The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
None of the observations are related to data integrity and management believes that they are addressable
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition
Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States
Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
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