Us Drug Regulator
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Cough Syrup Linked To Child Deaths In India Not Shipped To US: Drug Regulator
The US Food and Drug Administration confirmed on Friday that toxic cough syrups linked to children's deaths in India had not been shipped to the United States.
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Lupin Scouts for Acquisitions in US
Looking to bolster its overseas presence, drug major Lupin is scouting for acquisition opportunities in the US market, especially in inhalers and injectables segments.
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Zydus Cadila Gets US Drug Regulator's Approval for Anti-viral Drug Acyclovir
The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, Zydus Cadila said.
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US Regulator Likely To Clear 3rd Shot For Those With Weak Immune Systems
U.S. drug regulators are set to clear a third dose of Covid vaccines for people with weak immune systems as a new study showed the benefits of an extra shot in transplant patients.
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Sun Pharma Says US Regulator To Lift Ban On Mohali Drug Plant
Sun gained the plant along with its acquisition of Ranbaxy Laboratories in 2015 and has been attempting to fix quality control problems there that the US Food and Drug Administration (FDA) identified in 2013.
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US Regulator Excludes Ceftriazone Sodium From Import Alert: Wockhardt
Wockhardt said the FDA had on September 30, 2016 posted on its website an update on the Import Alert 66-40 "regarding company's API Unit at Ankleshwar".
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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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US Drug Regulator Revokes Approval for Sun Pharma's Seizure Drug
The move comes as a setback to SPARC, the research arm of India's largest drugmaker, Sun Pharmaceutical Industries Ltd. The drug, Elepsia XR, was its first to receive an FDA approval.
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US Drug Regulator Inspects Sharon Bio-Medicine's Dehradun Plant
USFDA had inspected company's manufacturing facility at Taloja near Navi Mumbai last month, it added.
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US Drug Regulator Hikes Fee for Drug Approvals, Cuts Unit Inspection Charge
However, the fees for facility inspection of foreign companies have been reduced, which may encourage more firms to opt for audit of their facilities by the regulator.
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Orchid Chemicals Gets US Drug Regulator's Nod for Anti-Bacterial Tablets
The approval is with 180 days of generic drug exclusivity, it added.
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Dr Reddy's Says US Drug Regulator Raises Concerns About Plant
Dr Reddy's said it received "inspectional observations" from the FDA after the agency's staff inspected the plant. It was not immediately clear what the observations referred to, and a spokeswoman for Dr Reddy's did not immediately respond to a request for comment.
-
Lupin Scouts for Acquisitions in US
Looking to bolster its overseas presence, drug major Lupin is scouting for acquisition opportunities in the US market, especially in inhalers and injectables segments.
-
Zydus Cadila Gets US Drug Regulator's Approval for Anti-viral Drug Acyclovir
The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, Zydus Cadila said.
-
Jubilant gets US regulator's nod for generic drug
Jubilant Life Sciences on Friday said it has received approval from the US Food and Drug Administration (FDA) to market a generic version of GD Searle's Aldactone, a drug used to treat fluid retention, in the American market.
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Cough Syrup Linked To Child Deaths In India Not Shipped To US: Drug Regulator
The US Food and Drug Administration confirmed on Friday that toxic cough syrups linked to children's deaths in India had not been shipped to the United States.
-
Lupin Scouts for Acquisitions in US
Looking to bolster its overseas presence, drug major Lupin is scouting for acquisition opportunities in the US market, especially in inhalers and injectables segments.
-
Zydus Cadila Gets US Drug Regulator's Approval for Anti-viral Drug Acyclovir
The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, Zydus Cadila said.
-
US Regulator Likely To Clear 3rd Shot For Those With Weak Immune Systems
U.S. drug regulators are set to clear a third dose of Covid vaccines for people with weak immune systems as a new study showed the benefits of an extra shot in transplant patients.
-
Sun Pharma Says US Regulator To Lift Ban On Mohali Drug Plant
Sun gained the plant along with its acquisition of Ranbaxy Laboratories in 2015 and has been attempting to fix quality control problems there that the US Food and Drug Administration (FDA) identified in 2013.
-
US Regulator Excludes Ceftriazone Sodium From Import Alert: Wockhardt
Wockhardt said the FDA had on September 30, 2016 posted on its website an update on the Import Alert 66-40 "regarding company's API Unit at Ankleshwar".
-
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.
-
US Drug Regulator Revokes Approval for Sun Pharma's Seizure Drug
The move comes as a setback to SPARC, the research arm of India's largest drugmaker, Sun Pharmaceutical Industries Ltd. The drug, Elepsia XR, was its first to receive an FDA approval.
-
US Drug Regulator Inspects Sharon Bio-Medicine's Dehradun Plant
USFDA had inspected company's manufacturing facility at Taloja near Navi Mumbai last month, it added.
-
US Drug Regulator Hikes Fee for Drug Approvals, Cuts Unit Inspection Charge
However, the fees for facility inspection of foreign companies have been reduced, which may encourage more firms to opt for audit of their facilities by the regulator.
-
Orchid Chemicals Gets US Drug Regulator's Nod for Anti-Bacterial Tablets
The approval is with 180 days of generic drug exclusivity, it added.
-
Dr Reddy's Says US Drug Regulator Raises Concerns About Plant
Dr Reddy's said it received "inspectional observations" from the FDA after the agency's staff inspected the plant. It was not immediately clear what the observations referred to, and a spokeswoman for Dr Reddy's did not immediately respond to a request for comment.
-
Lupin Scouts for Acquisitions in US
Looking to bolster its overseas presence, drug major Lupin is scouting for acquisition opportunities in the US market, especially in inhalers and injectables segments.
-
Zydus Cadila Gets US Drug Regulator's Approval for Anti-viral Drug Acyclovir
The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, Zydus Cadila said.
-
Jubilant gets US regulator's nod for generic drug
Jubilant Life Sciences on Friday said it has received approval from the US Food and Drug Administration (FDA) to market a generic version of GD Searle's Aldactone, a drug used to treat fluid retention, in the American market.
