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Lupin gets USFDA’s tentative approval for Sugammadex Injection

31 Mar 2026 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial.

The USFDA has tentatively approved Lupin’s Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial as bioequivalent to Merck’s Bridion Injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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Company Name CMP
Sun Pharma. Inds. 1860.00
Dr. Reddys Labs. 1250.00
Cipla 1383.00
Lupin 2060.00
Zydus Lifesciences 1195.20
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