Receiving Form 483 from US Food and Drugs Administration (USFDA) for its Toansa plant in Punjab will add pressure on Ranbaxy. Ranbaxy has been hammered out of shape since the time its major facilities came under USFDA scanner, say Sarabjit Nangra, Angel Broking.
Ranbaxy has said that it is assessing the observations and will respond to the USFDA at the earliest. This matter is critical for Ranbaxy since 70-75 percent of the company’s manufactured active pharmaceutical ingredients (APIs) are from there.
Below is the verbatim transcript of his interview on CNBC-TV18
Q: Your reaction on the fact that Toansa at Punjab has also received a 483 observation from the US FDA. How grave would it be?
A: As it is most of the manufacturing facilities of the company are under US FDA now. One more coming in is obviously not a good deal. So, it is bad news for Ranbaxy again and I guess it will take long time for Ranbaxy to come out of this whole issue than expected.
Q: What would be the percentage of revenues or the contribution of the Toansa unit with respect to the products and if things get worse what will be the potential financial impact?
A: It is difficult to assess the exact percentage revenue from a particular plant for any pharma company. The company too has not come out as of now with any statement. Its major facility Paonta Sahib and other facilities are already under scanner and those were much bigger in terms of future potential and in terms of company auguring well. So, this shouldn’t be that grave but since it is in the same scheme of things rather than things improving, it is adding to the problems.
From that perspective, it is negative otherwise I don’t think it should be such a great dampener. The damage has already happened to Ranbaxy.
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