Ranbaxy shares fall on media report of FDA’s query about Mohali plant
Ranbaxy shares slipped as much as 2.3 per cent in early trade on Monday on media reports about the U. S. Food & Drug Administration's (FDA's) reported query about one of the company's manufacturing facility in northern India.
Citing anonymous sources, the Business Standard reported that the U. S. FDA had issued form 483 to Ranbaxy Laboratories Limited about its Mohali plant.
It may be noted here that form 483 is issued when FDA inspectors detect conditions they believe may breach U. S. rules & regulations.
When asked if the Ranbaxy had received the form 483 from the U. S. investigators, a spokesperson for the company declined to comment.
The spokesperson just said, "We continue to make regulatory submissions from Mohali and will commercialize products from Mohali when we get approvals."
The U. S. FDA, too, neither denied nor confirmed the report.
The reported issuing of the form 483 to Ranbaxy about its Mohali plant assumes significance as the Mohali unit forms an important part of the drug maker's strategy. After the blocking of the company's Paonta and Dewas facilities, it started facing capacity constraint at its US-based Ohm Laboratories. In late 2011, the company, thus, moved key products from Ohm to Mohali.