Shilpa Medicare Limited , a prominent Indian pharmaceutical company, has achieved a significant milestone in its European expansion strategy. The company recently received Initial Authorization from the European Medicine Agency (EMA) for its generic version of Rivaroxaban in orodispersible film form, marking a notable advancement in anticoagulant medication delivery.

Key Highlights

• Shilpa Medicare has obtained Initial Authorization for Rivaroxaban 10 mg, 15 mg, and 20 mg Orodispersible Films.
• The approval covers the company's manufacturing facility in Dabaspet, Bengaluru.
• This generic version is bioequivalent to Bayer AG's Xarelto, a widely used anticoagulant.
• Shilpa's product is the only Rivaroxaban available in orodispersible film form in Europe.

Product Details and Market Potential

Rivaroxaban is an anticoagulant medicine used to treat and prevent various blood clotting disorders, including deep vein thrombosis, pulmonary embolism, and atherothrombotic events in adults. Shilpa Medicare's innovative orodispersible film formulation is designed to enhance patient comfort, particularly benefiting geriatric patients who may have difficulty swallowing traditional tablets.

The European market for oral Rivaroxaban formulations is substantial, valued at approximately USD 2.50 billion. This presents a significant opportunity for Shilpa Medicare to capture market share with its unique delivery format.

Manufacturing and Regulatory Approval

The approved product will be manufactured at Shilpa Medicare's Unit VI facility in Dabaspet, Bengaluru, Karnataka. This state-of-the-art facility, which specializes in producing oral dispersible/dissolving films and transdermal patches, has already received approvals from the U.S. Food and Drug Administration (USFDA), European authorities, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Strategic Importance

This authorization marks the third approval of a prescription oral mouth dissolving film product in European markets from Shilpa Medicare's Bengaluru facility. It underscores the company's growing expertise in specialized dosage forms and its commitment to expanding its presence in the European pharmaceutical market.

Ritu Tiwary, Company Secretary & Compliance Officer of Shilpa Medicare Limited, confirmed the development in a regulatory filing, highlighting the strategic importance of this authorization for the company's growth in the European market.

As Shilpa Medicare Limited continues to innovate and expand its product portfolio, this latest authorization not only strengthens its position in the anticoagulant market but also demonstrates its capability to develop and manufacture complex pharmaceutical formulations for global markets.

Shilpa Medicare Limited , a prominent Indian pharmaceutical company, has announced a significant international expansion through its wholly-owned subsidiary, Koanna International FZ LLC. The company has entered into a definitive agreement with Pharma Pharmaceutical Industries & Biological Products (PPI), a leading Saudi enterprise, to establish a new joint venture in Saudi Arabia.

Joint Venture Structure and Objectives

The newly formed joint venture will see PPI holding a 70% majority stake, while Koanna International FZ LLC will retain a 30% ownership. This strategic partnership aims to establish a state-of-the-art pharmaceutical manufacturing facility in Saudi Arabia, marking a significant step in Shilpa Medicare's global expansion strategy.

Two-Phase Implementation Plan

The joint venture will be executed in two key phases:

1. Phase One: Shilpa Group will supply finished products in bulk for repackaging at the new joint venture company's facility. This approach ensures a swift market entry for key products. Concurrently, PPI will be responsible for establishing a fully-equipped manufacturing facility with technical input from Shilpa Group.

2. Phase Two: Shilpa Group will conduct a comprehensive technology transfer of its manufacturing processes to the joint venture. This will enable the local production of finished pharmaceutical products in Saudi Arabia.

Roles and Responsibilities

Under the terms of the agreement:

• Shilpa Group will provide technical support for the transfer of the project site to the joint venture company.
• PPI will be responsible for equipping the facility with all necessary infrastructure and packaging equipment to meet international standards.
• Shilpa Group will prepare the complete regulatory registration dossier in compliance with the Saudi Food and Drug Authority (SFDA) and lead the process of obtaining the necessary Market Authorization.

Strategic Implications

This joint venture represents a significant milestone for both companies:

• For Shilpa Medicare, it strengthens its global footprint and consolidates its presence in the MENA (Middle East and North Africa) region.
• For PPI, it brings world-class manufacturing technology and expertise to Saudi Arabia, accelerating its ability to meet the growing healthcare needs of the Kingdom with locally manufactured, high-quality medicines.

Alignment with Saudi Vision 2030

The partnership aligns with Saudi Arabia's Vision 2030 goals of economic diversification and localizing strategic industries. It represents a significant step in enhancing the Kingdom's healthcare infrastructure and pharmaceutical manufacturing capabilities.

Management Commentary

Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare Ltd, commented on the joint venture: "We are excited to partner with PPI. This joint venture combines PPI's unmatched local strength with Shilpa's innovative technology to improve healthcare in the Kingdom. PPI is the ideal partner to make our products more accessible. This JV underscores our commitment to Saudi Arabia and will consolidate our presence across the MENA region."

Mr. Wael B Aldahhasi, Chairman of PPI, added: "Partnering with Shilpa Group allows us to bring world-class manufacturing technology and expertise to the Kingdom. This initiative will accelerate our ability to meet the growing healthcare needs of Saudi Arabia with locally manufactured, high-quality medicines."

This strategic move by Shilpa Medicare Limited through its subsidiary Koanna International FZ LLC marks a significant step in the company's international expansion and its commitment to enhancing healthcare accessibility in the Middle East and North Africa region.