Ranbaxy to resume generic Lipitor production for U.S

Fri Feb 22, 2013 11:01pm IST

Related Topics

Stocks

   

REUTERS - Generic drugmaker Ranbaxy Laboratories Ltd (RANB.NS) said on Friday it will resume production of its version of Pfizer's (PFE.N) cholesterol fighter Lipitor for sale in the United States after resolving the issues that led to a November recall.

Ranbaxy in November recalled its atorvastatin from the U.S. market and stopped manufacturing the widely used cholesterol lowering medicine after the company discovered contamination with tiny glass particles in certain lots of 10 milligram, 20 mg and 40 mg doses of the drug. Atorvastatin is the generic name for Lipitor.

"We are working with the U.S. FDA, and have identified and implemented multiple corrective and preventative actions," Ranbaxy spokesman Chuck Capriello said in an e-mailed statement.

"As part of the first step in initiating the manufacturing process to resume supplies to the U.S. market, we have commenced the production of the drug substance for our atorvastatin product," he added.

The recall and production halt did not affect Ranbaxy's atorvastatin supply for markets outside the United States, the company said.

During its first six months on the market, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to industry analyst estimates.

Prior to expiration of Pfizer's patent, Lipitor was the world's top selling prescription medicine with annual peak sales of about $13 billion for the largest U.S. drugmaker.

Ranbaxy has been operating under heightened scrutiny to ensure it meets good manufacturing practices following a series of manufacturing problems that nearly derailed it ability to sell atorvastatin in the United States.

In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in its drug applications.

Ranbaxy said on Friday that it was confident in the continuing safety and quality of its products.

(Reporting by Bill Berkrot;editing by Sofina Mirza-Reid)

FILED UNDER:
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

  • Most Popular
  • Most Shared

FRESH RULES

A man speaks on his mobile phone in front of the Reserve Bank of India (RBI) seal at the RBI headquarters in Mumbai July 30, 2013. REUTERS/Vivek Prakash/Files

RBI says all companies must apply 2-step payments for credit cards

The Reserve Bank of India said that all transactions involving domestic credit cards must follow rules requiring additional verification, a stance that could impact companies such as Uber Technologies Inc that provide more simple app-based purchases.  Full Article 

REUTERS SHOWCASE

Record Highs

Record Highs

Nifty touches record high; software stocks gain.  Full Article 

New Adviser

New Adviser

Arvind Subramanian likely to be chief econ adviser.  Full Article 

Pricing Mechanism

Pricing Mechanism

Govt sets up a four-member panel to re-examine gas pricing.  Full Article 

Royalty Rates

Royalty Rates

India to hike iron ore royalty, miners may struggle to pass on extra cost.  Full Article 

Diesel Deregulation

Diesel Deregulation

Oil ministry to seek Cabinet nod on diesel deregulation - sources  Full Article 

Commodities

Commodities

Gold near two-month low; set for weekly drop on interest rate fears  Full Article 

Reuters Exclusive

Reuters Exclusive

Apple iPhone 6 screen snag leaves supply chain scrambling   Full Article 

Helping Regional Mills

Helping Regional Mills

Govt raises sugar import duty to 25 pct from 15 pct.  Full Article 

Curbing Risks

Curbing Risks

RBI to lower ceiling on bank loans to a single corporate group.  Full Article 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device.  Full Coverage