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USFDA IMPORT ALERT
USFDA gives exception to Glenmark Pharma to supply pneumonia drug from Baddi facilityIn a regulatory filing, Glenmark said, "...due to medical necessity and potential drug shortage expectations, the USFDA has provided an exc...- Divi's Labs Q1 net dips 41.50 per cent at Rs 177 croreStandalone total revenue from operations stood at Rs 850.88 crore for the quarter under review. It was Rs 1,033.50 crore for the same perio...
- USFDA to lift import alert on Visakhapatnam unit: Divi's LabsDivi's Laboratories has been informed by the USFDA that it will lift the Import Alert 99-32 imposed on the company's Unit-II at Visakhapatn...
- Divi's Labs climbs 3% on minimal impact of USFDA alert on Visakhapatnam unitThe company has initiated necessary measures to address the concerns raised by the US-FDA and is making all efforts to fully meet the compl...
- USFDA completes Waluj facility inspection: WockhardtWockhardt, which has been under the USFDA's scanner, today said that the American health regulator has completed the inspection of its Walu...
- Wockhardt surges 11% as USFDA completes inspection in two Maharashtra plantsWockhardt Ltd closed the day on BSE at Rs 1,575.05; up 10.67%. The stock surged as much as 11.57 per cent in intraday trade after reports t...
- Wockhardt recalls 13 drugs in US made at 2 units in MaharashtraWhen contacted, Wockhardt Chairman Habil Khorakiwala said the total number of drugs that are recalled in the US is 13.
- Wockhardt to recall some drugs made in India after US FDA concernsThe FDA banned US exports from Wockhardt's Waluj and Chikalthana plants in central India in 2013, citing manufacturing quality lapses.
- IPCA Labs plunges over 11% on USFDA alertIPCA Laboratories plunged over 11%in trade following reports that it has received US FDA import alert at two manufacturing facilities.
- Should investors buy Ipca Labs after US import alert?It can take anywhere between 15-20 months for the company to resolve the issue. The USFDA had issued Form 483 to Ratlam API in mid 2014.
- IPCA Labs slips over 8% on USFDA import alert for Ratlam plantFDA had issued Form 483 to Ratlam API in mid 2014. In form 483s, FDA pointed out data integrity issues at Ratlam plant.
- Why multibagger Wockhardt is on analysts' 'sell' radar nowFundamental troubles or the regulatory problems are not going to go away in a hurry for Wockhardt and it has become more of a trading stock...
- Brokerages lower Wockhardt's target price after USFDA import alert on Chikalthana plantThe USFDA import alert on Wockhardt's second plant will have a negative impact on the pharma major, say brokerages.
- Wockhardt extends overnight losses post import alertShares of Wockhardt extended losses for second consecutive session as sentiment turned bearish in the counter after the USFDA issued import...
- Wockhardt's Chikalthana plant hit by USFDA import restrictionsIn May, the USFDA had also issued an import alert on the company's Waluj facility which makes injectables and solid dosages.
- Ranbaxy dives over 30%; m-cap down by Rs 5,855 crore on USFDA import alertA massive sell-off in the stock sent the company's market value down by Rs 5,855 crore to Rs 13,491 crore.
- USFDA scrutiny: Will pharma majors like Ranbaxy, Wockhardt be affected in long-term?Manufacturing-related indiscretions of Indian firms put a question mark on prospects for generics exports.
- USFDA lifts import alert on Aurobindo Pharma's Hyderabad facilityUSFDA has lifted the import alert for non-sterile products manufactured at Unit-VI cephalosporin facility based in Hyderabad.
- Aurobindo Pharma receives warning letter from USFDA; stock over 9 pc downAurobindo Pharma said it has received a warning letter from the USFDA with regard to its antibiotics manufacturing unit in Hyderabad.
- Aurobindo to suffer $2-mn loss per month due to USFDA banAurobindo Pharma said they may incur a revenue loss to the extent of $2 million per month till the issue remains unresolved.
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