Lupin Limited , a global pharmaceutical leader, has achieved a significant milestone in its manufacturing operations. The company announced that its Active Pharmaceutical Ingredient (API) facility in Dabhasa, Gujarat, has received Good Manufacturing Practice (GMP) certification from the Therapeutic Goods Administration (TGA), Australia's medicines and medical devices regulator.

Certification Details

The GMP certification was granted to the API manufacturing facility of Lupin Manufacturing Solutions Limited (LMS), a wholly-owned subsidiary of Lupin. This certification is a testament to the high standards of manufacturing practices and operational excellence maintained at the Dabhasa facility.

Impact on Operations

The TGA certification is expected to enhance Lupin's market access in Australia, potentially opening up new opportunities for the company in the Australian pharmaceutical market. It also reinforces Lupin's commitment to maintaining global quality standards across its manufacturing network.

Management's Perspective

Dr. Abdelaziz Toumi, Chief Executive Officer of Lupin Manufacturing Solutions, expressed satisfaction with the certification, stating, "We are pleased to have received the GMP certification from TGA for our Dabhasa facility. This reflects the high standard of our manufacturing practices and expertise of our team at Dabhasa."

Dr. Toumi further emphasized the company's focus on quality and compliance, adding, "As we continue to expand our global footprint, we remain focused on quality, compliance, and the highest standards of operational integrity, setting new benchmarks in the CDMO space."

About Lupin Manufacturing Solutions

Lupin Manufacturing Solutions (LMS) specializes in manufacturing and supplying high-quality, cost-effective Active Pharmaceutical Ingredients (APIs). The subsidiary positions itself as a "Partner of Choice" in the Contract Development and Manufacturing Operations (CDMO) space for drug substances.

Lupin's Global Presence

Lupin Limited, headquartered in Mumbai, India, has a significant global presence with products distributed in over 100 markets. The company is known for its pharmaceutical products, including:

• Branded and generic formulations
• Complex generics
• Biotechnology products
• Active pharmaceutical ingredients

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 23,000 professionals. The company maintains a strong position in India and the U.S. across multiple therapy areas, including:

• Respiratory
• Cardiovascular
• Anti-diabetic
• Anti-infective
• Gastrointestinal
• Central nervous system
• Women's health

This latest certification for the Dabhasa API facility underscores Lupin's ongoing commitment to quality and compliance in its global operations, potentially strengthening its position in the international pharmaceutical market.

Lupin Limited , a leading global pharmaceutical company, has announced the introduction of Loteprednol Etabonate Ophthalmic Suspension, 0.5% in the United States market. This new eye medication broadens Lupin's offerings in the country's pharmaceutical landscape.

Product Details

Loteprednol Etabonate Ophthalmic Suspension, 0.5% is an eye medication now available for patients in the United States. The launch of this product demonstrates Lupin's commitment to expanding its pharmaceutical portfolio and addressing various medical needs in the U.S. market.

Market Expansion

This latest addition to Lupin's U.S. product line underscores the company's ongoing efforts to strengthen its presence in one of the world's largest pharmaceutical markets. By introducing new medications, Lupin aims to provide healthcare professionals and patients with a wider range of treatment options.

Company's Growth Strategy

The launch of Loteprednol Etabonate Ophthalmic Suspension aligns with Lupin's strategy to diversify its product offerings and drive growth in key markets. This move is expected to contribute to the company's revenue stream and market share in the United States.

Looking Ahead

As Lupin continues to expand its pharmaceutical offerings in the U.S., the company is likely to focus on bringing more innovative and essential medications to the market. This launch serves as another step in Lupin's journey to become a prominent player in the global pharmaceutical industry.

Investors and industry observers will be watching closely to see how this new product performs in the competitive U.S. pharmaceutical market and its potential impact on Lupin's overall business performance.