Ranbaxy Scrambles for Ingredients to Make Generic Nexium - The New Indian Express

Ranbaxy Scrambles for Ingredients to Make Generic Nexium

Published: 11th March 2014 04:49 PM

Last Updated: 11th March 2014 04:49 PM

* Ranbaxy faces delays, high costs due to in-house problems

* Indian firm's pain may be AstraZeneca's gain

Indian drugmaker Ranbaxy Laboratories Ltd is in talks with at least two companies on sourcing ingredients for a generic version of AstraZeneca Plc's heartburn drug Nexium, a source said, to ensure the pills can be sold in the United States.

The United States banned shipments from one of Ranbaxy's plants in India following an inspection that found poor manufacturing practices, effectively barring India's top drugmaker by revenue from selling drugs in the United States from its India plants.

Ranbaxy's Ohm Laboratories plant in New Jersey is now the only facility that makes generics for the United States.

Any delay in launch of generic Nexium, AstraZeneca's second-biggest seller, will have a big impact on the British company's profit. Nexium had global sales last year of $3.87 billion and U.S. sales of $2.12 billion.

Retaining exclusivity on Nexium in the all-important United States beyond the end of May would not only limit a forecast decline in AstraZeneca's 2014 earnings but could also protect bonuses for top management at the British company.

Ranbaxy's talks with ingredient makers are part of a scramble to ensure it can still be the first to sell a cheaper copy of Nexium in the United States after the drug's patent term ends on May 27, despite regulatory sanctions for production quality.

The source, who has direct knowledge of the matter, declined to give details and refused to be named due to the sensitivity of the issue.

A Ranbaxy spokesman said the company has no comment for now.

Doubts about the ability of India's top drugmaker by revenue to launch the drug grew after the FDA in January prohibited it from shipping to the United States any pharmaceutical ingredient made at its Toansa plant in northern India.

comments powered by Disqus

Disclaimer: We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the NIE editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

Read More

follow us Mobile Site iPad News Hunt Android RSS Tumblr Linekin Pinterest Youtube Google Plus Twitter Facebook