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One of the units of pharma major Dr Reddy’s Laboratories Ltd has attracted four observations from the US Food and Drug Administration (USFDA).
“The audit of our Active Pharmaceutical Ingredients (API) Hyderabad plant 1 at Jinnaram Mandal, Medak District, Telangana, by the USFDA has been completed today,’’ the Hyderabad-based company has informed the BSE on Friday.
“We have been issued a Form 483 with our four observations which will be addressed comprehensively within stipulated time,’’ it said.
The nature of observations, however, has not been mentioned.
Allergy drugs in US
Dr Reddy’s Laboratories Ltd has launched Levocetirizine Dihydrochloride tablets, an over-the-counter therapeutic equivalent generic version of Xyzal Allergy 24HR tablets, in the US market. Xyzal is a registered trademark of UCB group of companies.
Levocetirizine Dihydrochloride tablets is an OTC antihistamine used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing.
“This first-to-market launch for the store brand is the testament to the deep capabilities of our store brand OTC business,” Milan Kalawadia, Vice-President and Head, US Over-the-Counter and Speciality Rx businesses, Dr Reddy’s Laboratories, said in a release issued here on Friday.
“We look forward to collaborating with our customers to bring high-quality, affordable store brand alternatives to the market.”
The Xyzal Allergy 24HR Tablets brand had US sales of approximately $71 million for the most recent 12 months ending in January 2018, according to IRI.
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