Indoco Remedies has announced a significant milestone in its regulatory compliance efforts. The company's Active Pharmaceutical Ingredients (API) manufacturing facility at Patalganga, Navi Mumbai, has successfully passed a United States Food and Drug Administration (USFDA) inspection with zero observations.

Inspection Outcome

The USFDA completed its inspection of the Patalganga API manufacturing facility without issuing any Form 483 observations. This outcome is a strong indication of the facility's adherence to good manufacturing practices and regulatory standards set by the US drug regulator.

Management's Perspective

Ms. Aditi Panandikar, Managing Director of Indoco Remedies, expressed her satisfaction with the inspection results. She stated, "This successful USFDA inspection is a testament to the strong quality culture and compliance in every process and every product. We remain committed to strengthening our systems to deliver safe and efficacious medicines across the globe."

Company Profile

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

• Annual turnover of US$ 180.00 million
• Workforce of over 6,000 employees, including more than 400 skilled scientists and field staff
• 11 manufacturing facilities (7 for Finished Dosage Forms and 4 for APIs)
• State-of-the-art R&D Centre and a CRO facility
• Facilities approved by major regulatory authorities, including USFDA and UK-MHRA

Market Presence

Indoco Remedies has a strong presence in both domestic and international markets:

• 10 domestic marketing divisions
• Generates over 106 million prescriptions annually from more than 240,000 doctors
• Strong brand portfolio across various therapeutic segments
• International tie-ups with large generic companies globally

Implications

The successful completion of the USFDA inspection without any observations is a significant achievement for Indoco Remedies. It underscores the company's commitment to maintaining high-quality standards and regulatory compliance in its API manufacturing processes. This outcome is likely to bolster confidence among Indoco Remedies' partners, customers, and stakeholders, potentially opening doors for expanded opportunities in the highly regulated US pharmaceutical market.

For investors and industry observers, this development signals Indoco Remedies' capability to meet stringent international quality standards, which is crucial for success in the global pharmaceutical industry, especially in lucrative markets like the United States.

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.