SmallCap Spotlight throws the spotlight on MJ Biopharm, India’s top three insulin manufacturers, specializing in anti-diabetic biotech products. With FDA and global accreditations, the company is expanding exports and aiming for US & EU markets in 2–3 years. Backed by strong R&D and a digital-first approach, MJ Biopharm is investing in the future of diabetes care with cutting-edge biotech and AI integration.
Tune in to the conversation below:
Anisha Jain: Hello and welcome. You’re watching SmallCap Spotlight. I’m here at the Pharma Expo Live 2025 and we are in discussion with the management at MJ BioPharm.Mr. Rakesh Kumar joins us to talk to us about just that. Rakesh, hi, thank you so much for making time.
So tell me first of all about MJ BioPharm. What exactly does the company do? How big it is? How long it has been in existence for? So MJ is from last 25 years.
Rakesh Kumar: So recently we have just celebrated our Silver Jubilee. And of course, MJ is in anti-diabetic manufacturing product. Of course, MJ is in other formulation also. But now the key product is like anti-diabetic product and like Insulin and their Analogs, which is now in the already market, but Analogs is coming over that market right now.
Anisha Jain: So which are the areas where you have the factory? Where’s your corporate office? What’s the overall size of the organization?
Rakesh Kumar: Our corporate office is in Nariman Point. It’s in Mumbai. One of the plant is in Taluja. And another plant is in Pune, which is in Hinjewadi Biotech Park. So there the biotech plant is there in Hinjewadi.
Anisha Jain: And you have all the traditions which are needed globally, the GMP, FDA, etc?
Rakesh Kumar: Yeah, we do have all FDA and of course, local certifications. Of course, we cleared like PICS also with the South Africa. So we do have all accreditation. But yes, we are preparing for this regulated market and everything.
Anisha Jain: Yeah, because I think insulin market and the anti-diabetic market is blowing up in a very big way because with the new launches that have happened and the other usages which are happening, the likes of Ozempic, etc, which is also being used in fat loss, etc. What’s your sense as to where the industry is headed?
Rakesh Kumar: So you were talking about the one of the product like semaglutide, which is in the loss in the fat. So now, the insulin, which I’m talking about that, their analogs, of course, semaglutide is one of the things, but there are other analogs also, they’re like insulin and the glazine and Aspart, Lispo. So these are the certain analogs, which is and they all have a different, different mode of action. But ultimately, they all have working for the control the diabetes only.
Anisha Jain: So which of these various forms are you guys focusing the most on?
Rakesh Kumar: We are, our insulin is marketed, even though glazine is also marketed, we got all approvals. But of course, the insulin and Lispo, which is under development kind of things.
Anisha Jain: So if I have it right now, the profile of the company will be around 500 crore thereabouts, right? Largely it’s domestic?
Rakesh Kumar: Domestic as well as certain ROW also, we are doing this business. Of course, since as I said, we have a fixed approval like South Africa, so we are selling our product in South Africa as well.
Anisha Jain: So how big can export really become for you?
Rakesh Kumar: See, currently, like we our product is going to like Thailand and South Africa, of course, Nepal, Bangladesh kind of things. But of course, in going forward and in the coming scenario and time, definitely our target is that we should go for the US and like European countries. So this is where we are preparing for ourselves.
Anisha Jain: And apart from diabetes, which other verticals do you have, which are becoming important and critical?
Rakesh Kumar: We have like certain generic medicines, like some tablet capsules, also certain dry injection powder also. But these all are like generic and irregular medicine. But where our expertise is like anti-diabetic. And if you see in India, this is the third company who is in anti-diabetic such kind of manufacturing. So we are the third company in India. And no other companies except Biopon, Occard and especially like MJ, no other companies are in the anti-diabetic product kind of things.
Anisha Jain: Great. So what brands etc your insulin sells under and is it all something which you do privately in your company or do you manufacture for others as well?
Rakesh Kumar: No, so we manufacture for the others also. And the brand is itself from our own.
So like Viacillin and all those is our own brand. And it’s coming in the cartridge as well as vial. So there are different, different formulations actually.
Anisha Jain: Okay. So you’re seeing large part of the focus in your in-house manufacturing and in-house production or is it also on third party?
