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Zydus Life gets USFDA nod for Deflazacort tablets to treat Duchenne muscular dystrophy

12-Apr-25 10:22 Hrs IST

The product is the generic equivalent of Emflaza tablets, and is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 5 years and older.

Jaythari will be manufactured at the group's Doppel Farmaceutici S.r.l. facility in Italy.

With this approval, Zydus has now amassed 424 final ANDA (Abbreviated New Drug Application) approvals from the USFDA. The company has filed a total of 492 ANDAs since it began the process in FY 2003-04.

Separately, Zydus Lifesciences announced the incorporation of a wholly owned subsidiary in France, named Zydus MedTech (France) SAS, through its Indian arm Zydus MedTech. The move is a strategic step in Zydus's ongoing acquisition of Amplitude Surgical SA, a France-based medical device company.

This development follows Zydus's earlier disclosure on 11 March 2025, regarding its agreement to acquire an 85.6% controlling stake in Amplitude Surgical SA via a Block Acquisition, at a price of 6.25 euros per share, totaling a consideration of 256.8 million euros.

Upon the successful completion of this block transaction, Zydus intends to launch a mandatory cash tender offer for the remaining shares of Amplitude Surgical at the same price. If conditions are met, the company plans to proceed with a squeeze-out of minority shareholders and subsequently delist the target entity.

To facilitate this transaction, Zydus MedTech (France) SAS was incorporated on 10 April 2025, with an authorized share capital of 1,000 euros and a paid-up share capital of 100 euros. As of now, the company has not commenced business operations.

The entire shareholding of the new French subsidiary is held by Zydus MedTech, making it a wholly owned step-down subsidiary of Zydus Lifesciences. The investment was made in cash, including a share capital contribution and an issuance premium.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 17.95% YoY to Rs 5,123.50 crore during the quarter.