RANABAXY HAVE A FULL VIEW BUY NOW CMP FOR SHORT & LONG TERM GUD INVESTMENT

RANBAXY A VALUE BUYYING @240-250
Important Facts about FDA ban on Ranbaxy 30 Drugs.
Excerpts from the following link: http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm
The U.S. Food and Drug Administration has issued two Warning Letters to Ranbaxy Laboratories, Ltd., an India-based manufacturer of generic drugs, some for the U.S. market. The Warning Letters address the manufacturing conditions at two different Ranbaxy plants in India, Dewas and Paonta Sahib.
Ranbaxy manufactures many drugs, and only a portion of them are made at these two plants located in Dewas and Paonta Sahib, India. At these two facilities, Ranbaxy manufactures more than 30 different generic drugs (in multiple dosage forms), such as antibiotics, anti-virals, and others, for the U.S. market.
Ranbaxy is the sole supplier to the United States of, Ganciclovir oral capsules, an anti-viral drug. FDA is generally not preventing the importation of this product to minimize any disruption to the market.
To date, FDA has no evidence of harm to any patients who have taken drugs made in these two facilities.
Additionally, consumers should know that products from Ranbaxy’s other plants are not affected by this action. FDA has inspected those facilities and to date they have met FDA standards for drug manufacturing.
Press Release from FDA.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html
The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.
The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health.
One Warning Letter addressed problems at Ranbaxy's dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm's quality control program:
The facility's beta-lactam containment program (measures taken to control cross contamination),which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
Inadequate batch production and control records;
Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
Inadequate aseptic (sterile) processing operations.
The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit; also in early 2008.This inspection documented various cGMP deficiencies, including the following:
The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;

Inaccurate written records of the cleaning and use of major equipment;

Incomplete batch production and control records; and,

Inadequate procedures for the review and approval of production and control records for drug products.

27% of total sales from North America, Which includes Canada as well.
Last year, sales of generic drugs in the U.S. accounted for 23 percent of Ranbaxy's total revenues. http://www.ranbaxyusa.com/
Ranbaxy has plants in 11 countries, including three in the U.S. Sales of medicines and pharmaceutical ingredients from those sites are unaffected.
Ranbaxy's plants in New Jersey and New York make 59 drugs for U.S. consumers, including: Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.
We estimate that these could account for up to 30% of Ranbaxy’s current non-specialty sales in the US.

239* ANDAs approved by US FDA 93 pending approvals (As of June 30, 2008)* these numbers do not include PEPFAR applications
Drugs List
A List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. (Revised September 24, 2008)
http://www.fda.gov/cder/drug/infopage/ranbaxy/ranbaxy_list.htm click here.


Daiichi holding
http://www.atimes.com/atimes/South_Asia/JF19Df02.html
The takeover valued Ranbaxy, which will become a Daiichi subsidiary, at over $8.4 billion, while making the Japanese company the world's fifteenth-largest drug maker from its current rating of 22. Daiichi will raise its Ranbaxy holding to a minimum of 54.8% through an open offer to shareholders at 737 rupees (US$17) per share.

Why the Indian government is lobbying with the US for Ranbaxy?
http://www.businessworld.in/index.php/Pharma/Entry-Denied.html
After the US Food & Drug Administration (FDA) banned the entry of 30 drugs of Ranbaxy into the US citing violations in manufacturing and quality control regulations, the Indian government is reportedly willing to lobby the US on the drug maker’s behalf.
“Ranbaxy has informed us that those violations have been corrected, and it would now invite the FDA to come and inspect its facilities,” an official from the Ministry of Commerce was recently quoted as saying in a newspaper. If the FDA refused to lift its so-called ‘import alert’, the government would “discuss the matter with the US” as a “non-tariff barrier”, the official said.
Why is the Indian government carrying a brief for Ranbaxy? The FDA has clarified that Ranbaxy’s drugs are still fit for consumption and that the violations involved processes and documentation. It continues to approve drugs from other Indian firms. Moreover, is the Indian government in a position to cross swords with the FDA? India is collaborating with the FDA for training its own staff on regulatory issues, and standard setting for evaluating drug manufacturers. Ironically, this cooperation has been hailed by a section of India’s drug industry as a way to contain doubts cast on the quality and safety of Indian medicines.

Latest Update
http://www.bloomberg.com/
U.S. Offers to Withdraw Motion against Ranbaxy after Review
By Saikat Chatterjee Oct. 2 (Bloomberg) -- The U.S. government offered to withdraw a motion seeking to force Ranbaxy Laboratories Ltd. of India to turn over audit reports and other documents if the almost 500,000 pages submitted last week are found to be complete.
The government asked to have until Oct. 6 to review the materials from India's largest drug maker, according to a court filing to the U.S. district Court of Maryland, Southern Division.
``Upon confirmation that the production is complete, or if not, that a supplemental production will be forthcoming, the government will withdraw the motion,'' the filing said.
The motion will be reopened if the government decides that Ranbaxy improperly withheld any ``responsive, non-privileged documents,'' the government said in the filing.
The U.S. is probing whether Ranbaxy, based in Gurgaon, near New Delhi, destroyed reports it was required to keep, falsified data and failed to meet quality-control specifications in manufacturing the generic drugs it sells. The Indian company has denied the allegations and agreed to produce all the documents.
Separately, the U.S. drug regulator on Sept. 16 blocked the sale of more than 30 generic medicines made in two factories by Ranbaxy, because of deficiencies in manufacturing processes. The U.S. Food & Drug Administration said there was no evidence that Ranbaxy's drugs were harmful.
Our view Ranbaxy BETWEEN 240-250 As an Investment, one can buy this stock with a price tgt of 500-600 in 18-24 months.Even in short term of 6-8 weeks, we can see a price tgt of 300-320 around. At a price of 737 Daiichi has bought this stock and we are getting this @ discount of 66% from Daiichi. CMP is 251 around and is a value buy.

Excerpts have been taken from the following links:
http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm
http://www.ranbaxy.com/
http://www.ranbaxyusa.com/
http://www.atimes.com/atimes/South_Asia/JF19Df02.html
http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biotech/US_likely_to_withdraw_motion_against_Ranbaxy/articleshow/3551483.cms
http://www.businessworld.in/index.php/Pharma/Entry-Denied.html
http://www.bloomberg.com/
http://www.economictimes.com/