Top 10 stocks to buy in uncertain times

September 3, 2013

Top 10 stocks to buy in uncertain times

  1. L&T: The stock is trading at decade low valuation.
  2. HDFC Bank: Consistency will lead to premium valuation.
  3. Reliance Industries: Myopic market is ignoring long-term value.
  4. Coal India: High risk reward with low risk.
  5. M&M: Rural consumption will lead to re-rating.
  6. Ranbaxy: Top Pharma pick with target of Rs. 675.
  7. BPCL: Upstream investment value equals its entire stock price.
  8. Prestige Estates: Rental income to lead to 100 per cent upside in 3-year.
  9. Eicher Motors: Company well positioned for strong growth. Royal Enfield will cruise along for high growth.
  10. Gujarat Pipavav Port: Recovery in container volume will lead to growth.

 

Source : NDTV Profit


US bans import of 30 generic drugs of Ranbaxy

September 17, 2008

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

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.

Today’s announcement does not impact products from Ranbaxy’s otherplants which are not affected by today’s actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA’s drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

“With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research (CDER). “The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed.” The Warning Letters issued today document the results of FDA investigations at these two sites.

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.

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy’s responses, and the firm’s overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm’s responses. Ultimately, FDA concluded that the firm’s responses were not adequate and that the Warning Letters were the appropriate regulatory response.

“Today’s actions are clearly warranted by the serious violations established by FDA’s investigations at these two sites,” said Deborah M. Autor, director, CDER’s Office of Compliance, FDA. “Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products.”

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

The FDA will continue to work with Ranbaxy’s Dewas and Paonta Sahib plants to resolve these issues.
Consumers and health-care professionals can report adverse events to FDA’s MedWatch program at 1-800-FDA-1088; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or online, at the following Internet address: www.fda.gov/medwatch/report.htm

Source: FDA News


Daiichi Wins Approval to Buy Ranbaxy After Hurdles

August 6, 2008

Daiichi Sankyo Co., Japan’s third- largest drugmaker, won approval from the Indian government to buy Ranbaxy Laboratories Ltd. for as much as $4.7 billion after overcoming regulatory hurdles that delayed the takeover.

Daiichi Sankyo was cleared to acquire 34.8 percent of Ranbaxy from Chief Executive Officer Malvinder Singh and his family, said Yasuki Minobe, a spokesman for the Tokyo-based company. It will also offer to buy a further 20 percent from investors between Aug. 16 and Sept. 4, ICICI Securities Ltd., which is managing the tender, said in a statement.

The Japanese drugmaker agreed to the acquisition on June 11 to enter the generic-drug market, where sales are rising twice as fast as for branded medicines. Daiichi Sankyo said July 31 it was delaying the offer that had been scheduled to start Aug. 8.

Ranbaxy fell 1.9 percent to 512.65 rupees at 12:25 p.m. in Mumbai, reversing an earlier gain of as much as 3.8 percent. Daiichi gained 3.5 percent to 3,250 yen at the close in Tokyo.

The 737 rupee-a-share offer is still 41 percent more than Ranbaxy’s closing price yesterday. Daiichi Sankyo, which will also buy a portion of about $1 billion of preferential stock, will pay as much as 198 billion rupees ($4.7 billion), the company said in a presentation on June 12.

The Japanese drugmaker got approval from the Indian government yesterday to purchase shares of Ranbaxy and its unit Zenotech Laboratories Ltd., paving the way for the transaction process to proceed.

Ranbaxy agreed in October 2007 to buy 45 percent of Hyderabad-based Zenotech to gain access to the $65 billion market for biotechnology treatments. Daiichi plans to spend 850 million rupees to buy 20 percent of Zenotech from the public, as required by Indian takeover rules. The shares rose 1.3 percent to 113 rupees today.

To contact the reporters on this story: Saikat Chatterjee in New Delhi at schatterjee4@bloomberg.net.


Lawmakers Dredge FDA for Ranbaxy Inspection Documents

July 24, 2008

Two congressmen have launched an investigation into whether the FDA allowed drugs made by Ranbaxy to be sold in the U.S. despite knowing it had approved them based on fraudulent information and they were made in violation of good manufacturing practices.

