Ranbaxy taking 'stringent steps' to end US FDA ban

September 21, 2013 by Penelope Macrae

India's biggest drugmaker by sales, Ranbaxy Laboratories, has assured shareholders it is taking "stringent steps" to resolve a US ban on imports of medicines made at its newly renovated showcase plant.

The US Food and Drug Administration (FDA) banned imports last week from Ranbaxy's "ultra modern" Mohali plant, whose renovation was supposed to mark a turning point for the generics giant after years of run-ins with US regulators.

But now Mohali—along with two other Ranbaxy plants placed under FDA bans earlier—are unable to ship to the company's key US market due to for failing to meet "good manufacturing practices".

"Ranbaxy would like to assure all we are taking stringent steps to address all (the FDA's) concerns," Ranbaxy chief executive Arun Sawhney told shareholders in a letter posted late Saturday on the company's website.

Ranbaxy is more than 60 percent owned by Japan's Daiichi Sankyo, which bought the firm in 2008 believing its dominance in cheaper and developing markets would help the Japanese firm grow sales as Daiichi's drugs came off patent.

It outbid to buy Ranbaxy for $4.6 billion. But its foray into the high-growth copycat drugs arena has brought the Japanese drugmaker only financial pain as the Indian firm has come under fire over a string of safety problems.

New Delhi-based Ranbaxy's shares were trading Friday at 334 rupees—less than half the 737 rupees Daiichi paid in 2008.

The latest FDA ban came just four months after Ranbaxy pleaded guilty to US felony charges of selling adulterated antibiotic, and other drugs from the Dewas and Paonta Sahib plants—which are still unable to supply the US market—and paid a record $500 million fine.

The fraud involving the two Indian plants was exposed by an ex-employee who said the 52-year-old company had created "a complicated trail of falsified records and dangerous manufacturing practices".

Announcement of the ban on Mohali's US exports wiped nearly $1 billion off Ranbaxy's share value earlier in the week as a slew of brokerages downgraded the company's earnings prospects.

"We appreciate more is expected from Ranbaxy and will continue to work together with the FDA for an early resolution of their concerns", not only with Mohali but with the other two plants, Sawhney said.

The Mohali plant was gearing up to produce off-patent copies of two blockbuster drugs—Novartis AG's blood-pressure pill Diovan and AstraZeneca Plc's stomach ulcer medicine Nexium.

"The Mohali plant is crucial for (Ranbaxy's) future growth" and the ban "could be a huge setback for the company," said Sarabjit Kour Nangra, a vice-president of Mumbai's Angel Broking.

FDA inspectors found tablets with a "black fibre" suspected to be human hair and pills with apparent machinery oil "black spots" at the Mohali plant. Last year, glass was detected in some pills made at the plant.

A spokesman for Ranbaxy declined Saturday to comment on media reports that the FDA now was scrutinising Ranbaxy's US-based Ohm Laboratories for potentially breaching the US Food, Drug and Cosmetic Act.

Ohm Laboratories is Ranbaxy's only facility making medicines for the US market, even though the company has a total of eight plant sites in India.

The US has traditionally accounted for some 40 percent of Ranbaxy's revenues.

Explore further: India's Ranbaxy promises to address issues over US ban

Related Stories

India's Ranbaxy promises to address issues over US ban

September 17, 2013
India's Ranbaxy Laboratories, one of world's biggest generic drug makers, said Tuesday it would take "all necessary steps" to help lift an import ban by the US health regulator on one of its factories.

Indian drugmaker Ranbaxy faces new US regulation woes (Update 2)

September 16, 2013
Shares in Indian generic drugs giant Ranbaxy Laboratories crashed by as much as 35 percent on Monday after the US Food and Drug Administration suspended imports from one of its factories.

More pain for Japan's Daiichi hit by Ranbaxy fraud

June 9, 2013
Daiichi Sankyo believed it had scored a coup in 2008 when it outbid rivals to buy Indian generics giant Ranbaxy for $4.6 billion but its foray into the high-growth copycat drugs arena has brought the Japanese drugmaker only ...

Ranbaxy recalls generic Lipitor doses

November 23, 2012
(AP)—Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once ...

India says its drugs safe after generics fraud

June 3, 2013
India, known as the "pharmacy to the world", Monday defended its lucrative generic drug industry as safe and strongly regulated after the nation's biggest drug firm pleaded guilty to US charges of making adulterated medicines.

Ranbaxy CEO planning expansion in US, elsewhere

July 10, 2012
(AP) — The head of Indian drugmaker Ranbaxy Laboratories Ltd. says he's charging ahead with plans to expand sales in the crucial U.S. market, despite extra oversight from American regulators over quality questions that ...

Recommended for you

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

New study generates more accurate estimates of state opioid and heroin fatalities

August 7, 2017
Although opioid and heroin deaths have been rising dramatically in the U.S., the magnitude of the epidemic varies from state to state, as does the relative proportion of opioid vs heroin poisonings. Further complicating the ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.