Jubilant Pharmova Limited 's subsidiary, Jubilant Generics Limited, has received tentative approval from the United States Food and Drug Administration (USFDA) for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet. This regulatory milestone follows the successful completion of a pre-approval inspection (PAI) conducted by the USFDA at the company's Solid Dosage Manufacturing Facility in Roorkee. The development positions the company to enter the US market upon the expiry of the relevant patent.

Approval Details

The key parameters of the tentative approval are summarised below:

The tentative approval is subject to the expiry of the patent covering the currently listed Reference Listed Drug (RLD). The patent is expected to expire in December 2026, after which final approval for the product is anticipated to be granted, enabling a commercial launch in the US market.

Regulatory Disclosure

The disclosure was made to the stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company confirmed that the information was received on June 25, 2026, at 11:47 am. Jubilant Generics Limited is a subsidiary of Jubilant Pharma Limited, which is a wholly-owned subsidiary of Jubilant Pharmova Limited.

Jubilant Pharmova Limited announced that its wholly-owned step-down subsidiary, Jubilant Generics Limited, has received a rectification order from the Income Tax Department. The order, dated June 23, 2026, concerns the income assessed for Assessment Year 2023-24 and provides a significant reduction in the tax adjustments previously demanded.

Pursuant to the rectification application filed by Jubilant Generics Limited, the tax adjustments have been reduced from Rs. 107.89 crs to Rs. 42.41 crs. This development restores tax losses amounting to Rs. 65.48 crs for the subsidiary. The relief was granted by the relevant Transfer Pricing Officer following the submission of the application.

The company disclosed that the order was received on June 23, 2026, at 10:17 PM IST. Despite this relief, Jubilant Pharmova clarified that the appeal on merit grounds regarding the matter is being pursued before the Commissioner of Income Tax (Appeals) separately.

The following table outlines the key financial changes resulting from the rectification order:

The disclosure was made to the stock exchanges in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The information was submitted by Naresh Kapoor, Company Secretary of Jubilant Pharmova Limited.