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Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablet

The Deflazacort Tablets has an estimated market size of $67 million.

Pharmaceutical major Aurobindo Pharma Limited, on 12 February, announced that they have received approval from the USFDA (United States Food and Drug Administration) for Deflazacort Tablets.

In its regulatory filing, the company said that USFDA received approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg, which are used for the treatment of Duchenne muscular dystrophy (DMD) in patients who are 5 years and older.

According to PTC Therapeutics Inc, the Deflazacort Tablets has an estimated market size of $67 million for the three months ending September 2023,

The company now has a total of 502 ANAD (abbreviated new drug application), which includes 20 tentative approvals from the USFDA. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies, including USFDA, EDQM, UK MHRA, WHO, Japan PMDA, South Africa MCC, Health Canada, and Brazil ANVISA.

The headquarters of the company is located in Hyderabad and is in the business of developing, manufacturing, and commercialising a wide range of generic pharmaceuticals, active pharmaceutical ingredients (APIs), and branded speciality pharmaceuticals globally in over 150 countries.

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