USFDA withdraws warning letter to Divi's Lab unit
Drug firm Divi's Laboratories today said the US health regulator has "closed out" a warning letter issued to a unit at Visakhapatnam following evaluation of corrective actions taken by the company at the plant.
"Divi's Laboratories has been informed by the USFDA that the agency has completed evaluation of the company's corrective actions in response to FDA's warning letter..dated April 13, 2017" the company said in a BSE filing.
"We also note from the update on FDA's website that they have closed-out the warning letter," it added.
Amazon Great Indian Festival Sale 2023 likely to begin soon; discounts, exchange and bank offers, and more
Domestic capital goods firm announces expansion plan, to venture into Dubai market with Rs 500 million investment
India vs Australia 3rd ODI Free Live Streaming: When and How to watch IND VS AUS match live on Web, tv, mobile apps online
NPS Tier II Default Scheme: Flexibility, easy withdrawals, and no minimum balance; here's what makes it a smart choice
Following the announcement, shares of the company rose by 2.80 per cent to Rs 1,038 apiece in morning session on BSE.
Last week, Divi's Laboratories had informed that the US health regulator would lift an import alert imposed on the company's Unit-II in Visakhapatnam and was moving to close out the warning letter issued to the unit.
The USFDA in March had issued import alert under clauses 99-32 and 66-40, and a warning letter later for the Visakhapatnam facility for non-compliance of good manufacturing practice (GMP) norms, the company had informed bourses earlier.
The company in July announced that USFDA had moved to lift Import Alert 99-32 imposed on the unit.
As per USFDA, an import alert under 66-40 entails "detention without physical examination" of drugs from firms which have not met drug GMPs, while alert under 99-32 is issued to "firms refusing FDA foreign establishment inspection".
(This article has not been edited by Zeebiz editorial team and is auto-generated from an agency feed.)
Get Latest Business News, Stock Market Updates and Videos; Check your tax outgo through Income Tax Calculator and save money through our Personal Finance coverage. Check Business Breaking News Live on Zee Business Twitter and Facebook. Subscribe on YouTube.
Retirement Planning: How long-term recurring deposit is a low-risk, guaranteed return investment for senior citizens?
JSW Infrastructure IPO opens for subscription: Check price band, lot size, share listing date and time on NSE, BSE
Traders' Diary: Buy, sell or hold strategy on IRCTC, LIC Housing Finance, Lemon Tree, ONGC, Tech Mahindra, over a dozen other stocks today
Dividend, stock split shares this week: HAL, Brightcom Group, Bajaj Holdings & Investment among other shares to trade ex-date
Delta Corp, Bajaj Finance, pharma companies, LIC, CEAT, and Karnataka Bank among top stocks to watch today