At the Pharma Expo 2025, SmallCap Spotlight caught up with Dr. Priya Singh of FDC Limited to discuss the company’s commitment to quality, global reach, and R&D-led innovation. From USFDA-aligned manufacturing standards across domestic and export markets to adopting AI and paperless laboratories, tune in to the conversation to know more about the company’s journey.
Hello and welcome. You’re watching Small Cap Spotlight. I am Anisha Jain and we are right here at the Pharma Expo 2025 and we’re in conversation with Dr. Priya Singh of FDC Limited.
Anisha Jain: Priya, hi, thank you so much for joining us today.
Priya Singh: Yeah, hi, thank you for giving this opportunity.
Anisha Jain: So Priya, first up explain to our viewers what does FDC do?
Priya Singh: Yeah, FDC is into manufacturing of oral solid dosage forms, capsules, tablets, syrups, suspensions, cephalosporins, ophthalmics and you all must be knowing the ORS which is Electral, the brand of FDC.
So they are into different segments and we operate into different geographies also and FDC has a lot of accreditations right from the USFDA to the MHRA to the WHO as well as the local accreditations from the CDSO. So we are operating across geographies and we have all the major accreditations which are required for the GMP.
Anisha Jain: So if I had to ask you what part of your business is domestic facing and what part is export facing, how would you split it?
Priya Singh: So we do not have like that where like something is very specific to domestic or very specific.
So whatever we manufacture, we manufacture into a common facility which is for the domestic as well as for the US. So there is no differentiation between the quality standards for the domestic as well. So that is one best thing about FDC is like one system for all.
Anisha Jain: That’s good to hear. So whatever is USFDA approved is also something which we are getting.
Priya Singh: Do not have different standards for US or a different standard for domestic.
The standards remain the same, the manufacturing sites remain the same, the laboratory remains the same.
Anisha Jain: So give me a few more details in terms of where do you have your manufacturing sites? What’s the scale of the business right now?
Priya Singh: Yeah, so we have a manufacturing site across the country. So for cephalosporins, we have a manufacturing site at Baddi location and for our optal mix, aerosubstances, suspensions, like the liquid category we have at our Aurangabad and for the solid oil, rosacea forms, we have a manufacturing site, two sites at our Goa location.
And for the ORS category, we have one dedicated site at SINNER as well as ORS products like electral are manufactured at Aurangabad as well as Goa.
Anisha Jain: Which of course is your main product and everybody knows FDC as that company.
Priya Singh: We also have our APIs also.
The API manufacturing plant of FDC is located at Roha.
Anisha Jain: That’s good to hear but tell me Priya, what role do you play in the company right now?
Priya Singh: So I had the analytical R&D for FDC and the R&D at the FDC is responsible for developing all the analytical methods and transferring it to the QC sites. So we are majorly responsible for the development, the method validation, the method transfers and ensuring that there are no troubles while executing the methods at the QC laboratories.
So what we do is like the recent developments, I could say like we ensure that the efficiencies of the QC laboratories are increased. So in terms of that, we are ensuring to have more cutting edge technologies and methodologies being implemented at R&D facilities. So we could say like our QC sites have already implemented like Raman spectroscopy for identification tests and so many other technologies are being in the phase of implementation which we will soon hear from FDC.
Anisha Jain: Well, looking forward to that because technology is a new thing, right? You have to be ahead of the curve. Otherwise, obviously, it’s difficult to catch up. But since we’re talking about technology, if I can take a step back Priya and understand from you, what role can AI play in all of this?
Priya Singh: Yes, very good question. Now, we all know that there is no escape from this, right? So instruments which we are implementing, they already have these AI features embedded in them and that is definitely helping. So see, there is a fear in the minds of most of the employees that AI is going to take over jobs. So that’s definitely not going to happen.
With AI, we all know it is just going to improve the efficiency of the laboratories. And more efficiency is more productivity, more productivity is more revenue. So that is how it is going to help.
So when we go for the new technology, we see there is some of the other AI features being embedded from the manufacturer side also. And with respect to I would say digitalization, already FDC has moved into digitalization for the QMS systems for the laboratory systems also. Now in our laboratory, even though it is an R&D laboratory, not much of the R&D laboratories have gone to a paperless laboratory, but we are already moved towards a paperless laboratory and we are almost 80% completed the process.
So that is one step which is towards sustainability as well as green innovation also, where we have moved to. Our QC laboratories are also already implementing LIMS systems where they have gone ahead one step ahead of major of the companies which are there.
Anisha Jain: So great, you are growing the technology by leaps and bounds and that, you know, people-less laboratories does sound very interesting, but that clearly means that the company is investing a lot in R&D.
Priya Singh: Yes, they are investing a lot in R&D, not only in terms of paper-based systems, but also in terms of instrumentation. So R&D laboratory at FDC has all the high-end instruments which are required for, maybe not many of the big companies also would have. So our directors and our senior management staff are very much aligned to, and they are more technical in nature also, and they are more aligned to all these things and where they understand the requirements of the business meeting it, as well as the regulatory demands and they are always aligned to it.
That is the major support what we as technical heads get from them because their vision is very clear that they want to have quality in the system. So quality has never been compromised at FDC and that is what it makes the best place for us to work.
