Planning capex of Rs 300 cr at Guwahati plant: Ajanta Pharma

On the sidelines of the Antique Investor Conference, Yogesh Agrawal, MD of Ajanta Pharma told CNBC-TV18 that the company has filed for 5 Abbreviated New Drug Application’s (ANDA) of which 2 tentative approvals may be launched in the near future.

Ajanta plans to file 10 ANDA’s every year and is planning a capex of Rs 300 crore at its Guwahati facility, he added.Below is the transcript of Yogesh Agrawal’s interview with Ekta Batra on CNBC-TV18. Q: What are your future plans in India? A: In India, our focus is on the three speciality segment, we are in ophthalmology, we are the fifth largest player. We are in cardiology and dermatology. So, all these three sectors we have seen a decent growth. Overall the pharmaceutical market is growing at 13 percent and we are also growing higher than the market. So, we are optimistic to continue this momentum going forward. Q: You received a couple of US Food and Drug Administration (FDA) tentative approvals and you have around 18-19 Abbreviated New Drug Applications (ANDA) pending in the US. What is your plan with the US? How much do you plan to scale it up by? A: As we speak, we have launched five ANDAs out of which three we have received very recently. We have two tentative approvals which we will be launching as they off patent moving forward. And we have about 18 ANDAs which are awaiting approval. Our target is to file more than 10 ANDAs every year and we are looking to file the products where there is a limited competition kind of scenario which are more complex and extended release, delayed release, controlled release, those kind of formulations. We are very poised to do those filings next year, particularly with the Generic Drug User Fee Amendments (GDUFA), the commitment from the FDA, to approve the ANDAs as per the predefined timeline. So, the approvals should come fast and we should be able to make those ANDA approvals, convert them into the numbers faster than before. Q: You have a couple of facilities coming up, a new facility in Guwahati. What is the status of the current facilities in terms of even regulatory inspections? A: As we speak, we have four formulation facilities and one Active Pharmaceutical Ingredient (API). Out of that, the last one, which we have put up in Dahej, Gujarat, that was done with a spend of about Rs 220 crore. We are taking the regulatory filing batches with that. In about a year’s time, we are expecting the regulatory approvals particularly from the US FDA and WHO for that facility. Besides that, we are investing in formulation facility again in Guwahati with a Capex of about Rs 300 crore. Hoping to commercialise that before March 2017. Dahej is an special economic zone (SEZ). Guwahati is again going to be tax exempted. So, with these two facilities, we are quite, we are going to take care of all the growth capacities which will require in the future. Q: Recently, we have seen a spate of US FDA issues with a lot of pharma companies which have come up. What is Ajanta Pharma’s strategy in terms of ensuring that you are on top of your game when it comes to regulatory issues? What do you do differently or what have you started doing differently? A: There is no two issues for any facility or any company are same. It depends on the situation, on what they come across and what they find. But as much as it is said, what we have done is, we have invested significantly in the quality systems. From 5 years back and we have had a number of FDA inspections for our facility which have been very successful. So, there has been constant training, constant anticipation of the FDA requirement which keeps on going up and up every year. And the only way you can address is if you are on the top of the game and we believe that we have done enough investing in the people in training and infrastructure, automation as much as possible to give the comforts when the FDA comes in, that we are up to the mark and we are buttoned up.