Alembic Pharmaceuticals has filed writ petitions with the Gujarat High Court challenging supplementary invoices worth ₹421.68 crores issued by Madhya Gujarat Vij Company Limited (MGVCL). The pharmaceutical company disclosed this legal action under Regulation 30 of SEBI Listing Regulations.

Legal Challenge Details

Alembic Pharmaceuticals has approached the High Court of Gujarat, Ahmedabad, seeking to quash and set aside the disputed supplementary invoices related to the installation of rooftop solar PV system. The legal action represents a significant dispute between the pharmaceutical manufacturer and the Gujarat state electricity distribution company.

Financial Implications

The company has clarified that the financial implications of this litigation will depend entirely on the final outcome of the court proceedings. Currently, there is no immediate financial liability pending the resolution of the matter. The disputed amount of ₹421.68 crores represents a substantial sum that could impact the company's financials depending on the court's decision.

Regulatory Compliance

Alembic Pharmaceuticals made this disclosure in compliance with SEBI regulations, specifically under Regulation 30 of the Listing Obligations and Disclosure Requirements Regulations, 2015. The company provided detailed information as required under Schedule III of the Listing Regulations.

Current Status

The matter remains sub-judice with the Gujarat High Court. The company has emphasized that the invoiced amount is disputed, and the final monetary impact will only be determined once the litigation is conclusively resolved. This legal challenge highlights ongoing disputes in the renewable energy sector, particularly regarding billing and installation charges for solar power systems.

Alembic Pharmaceuticals Limited has achieved a significant milestone in its pharmaceutical journey by receiving final approval from the US Food & Drug Administration (USFDA) for its Dexlansoprazole Delayed-Release Capsules in 30 mg and 60 mg strengths. This development marks a crucial step for the company in expanding its presence in the US pharmaceutical market.

Key Highlights

• Product Approval: Alembic Pharmaceuticals has received USFDA final approval for Dexlansoprazole Delayed-Release Capsules.
• Market Potential: The approved product has an estimated market size of $285 million.
• Therapeutic Use: Dexlansoprazole is a proton pump inhibitor (PPI) used for treating various gastrointestinal conditions.
• Target Age Group: The medication is indicated for patients 12 years of age and older.

Product Details

Dexlansoprazole Delayed-Release Capsules are therapeutically equivalent to Takeda Pharmaceuticals USA, Inc.'s Dexilant Delayed-Release Capsules. The medication is primarily used for:

1. Healing of all grades of erosive esophagitis (EE)
2. Maintenance of healed EE and relief of heartburn
3. Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD)

Market Impact

The approval of Dexlansoprazole Delayed-Release Capsules opens up a significant market opportunity for Alembic Pharmaceuticals. According to IQVIA data, the estimated market size for this product is $285.00 million for the twelve months ending September 2025.

Alembic's ANDA Approvals

This latest approval adds to Alembic's impressive track record with the USFDA:

Company Background

Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company. The company specializes in manufacturing and marketing generic pharmaceutical products globally. With state-of-the-art research and manufacturing facilities approved by regulatory authorities of many developed countries, including the USFDA, Alembic has positioned itself as a leader in branded generics in India.

This latest USFDA approval for Dexlansoprazole Delayed-Release Capsules not only enhances Alembic's product portfolio but also strengthens its position in the competitive US pharmaceutical market. The significant market size of the approved product suggests potential for substantial revenue generation, subject to successful commercialization and market penetration strategies.