Vijaya Prakash

Managing Director

The Indian drug formulation market has experienced significant growth in recent years, driven by increased demand for pharmaceutical products and innovations in drug delivery systems. Competition has intensified, with new players entering from various states. Having said that, one of the major challenges faced post-COVID was the shortage of APIs, primarily due to the industry's dependence on Chinese intermediates. Furthermore, lack of players who can maintain their consistent quality and reliable supply.

This is where SP Accure Labs (SPAL) steps in. Today, SPAL has strategically positioned itself as a leading manufacturer with an extensive oncology product portfolio ranging from tablets and capsules to complex formulations such as lyophilized injections, nanoparticles, and liposomes. Unlike competitors with limited product ranges, SPAL prides itself on offering a comprehensive suite of oncology products, ensuring it stands out in the market. This diverse portfolio, combined with adherence to European GMP standards, has enabled the company to maintain a strong customer base and secure its position as a trusted supplier.

Moreover, SP Accure Labs has robustly built alternative vendors, stabilizing their supply chain and enabling continued growth. The company's facility, initially established in 2014 and expanded in 2016, underwent a four-fold expansion in 2020, allowing them to increase production capacity and meet rising demand. In the oncology sector, SPAL has managed to stay ahead of the competition by partnering with leading companies such as Zydus, Intas, Abbott, Torrent, and Emcure, which have robust marketing and sales teams.

“One of our key products, paclitaxel albumin-bound nanoparticles, used for breast cancer treatment, has significantly boosted our market growth. This novel drug delivery system, which targets cancer cells specifically, has become a cornerstone of their product portfolio, contributing to annual growth rates of 30-50 percent. Furthermore, we have been successfully supplying products to state government tenders and exports globally, with registrations across markets in Europe, the UK, Canada, Australia Colombia, Peru, Chile, Paraguay, Honduras, Guatemala, Morocco, Tunisia, Nepal, South Korea, Russia, Belarus, Yemen, Syria, Ethiopia etc”, highlights Vijaya Prakash, Managing Director, SPAL.

“We have also expanded our product portfolio, now offering around 150 marketed products and more than 200 in development. All our products are focused towards improving treatment efficacy and minimize side effects. The recognition of our R&D facility by the Department of Scientific and Industrial Research (DSIR) further highlights its commitment to innovation”, he adds.

A Promise of Optimal Quality Standards

A critical aspect of SPAL's success lies in its commitment to customer satisfaction and rigorous quality control. To maintain high standards, the company conducts regular follow-ups with clients, ensuring their needs are met. Each batch is accompanied by a Certificate of Conformity, released by the quality assurance team before dispatch, guaranteeing that products meet stringent quality benchmarks. Furthermore, the company engages in quarterly meetings with clients, particularly with the purchase and Corporate Quality Assurance teams. These interactions allow SPAL to address any concerns or feedback, particularly regarding packaging and delivery conditions. If improvements are required, alternative strategies are promptly proposed and implemented to enhance customer satisfaction. SPAL also places significant emphasis on compliance and feedback management. Should any market complaints arise, the company immediately investigates to resolve the issue.

However, in its decade of operation, the company has maintained an impeccable record, with no major qualityrelated complaints. Periodic product audits by various regulatory bodies have consistently confirmed that all products meet the highest standards. In summary, SPAL's dedication to maintaining superior quality, addressing customer feedback proactively, and fostering strong relationships with clients has solidified its reputation as a leader in the oncology pharmaceutical industry.

Furthermore, the company’s commitment to quality is demonstrated through their adherence to international standards, such as European GMP accreditation, which they have prioritized over USFDA due to the competitive landscape. Their quality assurance systems are fully digitized, ensuring data integrity and preventing any manipulation, thereby setting a benchmark that exceeds both Indian and international standards. This focus on stringent quality control and regulatory compliance has positioned SP Accure Labs as a trusted player in both domestic and global markets, particularly in Europe and the UK, where they continue to expand their footprint.

