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"Drug Products Adulterated": US Regulator Warns Sun Pharma's Gujarat Plant
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.
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Cipla Shares Fall 6% After US Regulator's Warning Letter On Goa Facility
Cipla Share Price: Cipla said it will work closely with the US Food and Drug Administration (FDA) to comprehensively address all the observations.
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Divi's Lab Shares Pare Gains, Trade Flat After US FDA Closes Out Warning Letter
The shares of Divi's Laboratories (Divi's Lab) pared early gains to trade 0.86% higher at Rs 1,018 on BSE at 3.10 pm. The scrip had hit 8% higher
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Lupin Shares Tank 17% On USFDA's Warning Letter, Brokerages Give 'Buy' Rating
The Lupin shares crashed over 17% to trade at Rs 851 soon after it announced, in a stock filing, that it has received a warning letter issued by the USFDA pertaining to its plants located in Goa and Indore (Pithampur Unit II).
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Divi's Lab Shares Close 17% Higher As USFDA's Import Ban Set To Be Lifted From Vizag Plant
Divi's Laboratories has informed the NSE in a stock exchange filing that the USFDA will soon lift the import Alert 66-40 and will move to close out the warning letter issued to the company's unit-II at Vishakhapatnam.
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USFDA To Lift Import Alert On Visakhapatnam Unit: Divi's Labs
The company had earlier said that the USFDA had issued an import alert under clauses 99-32 and 66-40 in March, and a warning letter later for the Vishakhapatnam facility.
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USFDA issues Warning Letter To Divis Labs For Vishakhapatnam Unit
The United States Food and Drug Administration (USFDA) has issued warning letter for the company's Unit-II at Vishakhapatnam, Divis Laboratories said in a BSE filing.
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Wockhardt Plunges After US Drug Regulator Warns Subsidiary
After a weak opening, shares of the company further went down by 6.67 per cent to Rs 701 on BSE.
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USFDA Issues Warning Letter To Wockhardt's US Arm
The company, however, did not provide any details about the reasons for the issuance of warning letter and when it was issued.
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USFDA Issues Warning Letter To Wockhardt's Ankleshwar Plant
USFDA has already banned import of products from the facility into the US market since August 5, 2016.
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US Food Regulator Made 9 Observations Post Halol Unit Inspection: Sun Pharma
Sun Pharma was earlier issued a warning letter by the USFDA for its Halol facility in December 2015.
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FDA Warns Former Sun Pharma US Drug Factory Over Quality Concerns
The US Food and Drug Administration has pulled up a former Sun Pharmaceutical drug factory for "knowingly" releasing 27 lots of the hypertension drug clonidine last year, despite proof that the raw materials used may have been contaminated.
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Awaiting USFDA Response on Re-Mediation Efforts of 3 Units: Dr Reddys Lab
Dr Reddys Laboratories (DRL) is awaiting a response from USFDA for future course of action over its three plants, for which the health regulator had issued warning letter, as the drug firm has completed its comprehensive corrective and preventive action plan (CAPA).
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IPCA Labs Shares Crash on Warning Letter from USFDA
IPCA Laboratories shares crashed 16.27 per cent on Monday after the drugmaker said it has received a warning letter from US drug regulator highlighting manufacturing quality lapses at three of its units.
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Cadila Healthcare Receives FDA Warning Letter, Shares Plunge
The shares of Cadila Healthcare slipped over 15 per cent to Rs 324 as the company received a warning letter from the USFDA for two plant-- Moraiya formulation facility and Ahmedabad active pharmaceutical ingredient facility (Zyfine).
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"Drug Products Adulterated": US Regulator Warns Sun Pharma's Gujarat Plant
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.
-
Cipla Shares Fall 6% After US Regulator's Warning Letter On Goa Facility
Cipla Share Price: Cipla said it will work closely with the US Food and Drug Administration (FDA) to comprehensively address all the observations.
-
Divi's Lab Shares Pare Gains, Trade Flat After US FDA Closes Out Warning Letter
The shares of Divi's Laboratories (Divi's Lab) pared early gains to trade 0.86% higher at Rs 1,018 on BSE at 3.10 pm. The scrip had hit 8% higher
-
Lupin Shares Tank 17% On USFDA's Warning Letter, Brokerages Give 'Buy' Rating
The Lupin shares crashed over 17% to trade at Rs 851 soon after it announced, in a stock filing, that it has received a warning letter issued by the USFDA pertaining to its plants located in Goa and Indore (Pithampur Unit II).
-
Divi's Lab Shares Close 17% Higher As USFDA's Import Ban Set To Be Lifted From Vizag Plant
Divi's Laboratories has informed the NSE in a stock exchange filing that the USFDA will soon lift the import Alert 66-40 and will move to close out the warning letter issued to the company's unit-II at Vishakhapatnam.
-
USFDA To Lift Import Alert On Visakhapatnam Unit: Divi's Labs
The company had earlier said that the USFDA had issued an import alert under clauses 99-32 and 66-40 in March, and a warning letter later for the Vishakhapatnam facility.
-
USFDA issues Warning Letter To Divis Labs For Vishakhapatnam Unit
The United States Food and Drug Administration (USFDA) has issued warning letter for the company's Unit-II at Vishakhapatnam, Divis Laboratories said in a BSE filing.
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Wockhardt Plunges After US Drug Regulator Warns Subsidiary
After a weak opening, shares of the company further went down by 6.67 per cent to Rs 701 on BSE.
-
USFDA Issues Warning Letter To Wockhardt's US Arm
The company, however, did not provide any details about the reasons for the issuance of warning letter and when it was issued.
-
USFDA Issues Warning Letter To Wockhardt's Ankleshwar Plant
USFDA has already banned import of products from the facility into the US market since August 5, 2016.
-
US Food Regulator Made 9 Observations Post Halol Unit Inspection: Sun Pharma
Sun Pharma was earlier issued a warning letter by the USFDA for its Halol facility in December 2015.
-
FDA Warns Former Sun Pharma US Drug Factory Over Quality Concerns
The US Food and Drug Administration has pulled up a former Sun Pharmaceutical drug factory for "knowingly" releasing 27 lots of the hypertension drug clonidine last year, despite proof that the raw materials used may have been contaminated.
-
Awaiting USFDA Response on Re-Mediation Efforts of 3 Units: Dr Reddys Lab
Dr Reddys Laboratories (DRL) is awaiting a response from USFDA for future course of action over its three plants, for which the health regulator had issued warning letter, as the drug firm has completed its comprehensive corrective and preventive action plan (CAPA).
-
IPCA Labs Shares Crash on Warning Letter from USFDA
IPCA Laboratories shares crashed 16.27 per cent on Monday after the drugmaker said it has received a warning letter from US drug regulator highlighting manufacturing quality lapses at three of its units.
-
Cadila Healthcare Receives FDA Warning Letter, Shares Plunge
The shares of Cadila Healthcare slipped over 15 per cent to Rs 324 as the company received a warning letter from the USFDA for two plant-- Moraiya formulation facility and Ahmedabad active pharmaceutical ingredient facility (Zyfine).
