|
| Ranbaxy expects reply on Paonta Sahib this month |
| Press Trust of India / New Delhi Jul 24, 2009, 20:51 IST |
|
Domestic drug maker Ranbaxy Laboratories is expecting a reply by the end of this month on the corrective action plan submitted by it to the US health regulator in May this year for its Paonta Sahib (Himachal Pradesh) facility.
"We are expecting a reply from the US FDA in July," Ranbaxy CEO Atul Sobti told reporters here.
Last year, the US health regulator Food and Drug Administration (FDA) had banned import of 30 drugs made by the Gurgaon-based company in its Paonta Sahib and Dewas (Madhya Pradesh) plants alleging violation of good manufacturing practices.
Later, FDA imposed 'AIP' against these two facilities, as per which the company is not permitted to submit drug applications from these plants.
In May, Ranbaxy along with a team of experts from its Japanese parent company Daiichi Sankyo has submitted a corrective action plan to FDA and senior officials of the company had met FDA officials last month to discuss the issue.
The communication assumes significance as most of the company's filing to the US for drug approvals were for medicines made in the Poanta Sahib plant.
However, Ranbaxy has shifted manufacturing of some of its medicines from these units to its US arm Ohm Laboratories, Sobti said, adding, the company has already submitted its reply to FDA for Dewas facility and is waiting for re-inspection of the Madhya Pradesh plant.
The company expects restrictions on the Paonta Sahib plant to be lifted before the Dewas plant, Sobti said.
About future plans, Sobti said the company is in talks with Daiichi Sankyo to introduce some of innovative products from Japanese company's portfolio in India and other emerging markets.
When asked about details of products, he declined to divulge any thing but said, "We are hoping for atleast top five products from their portfolio."
|
|
|
|
|
|
|
|
|
|
 Read Business news in |  |
|
|
|
|
|
|
Advertisements |
|
|
|
|
|
|
|
|
|
|
Content Guide