Steering the Needed Innovation

SPAL maintains its leadership in the specialty formulations segment through strong in-house Research & Development (R&D) capabilities. Its dedicated R&D facility, recognized by the Department of Scientific and Industrial Research (DSIR), allows the company to pursue innovative projects with potential government funding. Leading the R&D team is Dr A Yaswanth, who brings 15 years of oncologyfocused experience. His leadership over the past 9.5 years has been pivotal in expanding SP Accure Labs’ portfolio. The company’s R&D team is crucial in developing new formulations, which are efficiently transferred to production. This capability has allowed SP Accure Labs to build a robust portfolio of around 150 marketed products, with over 200 more in development. This innovation-driven approach keeps the company competitive, particularly in the oncology segment, where advancements are rapid.

A key aspect of SP Accure Labs' success is its proactive client engagement process. Major partners like Zydus, which sources over 15 products from the company, provide rolling forecasts for their annual product needs. Each month, the client submits detailed deliverables, and SP Accure Labs ensures that all products are dispatched by the 25th, allowing sufficient time for transportation and adherence to deadlines. Production is meticulously planned in advance, with goods manufactured a month ahead of their delivery dates, ensuring timeliness and quality.

Staying Ahead of the Curve

SPAL stands out in the specialty formulations segment due to several key factors that have contributed to its growth and success. A major differentiator is the company’s technically-sound leadership. Vijaya Prakash has a strong technical background and is deeply involved in every aspect of operations, including manufacturing, development, marketing, and quality assurance. This hands-on leadership ensures that every stage of the production process is closely monitored, maintaining stringent quality standards. By personally overseeing critical elements such as API vendor qualification, raw material supply management, and quality control, the MD minimizes supply chain disruptions and ensures that production timelines are met. Another strength of SP Accure Labs is its efficient and structured manufacturing process. The company operates under detailed plans designed by the MD, ensuring consistency, precision, and adherence to production schedules. This well-organized approach allows the company to efficiently manage its operations, contributing to timely product deliveries and maintaining high-quality standards.

Cost competitiveness is another significant advantage for SP Accure Labs. As a medium-sized company, it operates with lower overhead costs than larger pharmaceutical firms. This enables it to offer high-quality products at competitive prices, which is crucial in a highly competitive market. The company manufactures products for leading pharmaceutical companies like Zydus, Torrent, RPG, and Intas, which market these products with a 30-40 percent profit margin. SP Accure Labs’ ability to combine competitive pricing with excellent quality gives it a strong edge over its competitors.

In addition to strong internal processes, the company has cultivated long-lasting client relationships. Its commitment to timely deliveries and high-quality products has helped build trust with its clients, leading to strong partnerships with major pharmaceutical firms. This reliability, combined with the ability to scale production, has positioned SP Accure Labs as a trusted partner in the industry.

A Noteworthy Journey

SP Accure Labs has achieved several key milestones since its inception. Starting with a single facility, the company expanded in 2020, quadrupling its capacity by 2024 to meet growing demand, particularly in oncology. A major breakthrough was the development of paclitaxel albuminbound nanoparticles, a novel breast cancer treatment, driving annual market growth of 30-50 percent over five years, strengthening the company’s reputation in oncology formulations. Founded by Vijaya Prakash in 2013, SP Accure Labs swiftly grew, beginning production in 2014 and expanding into Injectables by 2016. The company’s first regulatory approval came in 2017 from Nepal’s DDA, followed by European GMP accreditation in 2018. Global expansion continued with Russian GMP certification in 2019 and accreditations from South Korea, Belarus, GCC, Ethiopia, Iran, Iraq, and Turkey, cementing its presence across Asia, Europe, the Middle East, and Africa as a key oncology player.

“Going forward, we will be focused on expanding our product portfolio to include novel drug delivery systems (NDDS) alongside its conventional dosage like Nanoparticles, Liposomes and Depot Formulations. We have increased our facility capacity fourfold to meet market demands. A key strategy involves collaboration with various international partners to develop monoclonal antibodies, a major focus for the company. By 2026, we aim to launch these monoclonal antibodies for both domestic and export markets. This strategic shift towards innovative drug delivery systems, including nanoparticles and liposomes, combined with the introduction of monoclonal antibodies, positions the company for significant growth and a market strike rate exceeding 100 percent in the coming years”, concludes Vijaya Prakash.