Zydus Lifesciences secures FDA nod for high-demand Sugammadex Injection

Zydus Lifesciences Limited, a formidable name in the pharmaceutical realm, proudly announces its final endorsement from the United States Food and Drug Administration (USFDA) for its Sugammadex Injection variants – 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial. This significant stamp of approval propels Zydus into the spotlight in the US market, giving it an edge with a product synonymous with the recognized USRLD: Bridion Injection.

Inside Sugammadex Injection: Medical Marvel for Neuromuscular Blockade Reversal

Designed with precision and efficacy, the Sugammadex Injection serves as a potent solution to counteract neuromuscular blockades brought on by rocuronium bromide and vecuronium bromide in adults who are under surgical procedures. This state-of-the-art injection will be produced at Zydus’s state-of-the-art injectable manufacturing hub located in Jarod, in proximity to Vadodara, India. Notably, the Sugammadex Injection, with its 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) specifications, has previously demonstrated a robust performance in the US, registering staggering annual sales to the tune of USD 986 million, as per IQVIA MAT Aug 2023 data.

Zydus’s Legacy: A Journey of Approvals and Achievements

The recent USFDA approval fortifies Zydus Lifesciences Limited’s already illustrious journey in the pharmaceutical sector. The company boasts an impressive 381 approvals to its name. Since the onset of its filing endeavors in the fiscal year 2003-04, Zydus has showcased commendable consistency, having submitted over 444 ANDAs (Abbreviated New Drug Applications). This Sugammadex Injection approval serves as another testament to Zydus’s commitment to healthcare excellence and innovation.