FDC Limited has secured a significant regulatory milestone with the United States Food and Drug Administration (U.S. FDA) granting Abbreviated New Drug Application (ANDA) approval for its Fluconazole Tablets USP. The approval encompasses multiple strength formulations, marking an important expansion of the company's pharmaceutical portfolio in the US market.

FDA Approval Details

The regulatory approval covers Fluconazole Tablets USP in four distinct strengths, providing comprehensive dosage options for healthcare providers and patients. The approved formulations demonstrate FDC's manufacturing capabilities and adherence to stringent FDA quality standards.

Regulatory Compliance

FDC Limited communicated this development to both major Indian stock exchanges as part of its regulatory disclosure obligations. The company filed the intimation under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, ensuring transparency with stakeholders and investors.

The announcement was formally signed by Varsharani Katre, Company Secretary & Legal Head, and submitted to BSE Limited and National Stock Exchange of India Ltd. This regulatory approval represents FDC's continued commitment to expanding its presence in international pharmaceutical markets through quality generic drug formulations.

Market Implications

Fluconazole is an important antifungal medication used to treat various fungal infections. The FDA approval for multiple strength formulations positions FDC to serve diverse patient needs in the US pharmaceutical market. The ANDA approval pathway allows the company to market generic versions of the drug, potentially capturing market share in this therapeutic segment.

This regulatory milestone reflects FDC's manufacturing excellence and regulatory compliance capabilities, essential factors for success in the highly regulated US pharmaceutical market. The approval adds to the company's growing portfolio of FDA-approved products and strengthens its position as a reliable supplier of quality generic medications.

FDC Limited has received a GST demand notice from the Maharashtra State Tax Department, totaling ₹15.61 crores for alleged tax misclassification during FY 2021-22. The pharmaceutical company disclosed this development through a regulatory filing under Regulation 30 of SEBI Listing Regulations.

GST Demand Details

The Deputy Commissioner of State Tax, Kalbadevi, Mumbai issued the demand notice under Section 73(9) of CGST/MGST Act 2017. The comprehensive demand breakdown is presented below:

Nature of Alleged Violation

The GST authorities have identified a tax rate misclassification issue spanning FY 2021-22. According to the demand notice, FDC Limited allegedly charged 18% GST on certain products instead of the applicable higher rate of 28%. The correct tax structure should have included:

• CGST: 14%
• SGST: 14%
• Compensation Cess: 12%
• Total Rate: 28%

This misclassification resulted in the differential tax demand along with accumulated interest and penalties as per GST regulations.

Company's Response

FDC Limited has indicated it is currently reviewing the order in detail and plans to pursue appropriate legal remedies to contest the demand. The company has stated that it does not anticipate any material financial impact arising from this GST demand notice.

Regulatory Compliance

The disclosure was made in accordance with SEBI regulations, ensuring transparency with stakeholders regarding this regulatory development. FDC Limited received the demand notice and informed the stock exchanges as required under listing obligations.