment that underpins our strategic intent. Having worked with Zenotech for almost two years, we believe that this investment and partnership provides a strong platform for us to leverage these opportunities."

Zenotech has received three Indian approvals for Oncology Biopharmaceuticals i.e. GCSF (Granulocyte Colony Stimulating Factor), GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) and IL-2 (interleukin-2). For the latter two, Zenotech is the first to receive approvals in India, and has a pipeline of further seven Biopharmaceutical products in different stages, all developed in-house. It has state-of-the-art manufacturing facilities in Hyderabad, India, while its R&D facilities are in Hyderabad and New Jersey, USA.

Presently, the Global Biopharmaceutical market is valued at app. USD 65 Bn at innovator prices and Zenotech's pipeline addresses a third of this market. The Global Oncology market is worth over USD 35 Bn and is considered among the fastest growing therapeutic segments globally. Specialty Injectables are a high value addition segment, compared with orals and Ranbaxy plans to file seven US ANDAs from Zenotech facilities in the coming few months.

Ranbaxy Laboratories

Ranbaxy Laboratories Ltd on September 24, 2007 announced that the Company has signed an exclusive in-licensing agreement with Sirtex Medical Pvt Ltd (Sirtex), Australia, to promote and market Sirtex's product, SIR-Spheres®. The product, approved by the US Food and Drug Authority, is used for the treatment of patients with inoperable tumors from primary colorectal cancer that have spread to the liver (Unresectable Metastatic Liver Tumors from Primary Colorectal Cancer).

Commenting on the licensing deal, Mr. Sanjeev Dani, Senior Vice President & Regional Director, Asia & CIS, of the Company, said, "We are pleased to partner with Sirtex, Australia, for this unique, high technology product -SIR Spheres®. We shall work towards creating a productive relationship by complementing each others strengths. The agreement will enable Ranbaxy to further strengthen our position in Oncology Segment"

SIR-Spheres® are biocompatible radio-active micro-spheres that contain yttrium-90 and emit bcta radiation. They are implanted using a syringe and travel via the blood stream, whereupon the spheres are targeted to the tumors within the liver. Once targeted to the tumor, SIR-Spheres irradiate it by a process known as Selective Internal Radiation Therapy (SIRT), leading to the destructs ion of the tumor, whilst most of the normal liver tissue remains relatively unaffected.

SIR-Spheres have been used to treat many hundreds of patients with liver cancer in Australia, USA, Europe, New Zealand and Asia in a variety of clinical trials and general practice.

Hepato-Cellular Cancer (HCC) is fifth most common cancer in the world and fourth leading cause of cancer deaths in the world. Though HCC was rare in Western World and common in Asian Pacific region, there, is worldwide increasing incidence of HCC. In India also there is increasing incidence of HCC. According to 2001 estimates in India, about 12,750 new patients were diagnosed to have HCC. In India, prevalence of HCC is about 5 patients per 100,000 population and men are affected twice as often as women. The incidence is 2.77 males and 1.28 females per 100,000 people. The mean age at diagnosis is between 50-60 years.

Colorectal Cancer (CRC) is one of the most common cancers in the Western Society. The incidence of CRC is rising in India both amongst men and women. Currently the prevalence is close to 4 cases per 100,000 population. For the year 2001, it was estimated that the incidence of colorectal cancer in India would he 18,427 in men and 13,092 in women. This is similar to the number diagnosed annually in the UK. More than 90% of CRC cancer occurs in patients older than 50 years. Obesity, tobacco use, dietary factors, inflammatory bowel disease are sonic of the risk factors associated with CRC.

SIRTeX Medical's principal activities include research, development and commercialization of treatments for liver cancer. The Company was formed in 1997 to acquire and commercialize a portfolio of three technologies relating to the treatment of liver cancer developed by the CRI and Dr Bruce Gray. SIRTeX Medical aims to become the world leader in liver cancer treatment products. The Company believes the unmet demand for effective treatment of liver cancer provides an opportunity for SIRTeX Medical's products, and it will also apply its micro-sphere technology to other diseases where the Company's intellectual property can provide market opportunities.

Ranbaxy Laboratories Ltd

Ranbaxy Laboratories Ltd has informed the Exchange regarding a press release dated September 06, 2007, titled "Ranbaxy Gains US FDA Approval to Manufacture and Market Carvedilol Tablets in the US Market; A Blockbuster Brand that will be Commercialized as an Affordable Generic".