Alembic Pharmaceuticals has achieved a significant milestone in its product portfolio expansion. The company announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.025%.

Product Details and Market Potential

The approved Tretinoin Cream is therapeutically equivalent to Bausch Health US, LLC's Retin-A Cream, which serves as the reference listed drug product (RLD). This topical treatment is indicated for acne vulgaris, a common skin condition affecting millions worldwide.

According to IQVIA data, the Tretinoin cream market has an estimated size of US$ 94.00 million for the twelve months ending June, highlighting the potential commercial value of this approval for Alembic Pharmaceuticals.

Expanding Product Portfolio

This latest approval further strengthens Alembic's position in the generic pharmaceutical market. With this addition, the company now boasts a cumulative total of 224 ANDA approvals from the USFDA, comprising:

• 202 final approvals
• 22 tentative approvals

Company Profile

Alembic Pharmaceuticals, established in 1907, is a vertically integrated research and development pharmaceutical company. The firm has a strong presence in both domestic and international markets:

• Manufactures and markets generic pharmaceutical products globally
• One of the leaders in branded generics in India
• Employs a field force of over 5,500 for marketing its brands
• Operates state-of-the-art research and manufacturing facilities approved by regulatory authorities of many developed countries, including the USFDA

This USFDA approval for Tretinoin Cream represents another step forward in Alembic Pharmaceuticals' ongoing efforts to expand its product offerings and strengthen its position in the global generic pharmaceutical market.

Alembic Pharmaceuticals , a leading Indian pharmaceutical company, has announced strong financial results for the first quarter, demonstrating resilience and growth across its business segments.

Financial Highlights

• Revenue from operations increased by 10% year-over-year to ₹1,710.72 crore
• EBITDA grew by 20% to ₹288.00 crore, with EBITDA margin expanding to 17% of revenue
• Net profit rose by 15% to ₹154.38 crore
• Earnings per share (EPS) improved to ₹7.85, up from ₹6.84 in the previous year's corresponding quarter

Segment Performance

Alembic Pharma's growth was driven by strong performances across its key business segments:

India Branded Business

• Delivered a 5% year-on-year growth, reaching ₹599.00 crore in revenue
• Showed good momentum in specialty therapies, particularly in Gynaecology, Cardiology, Anti-Diabetic, Ophthalmology, and Animal Healthcare

US Generics

• Grew by 13% to ₹523.00 crore, despite ongoing pricing pressures
• Successfully launched 4 new products in the US market during the quarter

Ex-US International Generics

• Reported an impressive 21% growth to ₹328.00 crore
• Reflects the company's strategic expansion in international markets

API Business

• Remained stable with a 1% growth to ₹261.00 crore
• Balanced volume growth against pricing pressures

Operational Highlights

• R&D expenses stood at 8% of revenue
• Received 6 ANDA approvals during the quarter
• Cumulative ANDA approvals reached 223
• Successfully introduced 3 new products in the Indian market

Management Commentary

Mr. Pranav Amin, Managing Director of Alembic Pharmaceuticals Limited, commented on the results: "We began the quarter on a strong note, delivering revenue growth across all businesses. The growth was driven by a 21% increase in RoW markets, reflecting our strategic expansion and disciplined execution across geographies. Despite ongoing pricing pressure, our US business grew by 13%, supported by volume gains. As we ramp up utilization of our new manufacturing facilities and continue to drive cost optimization initiatives, we expect to benefit from improved operating leverage."

Future Outlook

Alembic Pharmaceuticals is well-positioned for continued growth, with a robust pipeline of over 15 product launches expected. The company's focus on expanding its presence in international markets, coupled with its strong R&D capabilities, is likely to drive future performance.

The company's strategic initiatives, including the ramp-up of new manufacturing facilities and ongoing cost optimization efforts, are expected to enhance operational efficiency and profitability in the coming quarters.

Conclusion

Alembic Pharmaceuticals' quarterly results demonstrate the company's ability to navigate challenging market conditions while delivering solid growth across its diverse business segments. With a strong product pipeline, expanding global presence, and focus on operational excellence, Alembic Pharma appears well-equipped to capitalize on growth opportunities in the pharmaceutical sector.