Shilpa Medicare Limited has announced the US launch of BORUZU™ (Bortezomib for Injection 3.5mg/1.4ml) in partnership with Amneal Pharmaceuticals. The product is a ready-to-use formulation designed for subcutaneous or intravenous (IV) administration, reducing preparation steps typically required for oncology treatments.

The launch of BORUZU™ marks Shilpa Medicare’s second NDA product in the US market, reflecting the company’s advancements in novel injectable formulations and its commitment to improving pharmaceutical efficiency.

About BORUZU™ (Bortezomib for Injection)

BORUZU™ is a proteasome inhibitor used in the treatment of multiple myeloma and mantle cell lymphoma. It is an alternative to Velcade®, which requires reconstitution before administration. The ready-to-use formulation of BORUZU™ simplifies the process, reducing preparation time and improving pharmacy efficiency.

Key highlights of BORUZU™:

• Indications: Approved for multiple myeloma and mantle cell lymphoma treatment.

• Formulation: Available as a ready-to-use injectable, eliminating the need for compounding steps.

• CMS Approval: The U.S. Centers for Medicare & Medicaid Services (CMS) has granted a permanent J-code, facilitating reimbursement under Medicare and Medicaid programs.

• Manufacturing & Commercialization: Shilpa Medicare developed the molecule, while Amneal Pharmaceuticals will manufacture and commercialize the product in the US market.

Strategic Significance for Shilpa Medicare

The launch of BORUZU™ underscores Shilpa Medicare’s growing footprint in the US pharmaceutical market. According to Managing Director Vishnukant Bhutada, this milestone reflects Shilpa’s capabilities in pharmaceutical innovation and its dedication to introducing first-of-its-kind pharmaceutical solutions.

"This is the second NDA product being launched in the US market from our novel injectable portfolio. It demonstrates our commitment to introducing pharmacy-efficient solutions that enhance compliance and reduce patient wait times. Our goal is to continue innovating and meeting the healthcare needs of a large patient base," said Bhutada.

Shilpa Medicare’s Expanding Portfolio

Shilpa Medicare has built a strong presence in the oncology and non-oncology pharmaceutical sector with a focus on:

• Active Pharmaceutical Ingredients (APIs)

• Peptides and Polymers

• Differentiated Finished Dosage Forms (including novel injectables, orally dispersible films, and transdermal patches)

• Biological Portfolio and CDMO Services

The company operates four R&D centers and seven manufacturing facilities, driving innovation across multiple therapeutic areas.

Impact on the US Oncology Market

The US oncology drug market is one of the largest in the world, with increasing demand for efficient and patient-friendly treatment options. The introduction of ready-to-use Bortezomib aligns with industry trends focusing on reducing preparation time and improving patient accessibility.

With Amneal Pharmaceuticals leading commercialization, BORUZU™ is expected to capture a significant share in the oncology market, especially among healthcare providers looking for simplified treatment options.

Conclusion

The launch of BORUZU™ (Bortezomib Injection) in the US marks another strategic milestone for Shilpa Medicare, reinforcing its commitment to pharmaceutical innovation and oncology treatment advancements. By offering a ready-to-use formulation with CMS reimbursement approval, the product aims to improve treatment accessibility, efficiency, and patient outcomes.

With a strong pipeline of novel pharmaceutical solutions, Shilpa Medicare is well-positioned to expand its presence in the global pharmaceutical industry, particularly in the US market.

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