Reps. John Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, sent a letter to FDA Commissioner Andrew von Eschenbach requesting information on each Ranbaxy drug the FDA has approved.

The letter comes roughly a week after India-based Ranbaxy defended itself against allegations in a Justice Department motion that it and consultant Parexel had withheld subpoenaed documents and thwarted an investigation over alleged fraud and conspiracy involving applications for generic drugs and distribution of AIDS therapies.

Justice, through the U.S. State Attorney’s Office for the District of Maryland and the Civil Division, Office of Consumer Litigation, maintains the company submitted false information about stability and bioequivalence to support ANDAs for anti-retrovirals distributed by the President’s Emergency Plan for AIDS Relief, a five-year, $15 billion program aimed at combating HIV and other diseases in 114 countries.

The government is probing whether Ranbaxy used active pharmaceutical ingredients (API) from unapproved sources, blended approved with unapproved API and put less API in drugs than approved by the FDA. It had subpoenaed certain documents, some of which the company refused to provide.

Ranbaxy subsequently said it would turn over all requested documents.

A copy of the letter is available at energycommerce.house.gov/Press_110/110-ltr.072208.FDA.Ranbaxy.pdf.


Ranbaxy claims big pharma company behind falsification accusations

July 17, 2008

Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company’s share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.

The Indian company was seeking to allay investors’ fears that the deal with Daiichi Sankyo, which is binding and final according to Ranbaxy, would be scuppered by the accusations.

In clarifying the situation Malvinder Singh, Ranbaxy’s CEO, said he believed that the falsification claims were orchestrated by a big pharma company acting in cahoots with elements in India.

Speaking to the media Singh said: “I understand that there are rumours in the market where a big pharmaceutical company and a multinational corporation, a leading Indian company and certain stock brokers out there are trying to create uncertainty, bring the price down and take advantage of the situation.

Daiichi Sankyo and Ranbaxy deal is absolutely on track and there are no changes. The deal of Daiichi Sankyo and Ranbaxy stands, it is a binding deal.”

Singh stopped short of naming any of the parties believed to be involved but did say that Ranbaxy is currently collecting data from the market with the intention of providing relevant information to the authorities in the future.
In doing so Ranbaxy has gone on the offensive after seeing its share price fall by 23 per cent over two days. As a result of Ranbaxy’s response its stock price rose by 15 per cent.

Ranbaxy’s stock price tumble followed the US Department of Justice filing documents with a district court in Maryland covering whether Ranbaxy had falsified data to achieve compliance with US regulations.

The FDA‘s filing is the latest twist in its three-year investigation into Ranbaxy’s operations, which has seen the agency raid the company’s US headquarters and New Brunswick manufacturing facility.

Ranbaxy’s statement played down the significance of the FDA’s latest move. Singh said: “This is a motion to seek information and there is nothing beyond that. Any information they need will be sent to them in the next few days.

Our technical consultants Parexel will provide the US authorities the requisite information in the next 2-3 weeks. It is our understanding with them that this motion will be recalled once we submit all documents.

Source: Outsourcing-Pharma


Ranbaxy probe includes AIDS relief meds

July 16, 2008

Ranbaxy can’t be happy. The Indian company’s stock is way down for the second day in a row, on news that the U.S. investigation into its operations includes allegations that it made weak or adulterated HIV drugs given to thousands of AIDS patients in Africa. The Indian company has U.S. government contracts to supply low-cost antiretrovirals for AIDS relief, but Justice Department and FDA investigators allege that some of those drugs were poorly made, unstable, or too weak to be effective.

Meanwhile, the company acceded to the government’s requests for documents, saying it would turn over the papers. The disputed documents are audit reports from Parexel, a consulting firm that examined Ranbaxy’s plants. You’ll recall that investigators claim at least some of these documents were fabricated to cover up the fact that Ranbaxy had made substandard products. The company had claimed that the audits were “privileged” and were thus confidential.

Ranbaxy also reiterated its conviction that its sale to Daiichi Sankyo remains on track and that its licensing deals–including a recent pact with Pfizer to produce an authorized generic version of Lipitor–aren’t affected by the probe, either. And the company says it “knows of no evidence to support” the U.S. allegations, which it acknowledged as “serious.”

Source: Wall Street Journal story