Indoco Remedies , a prominent player in the pharmaceutical industry, has achieved a significant milestone in its expansion into the U.S. market. 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 Rivaroxaban tablets.

Key Highlights

• Indoco Remedies has obtained USFDA approval for Rivaroxaban tablets in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg.
• The approved generic is bioequivalent and therapeutically equivalent to Janssen Pharmaceuticals' Xarelto tablets.
• Rivaroxaban is primarily used for the treatment of venous thromboembolism (VTE).
• The tablets will be manufactured at Indoco's facility in Verna, Goa.

Strategic Importance

This regulatory approval marks a crucial step for Indoco Remedies, allowing the company to manufacture and market the generic version of Rivaroxaban in the United States. The move is expected to strengthen Indoco's position in the competitive U.S. pharmaceutical market.

Ms. Aditi Panandikar, Managing Director of Indoco Remedies, commented on the achievement, stating, "Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US."

About Indoco Remedies

Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a strong global presence. Key facts about the company include:

• Annual turnover of approximately US$ 180.00 million
• Workforce of over 6,000 employees, including more than 400 skilled scientists
• 11 manufacturing facilities (7 for finished dosage forms and 4 for active pharmaceutical ingredients)
• State-of-the-art R&D Center and CRO facility
• Approvals from major regulatory authorities, including USFDA and UK-MHRA
• 10 domestic marketing divisions with a strong brand portfolio in various therapeutic segments
• International partnerships with large generic companies globally

The approval of Rivaroxaban tablets adds to Indoco's growing portfolio of FDA-approved products and underscores the company's commitment to expanding its presence in the U.S. generic drug market. This development is expected to contribute positively to Indoco Remedies' growth trajectory in the coming years.

Indoco Remedies , a prominent pharmaceutical company, has reported a significant inter-group share transfer among its promoter group members. The transaction, which took place on August 7-8, 2025, involved the acquisition and sale of 28,100 equity shares, maintaining the overall promoter group holding.

Key Transaction Details

• Acquirers:

  • Aditi M. Panandikar purchased 20,800 shares
  • Madhura S. Kare acquired 7,300 shares

• Sellers:

  • Megh M. Panandikar sold 13,000 shares
  • Mahika M. Panandikar sold 7,800 shares
  • Rohan A. Ramani sold 7,300 shares

Impact on Shareholding

The inter-group transfer resulted in changes to individual promoter holdings:

Despite these individual changes, the combined promoter group holding remained constant at 1,09,31,545 shares, representing 11.85% of Indoco Remedies' total equity capital.

Transaction Details

• The shares were acquired through open market purchases.
• Aditi M. Panandikar's purchase of 20,800 shares occurred on August 7, 2025.
• Madhura S. Kare's acquisition of 7,300 shares took place on August 8, 2025.
• The sellers (Megh M. Panandikar, Mahika M. Panandikar, and Rohan A. Ramani) disposed of their shares on August 7, 2025.

Company Share Capital

Indoco Remedies' share capital structure remains unchanged:

• Total equity shares: 9,22,47,905
• Face value per share: Rs. 2
• Total share capital: Rs. 18,44,95,810

The company has duly filed the required disclosures under Regulation 29(2) of SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 2011, ensuring transparency in the share transfer process.

This inter-group transfer among promoter members indicates a realignment of ownership within the promoter group, while maintaining their overall stake in the company. Such transactions are common in family-owned businesses and do not affect the company's operations or public shareholding pattern.