Granules India gets 2 USFDA observations for Chantilly facility Medical Dialogues Bureau23 Aug 2019 11:46 AM IST"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned...
Natco Pharma gets 6 USFDA observations for API facility near Hyderabad Medical Dialogues Bureau13 Aug 2019 1:16 PM ISTNatco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.NEW...
Natco Pharma gets EIR from USFDA for Kothur facility Medical Dialogues Bureau6 Aug 2019 4:35 PM ISTNew Delhi: Drug firm Natco Pharma on Monday said it has received establishment inspection report (EIR) from the US health regulator for its Kothur...
Cadila Healthcare gets EIR report on Ahmedabad SEZ facility Medical Dialogues Bureau18 Jun 2019 1:57 PM ISTNew Delhi: Drug firm Cadila Healthcare Monday said it has received establishment inspection report from the US health regulator with voluntary action...
Natco Pharma- Kothur facility gets 9 observations from USFDA Medical Dialogues Bureau7 Jun 2019 2:21 PM ISTNEW DELHI: Natco Pharma Thursday said the US health regulator has made nine observations after the completion of inspection of its Kothur formulation...
Zydus Cadila gets USFDA nod for Chlorthalidone tablets to treat high BP Farhat Nasim13 May 2019 10:31 AM ISTZydus Cadila said Chlorthalidone tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad.New Delhi: Drug...
Zydus Cadila gets USFDA nod for Phentermine Hydrochloride orally disintegrating tablets Medical Dialogues Bureau26 April 2019 8:59 AM ISTPhentermine Hydrochloride orally disintegrating tablets is used together with diet and exercise to treat obesity (overweight) in people with risk...
Zydus Cadila gets final USFDA nod to generic version of Diamox for injection Farhat Nasim18 April 2019 10:00 AM IST Acetazolamide injection is a generic version of Diamox for injection.New Delhi: Drug firm Zydus Cadila Wednesday said it has received the final nod...
Alkem Labs gets 8 USFDA observations for St Louis facility Farhat Nasim24 March 2019 9:50 AM ISTThe United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company's manufacturing plant at St Louis...
Unichem Labs gets USFDA nod to market Allopurinol tablets Farhat Nasim15 March 2019 9:35 AM ISTAllopurinol tablets will be commercialised from company's Ghaziabad plant, Unichem Laboratories said.New Delhi: Drug firm Unichem Laboratories...
USFDA completes audit for Dr Reddys Shreveport plant, no observations issued Medical Dialogues Bureau23 Feb 2019 9:30 AM IST"The audit of our formulations Shreveport plant, Louisiana, USA, by the United States Food and Drug Administration (USFDA) has been completed with...
Laurus Labs gets tentative USFDA approval for HIV combo drug Farhat Nasim4 Feb 2019 9:30 AM ISTHyderabad: Indian pharmaceutical player, Laurus Labs said Sunday it has received tentative approval from the United States Food and Drug...
