DPR & CMA Data on Nifedipine tablets (sr 20 mg)

Nifedipine tablets (SR 20 mg) are a pharmaceutical formulation utilized primarily for the management of hypertension and angina pectoris. Nifedipine, a calcium channel blocker, functions by inhibiting the influx of calcium ions into vascular smooth muscle, leading to vasodilation and a subsequent decrease in blood pressure. The sustained-release (SR) formulation provides a gradual release of the drug over an extended period, allowing for once-daily dosing which improves patient adherence and outcomes. This particular strength makes it an attractive option within the cardiovascular disease management sector. Clinical studies have consistently demonstrated the efficacy of nifedipine in lowering blood pressure and alleviating anginal symptoms, thereby enhancing the quality of life for patients suffering from these conditions. Production of SR formulations requires advanced technology and adherence to strict quality standards to ensure the release profile is maintained, crucial for therapeutic effectiveness. The Nifedipine market is supported by a growing aging population and increasing prevalence of chronic diseases such as hypertension, creating a significant demand for reliable and effective medications. However, the presence of generics in the market presents a challenge as cost is a critical factor for many consumers. Regulatory hurdles, changing health guidelines, and emerging treatment alternatives also necessitate ongoing vigilance and innovation in this sector. Overall, the nifedipine SR tablet represents a vital asset in cardiovascular therapeutics, with its growth potential tied to ongoing clinical advancements and market dynamics.

• Increasing prevalence of hypertension and cardiovascular diseases globally
• Growing geriatric population requiring chronic disease management
• Rising demand for sustained-release formulations enhancing patient compliance
• Potential for expansion in emerging markets with improving healthcare infrastructure

Total capital investment ranges from ₹660,000 to ₹46,200,000 depending on the scale of operation. This covers plant and machinery, civil work, pre-operative expenses, and working capital. Larger scales require proportionally higher investment but typically offer better returns.

At the larger investment scale, the expected break-even is approximately approx. 5 years at approximately 70.00% capacity utilisation. Smaller setups may reach break-even sooner due to lower fixed costs relative to the capacity.

• Nifedipine API (Active Pharmaceutical Ingredient)
• Excipients for sustained-release formulation (such as polymers)
• Packaging materials for ensuring product stability

• Well-established efficacy in hypertension and angina management
• Sustained-release formulation improves patient compliance
• Strong brand recognition in existing markets