Rakesh Kumar: No, so our mostly in-house for this anti-diabetic kind of things. But of course, certain things which we are doing for the third party manufacturing as well.
Anisha Jain: So Rakesh, tell me now about what role do you play in the company? What exactly is the business function that you cater to?
Rakesh Kumar: So I’m heading the quality assurance function for the drug substance for the anti-diabetic. And my role is that, of course, to ensure that the product which are getting manufactured in our site or company, it has to meet the all global standards and the quality and the specifications and all safety parameters so that it should not negatively harm prior to release. If I’m releasing this product, it should not go with any compromise mode.
So that’s where the quality assurance role and my role is over there. And it’s important for this, any company, the quality assurance role is for the product quality.
Anisha Jain: Absolutely. But in the recent inspections, etc, that have happened, have you managed to successfully scale through?
Rakesh Kumar: Yes, yes. So we recently, recently means last year, we got a PICS approval for this drug substance South Africa. And of course, the certain our local authorities audits are going on various customer audits.
So it’s easily we are getting through it. Of course, there are certain things, observations, which is coming. But yes, we have to have compliance and we are getting through.
Anisha Jain: Absolutely. But tell me about the expansion plans. Do you have plans to expand apart from these two manufacturing units that you talked about? And are you making some capital expenditures, etc?
Rakesh Kumar: Of course, so management has a plan. And to expand this certain facility like that substance facility, but it’s as of now it’s a plan, but execution and everything will take some time to complete it.
Anisha Jain: Oh, absolutely. It’s a long term plan that the management’s really work on. But talk to me about technology and the research and development spend because as you talked about even quality assurance is so important and these new drugs which are coming as a third in the country. What you know, what’s the plan of the investment in research and development and maintaining the technology advancement and everything?
Rakesh Kumar: Of course, so the research and development for now like management has clearly focused on that to research driven organization and that’s why the team size of the R&D is getting increased and properly established and the required facilities are getting provided by the management. And because there is a future for this, right? Until unless if you not go for the proper research and development, such kind of molecule you cannot bring to the market because it’s quite a lot of research and development, a lot of studies, then only you can successfully produce this kind of molecule and develop some kind of technology.
So, of course, the research development team is getting increased and developed like anything.
Anisha Jain: So talk about the future and how obviously investments are being made today. If I had to ask you what’s the long term vision of the company, what would you say?
Rakesh Kumar: See, long term vision is that as I talk about that in India, we are the third insulin manufacturer, right? No other one, right? So, of course, our responsibility towards the patient is like anything. And because of that, as I talk about that, we are coming with some expansion also to increase our capacity because the insulin demand in the market is to use, right? And specifically in India and certain ROW market also or certain Asia-Pacific countries also, if I can leave the regulated countries. But of course, the regulated countries also required a lot of amount of this kind of molecules and the drugs because the diabetes, you know, it’s a globally now spreading like anything, right? So this kind of medicine is really going to be very demand, not going to be, it is already demanded. But yes, to fulfill the demand, we need to come with a certain expanded facility with a larger capacity, which management is working and definitely we are into that.
Anisha Jain: You talk about the regulated markets, I just wanted to talk a bit more about that in terms of the US market, because that’s one of the biggest market when it comes to this product, right? What’s the timeline that you think you’ll be able to enter that market?
Rakesh Kumar: See, so in US, if these all are coming under the stringent regulated market, right? And the regulations are very tough. They need a lot of study, a lot of reports, a lot of studies. So we are in a process. And like, our plan is that in next two years, two to three years, we will be penetrating to this kind of market with the all audit and approvals kind of thing. So this is the plan as of now. And we are vigorously working towards the plan kind of thing.
Anisha Jain: Yeah, you have to be committed to that plan to kind of make sure that you get through in that two years timeline into the US market. But as you said, the regulations are really stringent. So a lot of back work will have to be done. But apart from this, Rakesh, what are the big industry trends that you’re watching out for? Let’s say for the pharma industry as a whole, are there some interesting new big trends that you’re watching out for?
