cover )
W
hen 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-yearold 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.
The beginning 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
28 EXPRESS PHARMA November 1-15, 2015
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 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 Vishal Jajodia Chief Executive Officer SSPL
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 op-