Dr Reddy's Laboratories Saturday announced the launch of Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules, a therapeutic equivalent generic version of Vitamin K1, in the US market.
"We're pleased to bring this product to market for the customers and patients who will benefit from access to this medicine and who have in the past experienced supply disruptions in the market place," said Marc Kikuchi, CEO, North America Generics, Dr Reddy's Laboratories.
The Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10 mg/ml brand and generic, had combined US sales of approximately USD 46.6 million MAT for the most recent twelve months ended April 2019 according to IQVIA Health, Dr Reddy's said in a statement.
Dr Reddy's Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules is available in 1 ml Ampule containing 10 mg/ml of Phytonadione.
In a separate regulatory filing, the company said the audit of its Formulations Manufacturing Plants (Vizag SEZ Plant 1 and Vizag SEZ Plant 2) at Duvvada, Visakhapatnam by the USFDA, has been completed on June 21 and it has been issued a Form 483 with 2 observations.
"We will address them comprehensively within the stipulated timeline," Dr Reddy's Laboratories said.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.