Anisha Jain: Yeah, I know and I love the fact that everybody is aligned because it flows from the top and then you get the freedom to do what’s best for the consumer, what’s best for the company.
But talk to me a bit more about leadership. Who are the people at the management level who are leading the operations?
Priya Singh: So we have different people who are leading the operations. So we have like a corporate team who majorly takes care of all the functions across the sites and all.
So we have a dedicated team at corporate who is very technical and because of this, many of the operations are handled in a very nice way. See, once you know that if the leader is good, the team follows it. And because of these great leadership skills which are there at the level and the senior management role, it helps us all to have that alignment to the business rules.
Anisha Jain: Sure. But you know, FDC is sometimes treated as synonymous with Electral, you know, because that’s your key product. I want to talk to you a bit more about that because it’s not very highly scientific in terms of let’s say the molecular, you know, changes which are happening, neither the delivery of it is very technical. How do you ensure that you stay ahead of the curve and you continue to grow that market for yourself?
Priya Singh: See, when it comes to Electral, actually it is an ORS system. But you know, every layman or every person would have the name Electral in his name. Nobody would go to a medical store and even ask for a system like called as, give me ORS.
Everybody would say Electral and that is, we stand ahead of it. And it is not only about like being ORS as one system, we have a different category in it with respect to flavors, with respect to also we have a segment which is into the energy drink also. And that is not only the category which we have in for FDC, we are already operating in different segments like into tablet capsules.
So we have this for the US markets also. And we have a wide range of ophthalmics which are already commercialized in the US market. So our facility at Aurangabad is and we had a recent FDA inspections, US FDA, three consecutive inspections, we have got 0 for 83s.
And that is where we stand in today’s time. When we see like major companies being impacted by the US FDA inspections, but being like I told you, we have a corporate team who is very technical and who takes care of all the functions of the QC laboratories. And with their experience and expertise, it’s what has made FDC have these successful US FDA inspections.
Anisha Jain: Yeah, I mean, three back to back successful with zero observations, even the top companies are not able to deal with that.
Priya Singh: One of them was sterile. So you must have seen like none of the sterile companies get away with zero inspections.
And that is where we come from. And that is what motivates us also employees to be in the company where the senior management are always aligned to have equality in the system.
Anisha Jain: So if I had to ask you, what’s the biggest challenge that you know that you see ahead of yourself?
Priya Singh: As such, I would not say there is much challenge because see if you yourself are more aligned to adopting new technologies and methodologies, then I think that should not be a challenge.
If you have that relation within you, like if you’re reluctant, and if you have that within you that I do not want to change with the change. So if you are more adaptive to the change, I think nothing is more challenging. See, the industry came up with so many things, elemental impurities came in, nitrosamine came in, but with time people started adopting it.
So you do not have an escape. It is only as you face those challenges, you have to adapt yourself to it and I think with the scientific expertise what we have, it would not be difficult. And in today’s world, if you see information is available with you, it’s not like earlier, like when you had to go to the libraries and search for the books and today information is available, networking is there, you have your interstitial colleagues, you have guidances, and if you have the right knowledge, and if you can deliberate on those things, and then I do not feel that that should be a challenge for you.
Anisha Jain: Okay, so no major challenge that you are fearing at this point of time, but you talked about how you have a lot of global exposure as well, you exposed to a lot of market as well. Tell me what’s the growth looking like there? Is there a specific product that you know you’re seeing increased demand for? And with this global disruption happening of the entire trade tariff and that overhang, how do you see yourself placed?
Priya Singh: See, I do not see it because as far as I know that working with FDC, FDC is working aggressively now and soon you will be hearing that whatever approvals are lined up in the near future and it was like, not like before that we’ve had very less approvals from the USFDA, but now FDC is working aggressively into more formulations also, which maybe I would not like to mention right now, but soon you will be hearing from us like where FDC would stand in the near future. So I would just definitely like to say like with the rate of growth what has happened with the company, definitely we have a very successful future.
Anisha Jain: Very successful future and you’ve got me excited by talking about the pipeline that you have at your hand, but if I can narrow it down a bit more about exports because you have all the certifications which are needed in any case, so the total addressable market for you becomes huge. What kind of growth rate do you anticipate, let’s say either in exports or are there new geographies that you’re targeting or what’s the roadmap there?
Priya Singh: There are a lot of geographies we are targeting like from in the case of Ophthalmics or OSDs and I think see we already have approvals in the US so it becomes very easy for us to enter the other geographies also with this, but now the only challenge what we see like is like even the ROW markets which were not demanding much on regulatory things like they are also now demanding same as like the US. So and but still we do not face much of a challenge over here because like I said like we have one common manufacturing facility for both the US as well as the other markets, but it is like there are more diverse geographies which our company is looking forward to.
We already exist in more like 50 plus geographies so that is where we stand.
Anisha Jain: Okay and are you looking at you know expanding your capacities etc or do you think the capacity utilization right now gives you the room to increase capacity very soon?
Priya Singh: FDC is into increasing yeah the capacities into expansion also. We’ve already started the expansion maybe you have already seen it, yes.
Anisha Jain: And what about US, are you looking at setting up some facilities in US itself?
Priya Singh: Not sure as of now.
Anisha Jain: Okay fair enough but thank you so much Priya for making time and speaking with us and talking to us about what really lies ahead for FDC. Really looking forward to new innovations from your end.
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