Granules India gets US FDA approval for orange-coloured 200 mg version of ibuprofen.
Have a major share in the ibuprofen formulation market, says C Krishna Prasad, MD of Granules India.
Orange ibuprofen will help strengthen US portfolio, he said.
Speaking to CNBC-TV18, he said market for orange-coloured tablet is around USD 49 million.
However, orange is just a colour variation, he added.Below is the verbatim transcript of C Krishna Prasad's interview to Ekta Batra & Prashant Nair.
Ekta: We understand that you are the largest active pharmaceutical ingredients (API) manufacturer of ibuprofen in the US but in terms of this US FDA approval for its abbreviated new drug application (ANDA) or for the final product or the drug, how much would it mean in terms of incremental sales for you?
A: We are not the largest API manufacturer in the US but we have a major share of the formulation business especially the Rx ibuprofen, we have a major share and we are building up the share.
However, coming back to orange; orange is an addition to our existing portfolio in the over the counter (OTC) private label segment. We already have brown and brown is doing well and orange will add and strengthen our portfolio. However, customers who want brown tablets, they also need orange and having orange will definitely increase our brown sales.
Coming to orange incremental sales, the market for orange is about USD 49 million in the private label sector and we expect that over few years we can get about 5-10 percent of the market but it will definitely help us in increasing sales of brown ibuprofen.
Ekta: How would that help? Could you take us through the key difference between brown and orange? Is it just a colour variation or is it just an add-on dose. Could you just take us through why brown sales would go up if you have got the approval for orange?
A: It is a colour variation. The efficacy everything else is the same. The Motrin brand is orange and ibuprofen brand is brown. So, people will sell these products saying similar to Advil, similar to Motrin like in the private sector, for example Wal-Mart, they brand it on their names and people who are buying some tablets from us, they want the entire basket. If they want ibuprofen, they need both these things and so we had a problem in the past that people asking for orange didn't have it. However, now with this approval we expect our brown sales also will go up and on orange about 5-10 percent is what we expect over few years.
Ekta: What about further US FDA approvals for other formulations that you have in your portfolio besides ibuprofen?
A: We have already filed a few and from our US facility we will be filing two and from India we have already filed three. We will be filing three more in this year and all together we will have eight filings this year.
Ekta: Could you update us with regards to the domestic markets as well. What kind of market share would you have there?
A: We do not sell formulation in the domestic market. We only sell APIs in the domestic market.
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