Page 4 - Us Food And Drug Administration

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

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

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

Indian pharmaceutical companies spread business to avoid regulatory ire

Increased USFDA import alerts could be reason for finding alternative sites

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

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

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