Sun Pharma Halol Facility
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Sun Pharma Says Gujarat Facility Listed Under US Regulator's Import Alert
The import alert means all future shipments of products made at Halol can be refused admission to the US market until the facility becomes compliant with the FDA's Current Good Manufacturing Practice standards,
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Sun Pharma Gets Clearance For Halol Facility From US Regulator, Shares Jump
The US FDA conducted inspection at Sun Pharmaceutical Industries' facility in Halol from February 12 to February 23.
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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 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.
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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.
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Sun Pharma to Ask US Regulator for Halol Reinspection in March Quarter
Drug major Sun Pharmaceutical Industries may ask the US Food and Drug Administration (FDA) in the first quarter of next fiscal year for reinspection of its Halol facility as it undertakes remediation measures to make the plant compliant to good manufacturing practice norms.
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Sun Pharma Extends Rally on Anti-Cancer Drug Approval
Sun Pharma shares have underperformed the broader Nifty in the last three months as the company is struggling with issues at its Halol manufacturing facility, Ranbaxy integration as well as pricing pressure in the United States, the company's largest market.
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Sun Pharma Falls 3% on Cautious FY16 Outlook
Sun Pharma shares fell over 3 per cent on Monday after India's biggest pharma company said it expects revenues and net profit to be adversely hit in the short term due to supply constraints at its Halol facility in Gujarat and high expenses arising out of Ranbaxy integration as well as remedial actions.
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Sun Pharma, SPARC Fall As US Revokes Nod for Epilepsy Drug
The US regulator cited pending compliance issue at Sun Pharma's Halol facility for revoking its approval for Elepsia XR (Levetiracetam ER). SPARC was to manufacture a compound of the epilepsy drug at the Halol unit.
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SPARC Surges Over 8% on USFDA Nod for Epilepsy Drug
The product will be manufactured by its parent company Sun Pharmaceutical Industries at its Halol facility in Gujarat.
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Sun Pharma Says Gujarat Facility Listed Under US Regulator's Import Alert
The import alert means all future shipments of products made at Halol can be refused admission to the US market until the facility becomes compliant with the FDA's Current Good Manufacturing Practice standards,
-
Sun Pharma Gets Clearance For Halol Facility From US Regulator, Shares Jump
The US FDA conducted inspection at Sun Pharmaceutical Industries' facility in Halol from February 12 to February 23.
-
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.
-
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.
-
Sun Pharma to Ask US Regulator for Halol Reinspection in March Quarter
Drug major Sun Pharmaceutical Industries may ask the US Food and Drug Administration (FDA) in the first quarter of next fiscal year for reinspection of its Halol facility as it undertakes remediation measures to make the plant compliant to good manufacturing practice norms.
-
Sun Pharma Extends Rally on Anti-Cancer Drug Approval
Sun Pharma shares have underperformed the broader Nifty in the last three months as the company is struggling with issues at its Halol manufacturing facility, Ranbaxy integration as well as pricing pressure in the United States, the company's largest market.
-
Sun Pharma Falls 3% on Cautious FY16 Outlook
Sun Pharma shares fell over 3 per cent on Monday after India's biggest pharma company said it expects revenues and net profit to be adversely hit in the short term due to supply constraints at its Halol facility in Gujarat and high expenses arising out of Ranbaxy integration as well as remedial actions.
-
Sun Pharma, SPARC Fall As US Revokes Nod for Epilepsy Drug
The US regulator cited pending compliance issue at Sun Pharma's Halol facility for revoking its approval for Elepsia XR (Levetiracetam ER). SPARC was to manufacture a compound of the epilepsy drug at the Halol unit.
-
SPARC Surges Over 8% on USFDA Nod for Epilepsy Drug
The product will be manufactured by its parent company Sun Pharmaceutical Industries at its Halol facility in Gujarat.
