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Global Pharma recalls 50,000 tubes of contaminated eye drops in US: USFDA

Global Pharma Healthcare is recalling 50,000 tubes of eye drops in the US market due to bacterial c…

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Sun Pharma's Halol unit put under 'import alert' by USFDA

Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed un…

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Dr Reddy's, Sun Pharma recall drugs in US market: USFDA

New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recall…

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USFDA rejects SPARC's cancer drug application

"The company has received a Complete Response Letter (CRL) from the United States Food & Drug …

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USFDA issues warning letter to Cipla for Goa plant

The significant violations included company's failure "to clean, maintain, and, as appropriate for…

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Alkem Labs gets EIR from USFDA for Baddi facility

The Baddi facility was inspected by the United States Food and Drug Administration (USFDA) from Fe…

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USFDA red flags Torrent Pharma's US-based plant for manufacturing violations

New Delhi, Nov 24 () The American health regulator has pulled up Torrent Pharmaceuticals' US-based …

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USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory action

New Delhi, Jan 30 () Drug firm Aurobindo Pharma on Thursday reported that the US health regulator h…

PTI   


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Strides Pharma Science receives EIR for Bengaluru facility from USFDA

"The flagship facility in Bengaluru is the largest manufacturing facility for the company with cap…

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USFDA classifies Sun Pharma's Halol facility as official action indicated

"Sun Pharma continues to cooperate with the USFDA and will undertake all necessary steps to resolve…

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Strides ceases distribution of ranitidine tablets in America as USFDA asks makers to withdraw

On Wednesday, the US Food and Drug Administration (USFDA) published a statement and issued letters…

PTI   


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Drug firm Lupin gets warning letter from US health regulator for Somerset facility

"The company does not believe that the warning letter will have an impact on disruption of supp…

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Alembic Pharma receives 4 observations from USFDA for Panelav facility

"The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceutical…

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Aurobindo Pharma gets EIR with VAI status from USFDA for Hyderabad facility

"Further to our intimation dated November 6, 2019 with regard to the USFDA inspection of Unit VIII…

PTI   


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USFDA pulls up Mylan for manufacturing violations at Andhra plant

New Delhi, Nov 18 () American health regulator USFDA has pulled up Mylan Laboratories for violation…

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Alembic Pharma gets USFDA nod for generic cancer drug

Fluorouracil injection is indicated for the treatment of patients with adenocarcinoma of the colon …

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Lupin gets EIR from USFDA for Florida-based inhalation research centre

"The receipt of the EIR with satisfactory 'voluntary action indicated' status validates our commit…

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Haldirams, Britannia and HUL cannot sell its food products in the US. Know why

Several companies argued that the bulk of products were shipped without their knowledge by unauthor…