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...
Granules India gets USFDA nod for Methylphenidate Hydrochloride ER capsules Farhat Nasim28 May 2019 10:00 AM ISTThe approved product, Methylphenidate Hydrochloride extended-release capsules, is bioequivalent to the reference listed drug product (RLD), Ritalin LA...
Cipla gets no USFDA observations for Indore facility Farhat Nasim18 May 2019 9:45 AM ISTThe US health regulator conducted a post-approval inspection at Cipla Ltd's Indore facility from 13th May to 17th May 2019. New Delhi: Drug firm Cipla...
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...
Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour Farhat Nasim9 May 2019 10:15 AM ISTUnichem Lab's approved drug is a generic copy of Zyrtec-D 12 Hour which is used for treating allergic rhinitis.New Delhi: Unichem Laboratories Tuesday...
Zydus Cadila gets USFDA nod to market 2 generic drugs Medical Dialogues Bureau1 May 2019 8:05 PM ISTNew Delhi: Drug firm Zydus Cadila Tuesday said it has received the final nod from the USFDA to market generic Bosentan tablets and Trientine...
Trump to keep fighting opioids 'until our job is done' Medical Dialogues Bureau28 April 2019 9:00 AM ISTWhile prescription opioids initially accounted for most deaths, the epidemic is now driven by illicit heroin and fentanyl.ATLANTA: President Donald...
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...
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...
Lupin Somerset facility gets OAI letter from USFDA Farhat Nasim18 March 2019 9:25 AM IST"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending...
USFDA Caution: Lupin gets OAI letter for MP plant Medical Dialogues Bureau17 March 2019 9:45 AM ISTLupin has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility...
