Lupin Tarapur API facility gets 3 observations from USFDA Medical Dialogues Bureau24 Sept 2019 9:45 AM ISTThe inspection of the Tarapur facility was carried out by the US health regulator between September 16 to September 20, 2019, said Lupin.Mumbai:...
Laurus Labs to acquire subsidiary of ASPEN Pharmacare Farhat Nasim24 Sept 2019 9:30 AM IST"The completion of conditions precedent, by way of cash consideration of ZAR 75,000, the Pharmaceutical company said in a statement here. The...
Indoco Remedies sterile manufacturing plant in Goa gets 2 observations from UK-MHRA Medical Dialogues Bureau24 Sept 2019 9:17 AM IST'The successful closure of the MHRA inspection is encouraging and reflects the immense learning and adaption by our technical team. The Sterile...
CCI approves sale, restructuring of Apollo Pharmacy Medical Dialogues Bureau24 Sept 2019 9:15 AM ISTNEW DELHI: The Competition Commission on Monday said it has approved the restructuring of Apollo Hospitals Enterprise Ltd's pharmacy business and its...
Make drugmakers upload data in SUGAM portal: CDSCO Committee recommends State Drug Authorities Farhat Nasim23 Sept 2019 5:46 PM ISTNew Delhi: The Drugs Consultative Committee (DCC), functional under Central Drugs Standard Control Organisation (CDSCO), recently recommended the...
Novo Nordisk wins USFDA nod for oral diabetes drug Rybelsus Medical Dialogues Bureau23 Sept 2019 2:16 PM ISTNovo Nordisk did not disclose what it plans to charge for the new oral treatment, called Rybelsus, but said it would be "competitively priced" with...
Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru Medical Dialogues Bureau23 Sept 2019 10:15 AM IST"At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the...
Dr Reddys suspends worldwide supply of Ranitidine over cancer fears until USFDA probe over Medical Dialogues Bureau23 Sept 2019 10:00 AM ISTRanitidine is an Over-The-Counter (OTC) and prescription drug which decreases the amount of acid created by the stomach.Hyderabad: Dr Reddy's...
Cipla API facility in Bengaluru gets EIR from USFDA Medical Dialogues Bureau23 Sept 2019 9:45 AM ISTCipla had earlier said that USFDA issued seven observations after conducting a routine 'CGMP inspection' at Cipla's API manufacturing facility in...
Torrent Pharma expands recall of Losartan tablets in US over carcinogen impurity Medical Dialogues Bureau23 Sept 2019 9:00 AM IST"The recall is expanded to include an additional three lots of Losartan potassium tablets USP and 2 lots of Losartan potassium/hydrochlorothiazide...
CDSCO directs makers of Aceclofenac, Drotaverine Hydrochloride FDC to conduct Active Post Marketing Surveillance on atleast 200 patients Medical Dialogues Bureau22 Sept 2019 11:30 AM ISTNew Delhi: Through a recent notification, the Central Drugs Standard Control Organisation(CDSCO) has directed all the manufacturers of Fixed-Dose...
Unichem Labs API facility in Kolhapur clears CGMP surveillance by USFDA Medical Dialogues Bureau22 Sept 2019 10:00 AM ISTNew Delhi: Drug firm Unichem Laboratories recently said the US health regulator has concluded inspection of its new facility at Kolhapur, Maharashtra...