The active pharmaceutical ingredient (API) market in India is poised for remarkable growth, driven by backward integration and adherence to stringent quality standards. By producing most of the raw materials required for manufacturing APIs domestically, Indian com­panies have achieved cost competitiveness and superior quality control. Indian APIs are now the preferred choice in major global markets, including Europe, the US, Japan, Ko­rea, and Brazil. At the forefront of this evolution is Venkata Narayana Active Ingredients (VNAI), a Chennai-based API supplier reshaping the landscape with its cutting-edge ap­proach since 2007.

VNAI integrates cutting-edge technologies to enhance its manufacturing processes while emphasizing green and clean chemistry, which not only reduces costs but also ensures compliance with environmental standards. The focus on sustainable practices allows the company to produce high-quality APIs efficiently and cost-effectively. By being highly backward integrated – up to N-6 or even N-9 in some cases – VNAI maintains strict control over the entire production process, ensuring consistent quality and competitive pricing.

“As an organization deeply committed to quality and compliance, it is in our DNA to ensure that every API we manufacture is highly backward integrated”, highlights Chandra Kumar Verma, director at VNAI. The company’s deep backward integration allows for stringent quality control, particularly in impurity profiles, including nitrosamine and azido impurities, that usually stay undetected at N-3 and N-4 levels. Furthermore, by avoiding Class-1 solvents and adhering to environmental, health, and safety (EHS) standards, VNAI positions itself as a zero-liquid discharge company. This dedication extends to the company’s research and development (R&D) processes, ensuring scalability and compliance with global efficacy and safety guidelines.

Market Leader in Cardiovascular and CNS Segments

VNAI has established a strong presence in specific therapeutic segments such as cardiovascular and central nervous system (CNS). The company aspires to maintain its market leadership in these areas by continuously adding new molecules and expanding its global footprint. VNAI’s strategy includes global filings and approvals for all its products, enabling the company to engage with key customers worldwide. This approach has helped the company build a sustainable business model with a well-organized production and inventory planning system.

VNAI’s future plans include a significant capacity expansion of approximately 250 to 300 KL within the next 12 to 16 months to produce cost-competitive products in cardiovascular, CNS, and other niche areas. The expansion aims to increase the company's turnover by approximately $25 million over the next three years through new molecule development and strategic customer lock-ins.

Tailored Approach to Customer Requirements

VNAI’s products meet the rigorous Japanese pharmacopeia standards, providing a unique advantage to clients. Additionally, the company’s streamlined regulatory strategy, which includes filing a single Drug Master File (DMF) across multiple geographies, simplifies the approval process and enhances market accessibility. “We aim to be a market leader in all the 15 to 20 APIs that we currently produce. As a result, most of our products are on continuous manufacturing, with a maximum lead time of 8 to 10 weeks, which, in turn, helps our clients maintain their inventory levels more effectively”, explains Verma. With efficient supply chain management, including just-in-time inventory practices, the company guarantees on-time delivery and continuity of supply, fostering strong customer confidence and long-term partnerships.

VNAI ensures clients success through its diverse teams of experts with over two decades of industry experience, spanning R&D, regulatory affairs, operations, supply chain, and IT. A unique mix of employees from various teams helps execute strategies for different types of clients, which further strengthens VNAI’s impact on its clients’ business. For originators and innovators, a cross-functional team led by the R&D head handles inquiries and technical discussions. In specialty chemicals, a dedicated team manages commercial and technical requirements, ensuring seamless project execution from R&D to commercial manufacturing. For generic clients, VNAI’s robust sales and business development team coordinates with production and supply chain teams to meet specific requirements and timelines.

Aiming for a Top-Three Position

Since its inception, VNAI has navigated significant challenges, including price competitiveness against Chinese intermediaries. “We emphasized transparency and proactive communication with our clients to mitigate these challenges. Explaining the impact of price fluctuations and maintaining consistent quality and supply has helped us retain their trust and loyalty”, adds Verma. Today, the company has clients across India, Europe, Brazil, Korea, Japan, China, the US, and the Middle East.

VNAI is on a growth trajectory, with plans to introduce four to seven new API molecules annually, along with new specialty chemicals, while also exploring opportunities in new chemical entities (NCE) with originators. The company aims to achieve EcoVadis certification by the end of the next quarter, reinforcing its commitment to EHS norms. Furthermore, VNAI’s financial targets include maintaining a gross margin greater than 55 percent and EBITDA levels between 20 to 25 percent. “With a strong foundation built on backward integration, green chemistry, and regulatory compliance, we aspire to be recognized for our quality and delivery commitments and, eventually, achieve a top-three global position for all our products”, concludes Verma.