Jubilant Pharmova has announced that its subsidiary, Jubilant Generics, has received tentative approval from the US Food and Drug Administration (USFDA) for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.
Jubilant Generics is a subsidiary of Jubilant Pharma, which is a wholly owned subsidiary of Jubilant Pharmova.
The tentative approval is subject to the expiry of the patent protecting the currently listed Reference Listed Drug (RLD), which is expected to expire in December 2026. The company expects to receive final USFDA approval after the patent expires, enabling commercial launch of the product in the US market.
The development further expands Jubilant Generics' portfolio of products approved for the US market and supports the company's strategy of strengthening its presence in the global generics business.
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