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Brinks Report > Blog > Health and Wellness > Zydus Lifesciences Gets USFDA Approval for Deflazacort Tablets to Treat Duchenne Muscular Dystrophy
Health and Wellness

Zydus Lifesciences Gets USFDA Approval for Deflazacort Tablets to Treat Duchenne Muscular Dystrophy

Ankita Das
Last updated: April 12, 2025 11:23 am
Ankita Das
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Zydus lifesciences gets usfda approval for deflazacort tablets to treat duchenne muscular dystrophy
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Zydus Lifesciences has received approval from the USFDA (United States Food and Drug Administration) for its Deflazacort tablets. These tablets are used to treat Duchenne muscular dystrophy (DMD) in patients aged 5 years and above. This product is a generic version of Emflaza tablets.

The tablets, branded as Jaythari, will be made at Zydus’s manufacturing facility in Italy, operated by Doppel Farmaceutici S.r.l.

Trulli

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

In a separate update, Zydus Lifesciences has formed a new company in France called Zydus MedTech (France) SAS. This was done through its Indian arm, Zydus MedTech. The new company will support Zydus’s acquisition of Amplitude Surgical SA, a France-based medical device firm.

Earlier, on 11 March 2025, Zydus had shared its plan to buy an 85.6% controlling stake in Amplitude Surgical at 6.25 euros per share, with a total value of 256.8 million euros.

Read More: New Hope for Cancer Patients! Zydus Lifesciences’ Apalutamide Tablets Approved by USFDA

Once this deal is done, Zydus will offer to buy the remaining shares at the same price. If successful, it plans to remove the company from the stock market after buying out the minority shareholders.

Zydus MedTech (France) SAS was officially formed on 10 April 2025 with an authorized share capital of 1,000 euros and a paid-up share capital of 100 euros. The company hasn’t started its business yet.

The entire ownership of this French company lies with Zydus MedTech, making it a wholly owned step-down subsidiary of Zydus Lifesciences. The investment was made fully in cash.

Zydus Lifesciences is a research-focused global company that makes and sells a wide range of healthcare products.

In financial news, Zydus reported a strong 29.62% growth in net profit, earning Rs 1,023.5 crore in Q3 FY25, compared to Rs 789.6 crore in Q3 FY24. The company’s revenue from operations also rose by 17.95% year-on-year to Rs 5,123.50 crore during the quarter.

 

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TAGGED:Deflazacort TabletsDuchenne Muscular DystrophyGeneric Drugspharma newsUSFDA ApprovalZydus Lifesciences
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