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The USFDA had inspected company's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa, between August 31 and September 4, 2016 and issued six observations in Form 483.
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Typically, the US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly
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The US drug regulator issued the observations for its oncology formulation facility at Duvvuda in Visakhapatnam‘s SEZ. The site is important given Dr Reddy‘s focus on complex generic filings.
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The Duvvada site manufactures cytotoxic and hormonal injectables and is an important plant given Dr Reddy‘s focus on complex generic filings. The Unit-7 received had warning letter in November 2015.
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Glenmark Pharmaceuticals today said it has received four observations from the US health regulator for its Ankleshwar facility after inspection in December 2016.
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Having lost one-third of its value in two trading days, Divi's now trades at a discount to its peers. Apart from reducing its expected earnings analysts have also reduced the company's price to earnings ratio, reflecting the fall in grace
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In an interview to CNBC-TV18, Arun Kumar, Founder & MD of Strides Shasun says that the pharma industry lacks trust now as more and more issues with regulators come to light.
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A facility of biopharmaceuticals firm Biocon has cleared inspection by the US FDA
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US FDA has issued a Form 483 to Wockhardt making certain observations with respect to manufacturing practices at its Shendra unit. The following are the observations.
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Habil Khorakiwala, chairman, Wockhardt Ltd addressed the media after the US health regulator said it did not find any issues with respect to data security and control measures at Chikalthana plant in a recent inspection.
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The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement, without giving details.
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Arvind Bothra of Religare Capital Markets doesn't see US FDA action against Ipca translating into a similar action by European or other regulators because they have definitely different norms etc.
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According to the Credit Suisse, Form 483 for the Indore SEZ suggests Food and Drug Administration (FDA) observations are critical and could delay recovery of US sales.
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Import alert issued by USFDA on Ranbaxy's Mohali plant could not only be negative for the stock but according to the analyst community Ranbaxy could be on its last legs for having a good strong base in the US.
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The stock hit a near 4-year low after a news report said the US FDA may have issued a form 483 to its Mohali facility. The company has already pleaded guilty to felony charges related to manufacturing practises at its Dewas and Paonta Sahib plants.
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Business Standard said the FDA had issued form 483 to Ranbaxy regarding its Mohali plant. That form is issued when U.S. inspectors see conditions they believe may violate US rules.
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The US drug regulator has issued an import alert on Wockhardt's facility at Aurangabad in Maharashtra. The stock closed down 20 percent, its lower circuit level, at Rs 1,313.80 on NSE.
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Citigroup Global Markets maintained its "buy" rating on pharma major Wockhardt, saying recent plant inspection and subsequent observations raised by US Food and Drug Administration wouldn't have any immediate impact on the co's business.
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Pharma major Wockhardt slumped 10 percent on Friday on reports that the US Food and Drugs Administration had issued a 483 form through a routine course of inspection of one of its plants. The inspection was for its injectables facility in Aurangabad.
