Page 35 - Usfda
Natco Pharma's API facility near Hyderabad gets 6 USFDA observations
The company said that key points of the observations in Form 483 are the supplier and service provider agreements to be made more robust
 "Natco Pharma's API facility near Hyderabad gets 6 USFDA observations")
Fund managers bet on pharma sector as pricing pressure in US is stabilising
The Indian pharma sector has many attractive opportunities before it, such as the growing adoption of generic drugs in developed markets
 "Fund managers bet on pharma sector as pricing pressure in US is stabilising")
Lupin gets Establishment Inspection Report from FDA for Aurangabad facility
The facility was inspected by the US Food and Drug Administration
 "Lupin gets Establishment Inspection Report from FDA for Aurangabad facility")
Active pharmaceutical ingredients focus helps drug firms offset slowdown
Besides captive consumption, the company also supplies APIs to external customers across international markets
 "Active pharmaceutical ingredients focus helps drug firms offset slowdown")
Alembic Pharma gets USFDA nod for neuropathic pain management drug
The approved product is therapeutically equivalent to the reference listed drug Lyrica Capsules
 "Alembic Pharma gets USFDA nod for neuropathic pain management drug")
InvaGen Pharma gets USFDA approval for neuropathic pain management drug
Cipla said the approved product is a generic therapeutic equivalent version of Pfizer's Lyrica
 "InvaGen Pharma gets USFDA approval for neuropathic pain management drug")
Strides Bengaluru unit gets 'Voluntary Indicated Action' status from USFDA
The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage products across multiple formats
 "Strides Bengaluru unit gets 'Voluntary Indicated Action' status from USFDA")
Zydus Pharma gets USFDA nod to market attention-deficit hyperactivity drug
The final approval from the United States food and drug administration (USFDA) is to market Dextroamphetamine Saccharate
 "Zydus Pharma gets USFDA nod to market attention-deficit hyperactivity drug")
Dr Reddy's Laboratories unveils generic version of Allegra-D in US
Allegra-D 12 HR is a trademark of Aventisub II Inc
 "Dr Reddy's Laboratories unveils generic version of Allegra-D in US")
Caplin Labs gets USFDA nod for injection to prevent excessive blood loss
Caplin Steriles said it has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far
 "Caplin Labs gets USFDA nod for injection to prevent excessive blood loss")
USFDA completes Chennai facility audit with zero observations: Natco Pharma
Shares of Natco Pharma were trading 0.35 per cent higher at Rs 529.95 apiece on BSE
 "USFDA completes Chennai facility audit with zero observations: Natco Pharma")
Bird faeces on packages in United Breweries warehouse, says USFDA
None of the pest control records addressed the issue of birds
 "Bird faeces on packages in United Breweries warehouse, says USFDA")
Glenmark receives final nod from USFDA for drug to treat chronic angina
Glenmark Pharmaceuticals Tuesday said it has received final nod from the US health regulator for its Ranolazine extended-release tablets used for treatment of chronic angina. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Ranolazine extended-release tablets in the strengths of 500 mg and 1,000 mg, the company said in a statement. The product is a generic version of Gilead Sciences Inc's Ranexa extended-release tablets in the same strengths, it added. According to IQVIA sales data for the 12-month period ended May 2019, Ranexa extended-release tablets, 500 mg and 1,000 mg market (which includes brand and all available therapeutic equivalents) achieved annual sales of around USD 929 million, Glenmark said. The company's current portfolio consists of 158 products authorised for distribution in the US marketplace and 57 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it ...
 "Glenmark receives final nod from USFDA for drug to treat chronic angina")
USFDA issues 12 observations for three units of Biocon in Malaysia
The company, however, did not provide any details about the observations made by the US regulator
 "USFDA issues 12 observations for three units of Biocon in Malaysia")
Strides Pharma Puducherry unit receives warning letter from USFDA
The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator.
Dr Reddy's Laboratories, Cipla arm recall drugs from American market
The USFDA has classified both the recalls as a Class-II recall
 "Dr Reddy's Laboratories, Cipla arm recall drugs from American market")
Fresh approvals for generic hypertension drug opens room for Indian firms
Sources revealed that the firms that got approval planned to launch the product in the US at the earliest
USFDA drug approvals at all-time high; Indian firms get 35-40% of nods
The regulator has bettered last year's numbers with 971 approval actions this year
Teva migraine drug gets US FDA approval, bolstering turnaround plan
Ajovy injection seen generating $500 million in sales by 2022
USFDA approves Vidya Herbs' plant extract unit in Bengaluru
Apart from maufacturing herbal extracts and essential oils, the firm has also diversified into coffee production
 "USFDA approves Vidya Herbs' plant extract unit in Bengaluru")