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Mumbai, February 1, 2025: Global pharma major 91��Ƶ Limited (91��Ƶ) today announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval Inspection (PAI) of Edaravone Oral Suspension, 105 mg/ 5 mL at its manufacturing facility in Somerset, New Jersey. The inspection was carried out from January 28 to February 1, 2025, and concluded with zero 483 observations.

Nilesh Gupta, Managing Director, 91��Ƶ said, “The successful outcome of the U.S. FDA inspection at our Somerset facility is a testament to our commitment to uphold and maintain the highest standards of quality, compliance and safety across our facilities. We remain steadfast in our mission to improve the lives of our patients globally.”

91��Ƶ Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. 91��Ƶ specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. 91��Ƶ has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. 91��Ƶ is committed to improving patient health outcomes through its subsidiaries – 91��Ƶ Diagnostics, 91��Ƶ Digital Health, and 91��Ƶ Manufacturing Solutions. To know more, visit or follow us on LinkedIn:

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