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Last Updated : Nov 01, 2016 09:53 AM IST | Source: CNBC-TV18

Drug co Caplin Point eyes US foray by 2018-end

Caplin Point Laboratories should be able to foray into the US market by end of 2018, says Chief Promoter and Chairman CC Paarthipan in an interview to CNBC-TV18.


Caplin Point Laboratories should be able to foray into the US market by end of 2018, says Chief Promoter and Chairman CC Paarthipan in an interview to CNBC-TV18.


Caplin, which is an export-oriented company with nearly 90 percent sales to Latin America as of now, is awaiting an Establishment Inspection Report (EIR) by the US Food and Drug Administration (FDA) for its injectable facility.

So far only two technical observations have been issued by USFDA, Paarthipan says, adding, one of them pertains to quality control.

Below is the verbatim transcript of Cc Paarthipan’s interview to Anuj Singhal & Sonia Shenoy on CNBC-TV18.

Anuj: If you could tell us what does this mean, does this mean you can now enter US in a big way and what are your plans for the US market?

A: This one is actually for the site inspection. We just completed the site inspection with two observations. We are neither in the form of data integrity nor any significant good manufacturing practice (GMP) violation. This will open up the site transfer opportunities as you are aware that some facilities have already received with warning letters and import alert, they are under remediation that is one thing. In addition to that we are developing five dossiers of our own and another four with actually partners. The product will take another one – one and a half year. Hopefully, by end of 2018 we will be in the US market.

Sonia: By end of 2018 you will be in the US market so how much do you expect to see in terms of revenues from the US markets and as the contributions to our overall sales, over the next couple of years how much do you think it could be?

A: The revenue volume will not be able to predict at this juncture, but again as you know well the market is very lucrative. The most important market for any pharmaceutical industry is US and the goal standard for any company is to get the USFDA approval to start with. First level is completed; we are just waiting for the facility approval and the products we have already developed. Some are in the form of simple and some are actually complex molecules. Value-wise and volume-wise it will high that is what I could say at this moment.

Anuj: If you could tell us the nature of the two USFDA observations, they are not data integrity, is that something that you are telling us?

A: Neither data integrity nor significant GMP violation. We believe it is very minor in nature. It is related to our raw data and other laboratories. One more is the laboratory issue, QC issue.

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First Published on Nov 1, 2016 09:11 am
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