Page 2 - Us Food And Drug Administration
Granules India arm gets USFDA nod for generic version of Roche antiviral
Drug firm Granules India Ltd on Wednesday said its foreign arm has received approval from the US health regulator for Valganciclovir hydrochloride oral solution, an antiviral medication. "The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a-wholly owned foreign subsidiary of Granules India Ltd for Valganciclovir hydrochloride for oral solution, 50 mg/ml," the company said in a regulatory filing. It is bioequivalent to the reference listed drug product (RLD) -- Valcyte for oral solution, 50 mg/m, of Roche Palo Alto LLC, the filing said. Valganciclovir hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections. Shares of Granules India were trading at Rs 153 a piece on BSE, up 4.83 per cent from the previous close.
 "Granules India arm gets USFDA nod for generic version of Roche antiviral")
Q3 results preview: US regulatory overhang on earnings of pharma firms
The US is Indian pharma's largest export market and Indian drugmakers account for a little over 30 per cent of generic drugs sold in that country
Aurobindo recalls heartburn drug ranitidine, two others from US market
Development follows regulatory compliance issues being faced by several of its plants back home; Ranitidine taken off due to the presence of carcinogenic compound
Exposure to US market causing constant FDA scrutiny for big drug firms
Dr Reddy's was in the news for falling short of expectations during routine audits conducted by the US drug regulator
 "Exposure to US market causing constant FDA scrutiny for big drug firms")
Lupin launches generic drug in US for treatment, prevention of hypokalemia
The company had earlier received approval for the product from the United States Food and Drug Administration
 "Lupin launches generic drug in US for treatment, prevention of hypokalemia")
Alembic Pharma gets USFDA nod for ointment to treat various skin disease
Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA
 "Alembic Pharma gets USFDA nod for ointment to treat various skin disease")
Indian pharmaceutical companies spread business to avoid regulatory ire
Increased USFDA import alerts could be reason for finding alternative sites
 "Indian pharmaceutical companies spread business to avoid regulatory ire")
The pharma challenge
India must act urgently on counterfeit drugs
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
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")
US health regulator rejected 12k products since Jan 2011: Sitharaman
The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products and the like
 "US health regulator rejected 12k products since Jan 2011: Sitharaman")
