After successfully launching the world’s first ever generic Pentosan Polysulfate Sodium (PPS) for interstitial cystitis, and now on track to hit the Rs 50 crore milestone, Swati Spentose founder Vishal Jajodia believes that niche APIs are both a social need as well as sound business strategy By Sachin Jagdale
When talk turns to quality APIs and formulations, Mumbai-based Swati Spentose Pvt Ltd (SSPL) figures as one of the most sought after manufacturers, thanks to its primary focus on neglected diseases. SSPL is part of the 45-year-old V group, with clients in over 60 countries worldwide. Besides manufacturing, the company also specialises in marketing of APIs and formulations and is also investing in R&D and clinical studies on niche molecules for the nglected diseases sector, both in India and for global markets.
It all started in the 1970s when the late Chairman, Narayan Jajodia, arrived in Mumbai from Kolkata to specialise in the trade of APIs. He set up a distribution business within India and across 30 countries thanks to his skills and network, and he soon represented some of well known pharmaceutical manufacturers in Europe.
SSPL was incorporated much later in December 2005 as a manufacturer of APIs for regulated markets, focused on polysaccharide chemistry as well as more established speciality ingredients. The same year saw the commissioning of the manufacturing facility for Pentosan Polysulfate Sodium (PPS) in compliance with guidelines of international regulatory agencies like the US FDA, UK’s Medicines and Healthcare products Regulatory Agency (MHRA), European Directorate for the Quality of Medicines (EDQM), Therapeutic Goods Administration (TGA) of Australia, Medicine Control Council (MCC) of South Africa.
Under the helm of the second generation, the company’s current Chief Executive Officer, Vishal Jajodia, Swati Spentose developed the orphan molecule of PPS and successfully launched the world’s first ever generic PPS for interstitial cystitis, a condition manifested as painful and frequent urination. The company is the only other commercially established manufacturer of PPS in the world apart from the originator, Janssen Pharmaceuticals/ Johnson & Johnson. He has been on the boards of councils like Chemical Export Promotion Council (Chemexil), Pharmaceuticals Export Promotion Council of India (Pharmexcil), Indian Drug Manufacturers’ Association (IDMA) and Federation of Indian Export Organisation (FIEO) at various positions since the last 16 years including vice chairman, under the Ministry of Commerce and Industry, Government of India, and is also active in on policy formation initiatives as part of these associations.
Venturing into challenging territory
The company started with the basic pharmaceutical supplies of bulk drug but since the past 15 years, evolved to complex polysaccharide chemistry. “Very few people are able understand polysaccharide chemistry and to take it successfully to the market. The challenge today is to sustain the ever-growing need of the regulatory bodies and government norms such as environment and Swati Spentose has made sure that it will be able to cater to all the needs for years to come,” says Jajodia.
The pharma sector is a chemical-based industry and happens to be one of the leading polluting industries in the world. However, this is where Swati Spentose has proved itself different from its peers.
With zero discharge achievement even after manufacturing products like phenytoin sodium, SSPL has become a success story for such bulk drugs and other manufacturing plants in the highly polluted area of Vapi, an industrial township in Gujarat, dominated by chemical manufacturing units.
Jajodia opines, “As we say, change is the only constant. We also have to change with the times, as the markets are getting very stringent with new regulation from all over the world. We have seen an array of changes with respect to the products made in the early era and now.” He also mentions that while many companies face challenges due to the chemistry, analytical and stability of the products like Dextran, ES, PPS to name a few, SSPL is one of the handful of players in the hormones and steroids sector, since these entail challenging and complicated manufacturing processes.
The company’s manufacturing units are located in Vapi, Gujarat. Swati Spentose Unit I is housed in a 6,000 sq mt facility (64,560 sq ft) with 3,978 sq mt (42,800 sq ft) manufacturing and storage area having world class utilities. They have high efficiency and environment-friendly operations consisting of multipurpose and dedicated polysaccharide blocks. Ultra filtration block has an annual capacity of 18 MT to manufacture polysaccharide and multipurpose block has a capacity of 300 MT capacity.
SSPL seems well placed in terms of positioning as bulk drug manufacturing has become the most critical but unfortunately the weakest link in today’s pharmaceutical supply chain. Jajodia’s claims seem to be borne out by the eight per cent growth rate over the past five years and with India billed as the best option ahead of China when it comes to reliability and consistency in quality, SSPL seems set to continue on track.
Listing the infrastruture put in placed over the past decade, Jajodia points to facility consisting of a world class line reactors, stainless steel reactors, high purifying water system etc, non-polluting captive effluent treatment facility, fully compliant with environment, health and safety guidelines as per global and industrial standard. He projects that the facility and product mix has a potential of generating revenues around $150 million per annum at 100 per cent capacity in the next five years.
Small is the next big
Interstitial Cystitis (IC) is a neglected disease condition in India and indeed across most parts of the world, due to lack of awareness among affected patients. The medical fraternity is still struggling to find the right diagnosis for this disease. There are almost 40,000 prescriptions in the US alone for this drug. SSPL thinks that a lot can be done in this disease category.
“India being a huge country, we believe that we have only touched the tip of the iceberg. Also, pentosan is available in very few countries around the world. We plan to expand our market to reach patients suffering with the disease. Also, we wish to bring new delivery solutions for this disease, even though we have to pump in a lot of investment in research, but we are committed to bring in new solutions in this area. We want to see patients smile,” informs Jajodia.
Jajodia is confident about the company’s ability to take healthcare to every needy person in the country and across the globe. He explains, “Inspite of being a small company (in terms of profits/turnover), if we can work for the better (health) of needy patients by fighting against all the odds (huge investment, less profit generation, research), we are sure that it will create an awareness so that it will reach out to the masses/ patients.” He points out that most patients end up suffering silently, as they are unaware about the disease, and in most cases it is misunderstood as a urinary infection.
SSPL’s Jajodia believes that bulk drug manufacturing companies will play a major role in the growth of the pharma sector since India will overtake China in product quality and pricing. Products like biosimilars, polysaccharides, i.e. products with low volume – high price, will be the way forward for pharma companies.
“We believe niche molecules and polysaccharide chemistry are the growth model in future for the company. Looking at the scenario, the companies have plans for expansion in the area of biosimilars and orphan drugs such as mucopolysacchridosis,” says Jajodia signing off on a positive note.