Mar 08, 2017 at 13:29 | Source: Moneycontrol.com
Drug maker Dr Reddys Laboratories will be put to a crucial test in the second week of April as the company gears up for major USFDA audits at its facilities in Srikakulam located some 70 kms away from port city of Visakhapatnam.
Mar 08, 2017 at 09:25 | Source: Moneycontrol.com
The US drug regulator cleared the companys investigational new drug application to begin phase two study of GSP 304 that will be used to treat chronic obstructive pulmonary disease.
Mar 08, 2017 at 09:16 | Source: Moneycontrol.com
The pharma major announced a dividend of Rs 3.25 a share; it even received a nod from US FDA for a drug that is used to treat spasticity in relaxing muscles
Mar 08, 2017 at 08:14 | Source: Moneycontrol.com
Tracking global cues as well as cautious stance ahead of key exit polls data, the Street may see tepid opening. Wockhardt will be on investors radar following the warning letter issued by US FDA for its US plant.
Mar 07, 2017 at 13:34 | Source: PTI
The company "announced today the launch of generic paxil CR extended release tablets, 12.5 mg, 25 mg and 37.5 mg, having received an approval from the United States Food and Drug Administration (FDA) earlier", Lupin said in a BSE filing.
Mar 06, 2017 at 13:35 | Source: Moneycontrol.com
"The two observations cited are, in the opinion of the company, correctable ones in respect of which the company will file the necessary response within the stipulated period of 15 working days," Unichem said in a statement to stock exchanges.
Mar 03, 2017 at 13:59 | Source: Moneycontrol.com
The court allowed the firm to make and sell Canmab, a cancer drug of the company. Stock was under pressure so far on the back of inspection reports. The management, earlier this morning, stated the inspections were expected as its dossiers were accepted by US FDA and EMA.
Mar 03, 2017 at 11:26 | Source: CNBC-TV18
Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.
Mar 02, 2017 at 14:39 | Source: Moneycontrol.com
The US Food and Drug Administration (FDA) gave three observations under Form 483 for its formulations manufacturing facility at Baddi. These were related to pre-approval inspections for a specific product filed.
Mar 02, 2017 at 13:45 | Source: CNBC-TV18
Biotech company, Biocon will see two crucial inspections later this month and in early April. Companys manufacturing sites will come up for inspections by the European medicines agency later this month and next will be an inspection by the US FDA.