Rejith P R, Correspondent, India Pharma Outlook
Alembic Pharmaceuticals has received final approval from the US FDA for its generic Diltiazem Hydrochloride extended-release capsules, which are indicated for the treatment of hypertension. The capsule's anticipated market size was USD 105.3 billion for the two months ended June 2024.
The USFDA approvals play a crucial role in improving the growth trajectory and market reach of India's pharma companies. As a result, the firm can gain a reputation for producing safe and quality medicines, leading to competitive advantage, increased revenue, and promoted business stability and growth. Let us deep-dive into the impacts of USFDA approval on India pharma firms and how it strengthens their position as industry leaders as they progress in the journey.
Gaining USFDA Approvals enables Indian pharmaceutical firms to enter the US market without further complications. The market has a reasonable figure of 40 percent of the entire pharmaceutical sales, which may lure the companies to seek market entry. However, the authority carefully examines several parameters to ensure the pharmaceutical products meet the quality and safety aspects and all other standards. There is a significant demand for biosimilars and generic medicines in the US, so it becomes an opportunity for Indian pharma companies to penetrate the US market. Most major firms have significant revenue streams as the US is their largest export hub and may also encourage growing pharma firms to ponder USFDA Approvals for future business.
For instance, Sun Pharmaceuticals, a renowned India pharma firm, has captured a presence in the US market by securing US FDA approval for its branded formulations. The approval has further helped the firm secure the most significant India-based pharma player in the USA market in revenue.
"There is an incessant need to focus on the production of the highest-quality pharma products, it can be a game changer in helping the country penetrates deeper into the global market" - Deepesh Upadhyay, Asst. Vice President, Delair India Pvt. Ltd.
Indian pharmaceutical companies having USFDA Approvals create a significant impression in the minds of stakeholders and may take a step forward to invest in the companies. More importantly, the firms that have already secured USFDA approvals are less likely to have risk, contributing to high foreign direct investment (FDI) and venture capital interest. Consequently, the companies may also get into a strategic alliance with leading pharma firms, considering this an opportunity to use India's cost-effective manufacturing capabilities. Besides, the partnership can also lead to improving innovation and covering massive market reach, propelling competitiveness and growth in the pharmaceutical industry. Hence, investments and strategic alliances can bolster the entire business impact of USFDA-approved firms.
For example, Dr. Reddy's Laboratories has made a considerable investment in its research facilities and manufacturing in the USA. They have obtained approval for their complex generics, and the investment has helped the firm become a major player in the USA generic drug market, mainly in injectables and oncology.
USFDA approvals are crucial in positioning Indian pharmaceutical companies for long-term sustainability and expansion. Market entry becomes relatively easier for companies with USFDA approvals and is in a supreme position to enter significant pharma markets such as Japan, Europe and more. Besides, the companies' revenue from their business operations can be utilized to reinvest to enhance infrastructure, consider the latest therapeutic areas and more. In this ever-changing pharmaceutical landscape, investment is essential for sustainable growth, and firms should take the initiative to invest considerably, adding value to their sustainable initiatives and eventually leading to long-term success in the pharma market.
Cipla Limited is dedicated to sustainable practices that lower carbon footprints and focus on green manufacturing practices. The firm's focus on sustainable manufacturing activities aligns with its commitment to eco-friendly practices, which gain traction in the US market, where sustainability is an emerging priority for healthcare investors.
All in all, USFDA approvals significantly impact Indian pharmaceutical firms in several ways, streamlining access to productive pharma markets, creating opportunities to innovate further, and encouraging global expansion. The market is in enormous contrast with other pharmaceutical markets as it contributes a sales of 40 percent, and it will attract Indian pharmaceutical firms to penetrate the US market. As the Indian pharmaceutical companies continue to emerge and innovate, they can navigate the intricacies of USFDA protocols. They will be crucial to sustaining growth and accomplishing success in the long run.
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