Sionc Pharmaceuticals: A Global Leader In Innovative Api Manufacturing With Excellence At Par

J. Subba Rao, Director - Operations

J. Subba Rao

Director - Operations

The Active Pharmaceutical Ingredients (API) market in India is experiencing robust growth, fueled by increasing domestic and international demand for pharmaceuticals. Significant developments include the implementation of stricter regulatory standards and the government's Production Linked Incentive (PLI) scheme, which aims to boost domestic production and reduce import reliance. The sector is also seeing a shift towards innovation, with increased R&D investment in novel and high-value APIs, along with a focus on sustainability and environmentally friendly practices. Consolidation through mergers and acquisitions further characterizes the industry, enhancing capabilities and market reach.

SIONC Pharmaceuticals has established itself as a trusted name in the global generic drug industry, specializing in the production of complex and niche Active Pharmaceutical Ingredients (APIs) across various therapeutic categories. Since its inception in 2010, the company has taken a customer-centric approach, contributing reliably to regulatory markets. With a strong presence in India, as well as in the US and European markets, SIONC has carved a niche through its commitment to high-quality standards and innovation. The company's goal is to become a leading global pharmaceutical player by offering world-class products that combine superior quality with cost-effectiveness, positioning itself as a preferred partner in the industry. By consistently delivering excellence in product quality and service, the firm continues to gain recognition among international manufacturers as a key contributor to global healthcare.

“Quality is at the heart of our company, supported by a strong research and development program. As an R&D-driven organization, we prioritize innovation to ensure top-quality products. Our dedication to excellence in R&D enables us to meet the evolving needs of the global pharmaceutical market and maintain our competitive edge," says Subba Rao Jetti, Director- Operations.

SIONC Pharmaceuticals takes pride in its core team of highly qualified professionals who have been integral to the company's success over the years. The company, spearheaded by Subba Rao Jetti, is committed to developing optimized processes that prioritize both quality and costefficiency. The company is open to collaborative research in chemistry to enhance its research and development efforts further. SIONC continually upgrades its procedures, technologies, infrastructure, and product quality to maintain excellence. To achieve this, continuous training is provided to personnel involved in quality assurance, ensuring that high standards are upheld.

With a strong presence in India, as well as in the US and European markets, SIONC has carved a niche through its commitment to high-quality standards & innovation

J. Subba Rao, Director - Operations

Excellence in Quality Management and Global Compliance

SIONC Pharmaceuticals has developed a robust quality management system, ensuring the functional independence of its quality units, Quality Assurance (QA) and Quality Control (QC), from the manufacturing process.

The company's approach to quality assurance is centered on implementing an effective system that incorporates current Good Manufacturing Practices (cGMP) for stringent quality control. SIONC invests in top-tier infrastructure and specialized personnel to meet the high standards set by the quality system. The company boasts a strong international certification portfolio, including certificates from the USFDA, German Authority, and KFDA, along with an EU written confirmation from CDSCO. It holds WHO-GMP, GMP, and GLP certificates and adheres to ISO standards 9001:2015, 14001:2015, and 45001:2018. The facility has been inspected multiple times by leading authorities such as the USFDA and German regulators.

The company operates two state-of-the-art manufacturing facilities, with a total plant capacity of 225 MT for Unit 1 and 450 MT for Unit 2. The facilities built up areas of 9000 Sq.Mt and 18000 Sq.Mt and feature advanced infrastructure, including a reaction volume capacity of 126 KL. Unit 1 specializes in API production with batch sizes ranging from 0.5 kg to 360 kg and oncology APIs from 0.5 kg to 27 kg, utilizing seven clean rooms. Unit 2 excels in larger batch sizes from 10 kg to 700 kg and handles high-pressure reactions using specialty reactors and an oncology block equipped with advanced isolators including reaction volume of 360 KL. The company's commitment to global regulatory standards ensures consistent product quality and enables reliable worldwide distribution with a robust turn around capability of Rs 180 crore extent, these facilities are designed to meet international requirements and deliver highquality products globally.

The company is focused on the regulated market, emphasizing low-volume, high-value products, particularly for the generic drug industry. With a strong quality policy in place, the company consistently delivers products that meet and often exceed customer expectations, adhering to stringent US and European regulatory guidelines. This commitment to quality positions SIONC as a trusted partner in the global pharmaceutical industry.

The primary goal of the SIONC management is to create an environment that empowers employees to work efficiently and productively. At SIONC the management team plays a critical role in the organization's success by setting the direction and strategy of the company and ensuring that it is executed, effectively by allocating resources effectively, monitoring operations efficiently and building a strong organizational culture by developing and leading a high-performing team.

Charting the Future

Supported by a robust financial system and customer-centric policies, SIONC is poised for ambitious growth. With an established client base comprising leading pharmaceutical companies both domestically and internationally, the company aims to strengthen its market presence. The company is committed to enhancing accessibility to quality, cost-effective healthcare solutions for end customers, and promoting healthier lives. Concurrently, the company prioritizes environmental stewardship, implementing rigorous waste minimization practices, effective segregation, proper storage, and safe disposal to protect the environment.

“We are driven by our mission to win global customers through innovative pharmaceutical products that excel in quality and cost-effectiveness, aiming to be the preferred partner in the industry. Our vision is to emerge as a leading global pharmaceutical company, creating value for our customers by consistently offering top-notch product quality and dedicated service. We aspire to be a significant contributor to global markets, setting standards of excellence and making a meaningful impact worldwide”, concludes Subba Rao Jetti.

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