Rakesh Kumar: The pharma is now, pharma is all about the trust and transparency, right? There should not be any unethical things. Everything has to be done ethically. And the data, whatever the things we are generating, it should be real. It should not be any altered kind of things. And that’s why the digital transformation, which we are talking about that. And in India, also, the most of the company is getting acquired and getting adapted such kind of digital transformation, right? And that’s why they are implementing like various softwares for the many managing their quality systems, even though for this like in R&D also like ELN, electronic lab notebook, and electronic logbooks, even though we are also in a position and we are also implementing to handle our quality management system, various software.
And of course, at the organizational level, we are in a process and we are implementing like SAP and all those things. So without this, you cannot imagine that as an organization, we can grow further. So, of course, we have to develop our organization and make it digitally competent and fulfilled.
And of course, this you talk about the AI. So AI is going to be very play a very crucial role for the development of any new molecule, of course, data processing, because as today also in conference, we were talking about the lot, we talk about a lot of on the AI. AI is a tool, right? But it’s a trained tool, right? And, of course, what are the input you’re going to get, you’re going to get the same output after processing.
The only difference is that the processing is going to be very faster. And it will give you a very real time process data so that the decision making will be very faster, right? Because in previous and some 20 years or 25 years back, the decision were taking a long time, right? To take a decision, a lot of data is required, a lot of evidence is required, and then you need to discuss brainstorm and then you have to go for the decisions. But now since AI and everything will make these things very faster, and the time will be cut short for the everything. So that’s the way I’m looking for it.
Anisha Jain: So it’s a positive that you’re saying so all the processing work and the other things which used to take a lot of time can be done really quickly. True that. But apart from the diabetes drug that we discussed at length, what about the cardiovascular drugs in terms of what’s the new development there? What are you watching out for in that market?
Rakesh Kumar: See, cardiovascular drugs, specifically for my company, as of now, there is no such development. But yes, there are a lot of players, a lot of companies who are doing a lot of development for this kind of things. And of course, certain biotech molecules, which is also under development, and which is going to become very soon.
But not in any company, there are certain overseas companies who are doing a development. But yes, of course, this cardiovascular sector is going to be a very next after anti-diabetic, this like a cancer is the second one. So now this cardiovascular is going to be a different market and a different research for this.
Anisha Jain: And coming back to the diabetes drugs of yours, where are you getting the raw materials from? Where do you source it from? Or all of these molecules are made in the factory?
Rakesh Kumar: The anti-diabetic product which is we are manufacturing, it’s a completely biotech product. So this is completely coming from the biotech source like microbial fermentation and everything and then it is getting a downstream process and the purification and everything. So the required raw material, of course, it is like same vendors, different vendors like salts and some acids and everything which is getting from the regular vendors.
But of course, the key raw metal, which is a microbial cell bank, which has to be developed in the sequoia and professional lab and the cell bank has to be prepared and then this cell bank has to be used for this fermentation and then the product will be manufactured. So this is a whole biotech process, bioprocess, I can talk about that, where the upstream is there, downstream is there.
Anisha Jain: And you handle the entire end-to-end at MJ Pharma.
Rakesh Kumar: From beginning to end.
Anisha Jain: So even packaging and everything is done in-house itself. So when the product is out of the factory, it’s ready to use.
Rakesh Kumar: Yes, of course.
Anisha Jain: But if I had to ask you the last question, Rakesh, what are the big challenges that you are worried about or you’re watching out for or something that you think is a very important monitorable right now?
Rakesh Kumar: See, everything, if you’re doing anything, it’s have their pros and cons. Of course, you should look for that first, how much and what are the benefits we are going to get it.
There is a negative impact also. Suppose if I’m talking about that, this data and everything, we will be processing through some AI tools or some AI software. Of course, this data will be getting stored somewhere else.
There is a threat that somebody can have the data and data security. But there is there are a lot of law which is implanted and enforced to this kind of company and the software company that if they’re getting a data, it cannot be it should not be revealed anywhere. This is this is I’m talking about the electronic data.
But if you think about that previously, which are in the phase or hard record kind of things, that kind of also that we’re getting to have. So this kind of negativity will be always there. But we should look for the positivity.
And that’s why we are coming forward and we are developing the world has moved towards and the world is adapting this kind of tools very eagerly and very effectively.
Anisha Jain: Great, Rakesh, thank you so much for helping us understand what the company does and what the way forward is. That’s the conversation that we’re having with the management of MJ Biopharm.We’ll get you more information on the other side. Stay tuned.