Shilpa Medicare Limited, a prominent pharmaceutical company, has received approval from the National Stock Exchange (NSE) for the reclassification of two promoter group shareholders to the public category. This strategic move involves a significant 4.09% of the company's shareholding structure.

Reclassification Details

The reclassification approval, granted under Regulation 31A of SEBI (LODR) Regulations, 2015, pertains to two key individuals:

1. Suraj Kumar Inani: Holding 39,20,695 shares (4.01% of total shareholding)
2. Priya Inani: Holding 80,696 shares (0.08% of total shareholding)

In total, the reclassification encompasses 40,01,391 shares, representing 4.09% of Shilpa Medicare's shareholding structure.

Approval Process and Timeline

The company had submitted the reclassification application to both the National Stock Exchange of India Limited and BSE Limited on August 13. The NSE approval, detailed in letter No. NSE/LIST/COMP/SHILPAMED/508, was received on September 26.

Implications and Compliance

This reclassification marks a significant change in Shilpa Medicare's shareholding pattern. The company is required to ensure compliance with subsequent relevant disclosures of material events related to this reclassification, as per the applicable provisions of Regulation 31A of SEBI (LODR) Regulations, 2015.

Additional Corporate Update

In a separate announcement, Shilpa Medicare has also informed about the closure of its trading window. The trading window for dealing in the company's securities will remain closed for all designated persons, their immediate relatives, and connected persons from October 1. This closure will continue until 48 hours after the declaration of unaudited financial results for the quarter and half-year ending September 30.

Shilpa Medicare Limited, with its corporate office in Raichur, Karnataka, continues to navigate regulatory requirements while maintaining transparency with its shareholders and the market at large.

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.