The US generic business has been a significant contributor to growth and profitability for Indian generic companies over the last decade, b...

According to a notification on USFDA's website, fee for Drug Master File was reduced to USD 47,829 for 2017-18 from USD 51,140 in the last ...

According to IMS data, the US market for this product is approximately $22 million with two generic players. The product will be launched i...

Since the Generic Drug User Fee Amendments implementation in Oct 2012, FDA inspections have doubled in India and China, which led to consid...

Interestingly, the growth came during the period when biggies like Sun Pharma and Dr Reddy's had reduced filings from their plants due to c...

The product will manufacture the product in Bengaluru, has received approval in 15 months under the USFDA new product clear regime.

The product received approval in 17 months under the USFDA's new product clearance regime of GDUFA. The product is ready for immediate laun...

The annual report released by the FDA’s OGD shows Indian companies have won some key approvals in the world’s biggest pharmaceuticals marke...

"I think the approvals are definitely on the uptick. Inspections are a reality of life."

Indian drug makers may be receiving an increasing number of approvals from the USFDA for drug launches in the United States.

One of the company's unit located at Taloja in Raigad district in Maharashtra has been inspected and audited by United States FDA.

The US regulator has issued a warning letter to Sharon Bio-medicine for failing to pay generic drug user fee by its owner for three years.

The Generic Drug User Fee Act (GDUFA) in the US was proposed to expedite the approval of generic drugs on collecting higher fees to process...

USFDA is increasing its inspections of facilities of drug makers in India to ensure compliance of approved manufacturing norms.

FDA has named at least five Indian companies among 43 drugmakers that have failed to meet their annual facility fee payment obligations.

The Pharmaceutical Export Promotion Council of India (Pharmexcil) has sought clarity from the United States Food and Drug Administration (U...

Pharmexcil has sought clarity from the United States Food and Drug Administration (USFDA ) on the new generic drug user fee norms.