Usfda Observations
- All
- News
-
Glenmark Pharma Receives 7 Observations From US Regulator On Baddi Unit, Shares Fall
Glenmark Pharmaceuticals said the Baddi unit contributes approximately 10 per cent of the revenue of US sales.
-
Dr Reddy's Lab Gets EIR For 2 Facilities, Shares Jump 7%
Dr Reddy's Laboratories said it has received zero observations for its custom pharmaceutical services facility, technology development centre, at Miyapur in Hyderabad after audit of the facility by the USFDA.
-
USFDA Issues 11 Observations For Sun Pharma's Dadra Facility
The company's Dadra facility underwent an inspection byUnited States Food and Drug Administration (USFDA) recently.
-
Glenmark's Ankleshwar Plant Gets Inspection Report From USFDA
Glenmark was clarifying to the stock exchanges over a news report which claimed that its Ankleshwar plant received observations from the USFDA during its inspection in December 2016.
-
Ajanta Pharma Gets USFDA Observation For Paithan Facility
Drug firm Ajanta Pharma on Thursday said the US health regulator has issued one observation for its Paithan facility in Aurangabad after the inspection.
-
USFDA Makes 6 Observations At Natco Pharma's Kothur Facility
Natco Pharma said it will provide due justifications and corrective action plan within next 15 working days to the address the USFDA observations.
-
Alkem Laboratories Shares Slump On USFDA Observations
The Mumbai-based pharmaceuticals company said the US health regulator had conducted an inspection at the Ankleshwar facility from December 5 to December 9.
-
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 Made 9 Observations Post Halol Unit Inspection: Sun Pharma
The United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Pharma said in a BSE filing.
-
Divi's Labs Slumps 6% After FDA Observations On Vizag Facility
The company said Unit-II at Visakhapatnam, Andhra Pradesh, has had an inspection by the US Food and Drug Administration (USFDA) from November 29 to December 6.
-
Divi's Labs Gets 5 Observations From USFDA For Vizag Plant
The company manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at the manufacturing plant.
-
Sun Pharma Slumps As BSE Seeks Clarification On USFDA Observation
Shares of Sun Pharmaceutical Industries fell as much as 4.55 per cent to hit intraday low of Rs 674 after the Bombay Stock Exchange sought clarification from Sun Pharma.
-
Alkem Laboratories Slumps After US FDA's Observations On Daman Plant
Alkem Laboratories said that the US regulator had conducted an inspection at the company's manufacturing facility located at Daman from September 20 to September 29, 2016.
-
Alembic Pharma Says Plants Successfully Inspected By USFDA
The company, however, did not provide any details about the observations it has received from the United States Food and Drug Administration.
-
Natco Pharma Shares Slump On FDA Observations
Shares of Natco Pharma slumped as much as 11 per cent to hit a low of Rs 417 after the Hyderabad-based healthcare company announced on Sunday that it has received observations by US Food & Drug Administration (USFDA) for two of its plants.
-
Glenmark Pharma Receives 7 Observations From US Regulator On Baddi Unit, Shares Fall
Glenmark Pharmaceuticals said the Baddi unit contributes approximately 10 per cent of the revenue of US sales.
-
Dr Reddy's Lab Gets EIR For 2 Facilities, Shares Jump 7%
Dr Reddy's Laboratories said it has received zero observations for its custom pharmaceutical services facility, technology development centre, at Miyapur in Hyderabad after audit of the facility by the USFDA.
-
USFDA Issues 11 Observations For Sun Pharma's Dadra Facility
The company's Dadra facility underwent an inspection byUnited States Food and Drug Administration (USFDA) recently.
-
Glenmark's Ankleshwar Plant Gets Inspection Report From USFDA
Glenmark was clarifying to the stock exchanges over a news report which claimed that its Ankleshwar plant received observations from the USFDA during its inspection in December 2016.
-
Ajanta Pharma Gets USFDA Observation For Paithan Facility
Drug firm Ajanta Pharma on Thursday said the US health regulator has issued one observation for its Paithan facility in Aurangabad after the inspection.
-
USFDA Makes 6 Observations At Natco Pharma's Kothur Facility
Natco Pharma said it will provide due justifications and corrective action plan within next 15 working days to the address the USFDA observations.
-
Alkem Laboratories Shares Slump On USFDA Observations
The Mumbai-based pharmaceuticals company said the US health regulator had conducted an inspection at the Ankleshwar facility from December 5 to December 9.
-
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 Made 9 Observations Post Halol Unit Inspection: Sun Pharma
The United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Pharma said in a BSE filing.
-
Divi's Labs Slumps 6% After FDA Observations On Vizag Facility
The company said Unit-II at Visakhapatnam, Andhra Pradesh, has had an inspection by the US Food and Drug Administration (USFDA) from November 29 to December 6.
-
Divi's Labs Gets 5 Observations From USFDA For Vizag Plant
The company manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at the manufacturing plant.
-
Sun Pharma Slumps As BSE Seeks Clarification On USFDA Observation
Shares of Sun Pharmaceutical Industries fell as much as 4.55 per cent to hit intraday low of Rs 674 after the Bombay Stock Exchange sought clarification from Sun Pharma.
-
Alkem Laboratories Slumps After US FDA's Observations On Daman Plant
Alkem Laboratories said that the US regulator had conducted an inspection at the company's manufacturing facility located at Daman from September 20 to September 29, 2016.
-
Alembic Pharma Says Plants Successfully Inspected By USFDA
The company, however, did not provide any details about the observations it has received from the United States Food and Drug Administration.
-
Natco Pharma Shares Slump On FDA Observations
Shares of Natco Pharma slumped as much as 11 per cent to hit a low of Rs 417 after the Hyderabad-based healthcare company announced on Sunday that it has received observations by US Food & Drug Administration (USFDA) for two of its plants.
