US FDA warns Emcure Pharmaceuticals
Emcure Pharmaceuticals joins the list of Indian pharma companies that have been accused by the US FDA of violating standard manufacturing practices
Mumbai: Emcure Pharmaceuticals on Monday joined the long list of Indian pharmaceutical companies that have been accused by the US Food and Drug Administration (FDA) of violating standard manufacturing practices.
Indian pharma companies have the largest number of FDA-approved plants outside the US—around 150.
Companies have suffered severe revenue loss in the past due to US FDA action.
Wockhardt, which earns about 60% of revenue from the US market, faced a huge loss after the FDA banned drugs from two of its plants in Maharashtra.
Sun Pharma, for which the US market accounts for 60% of its total sales, also faces a revenue loss after its Karkhadi plant was put on the FDA’s ban list.
Out of the $350-billion US pharma market, generic drug market is worth over $35 billion and India accounts for nearly 40% of generic drugs and over-the-counter products in the US.
“The spurt in the number of warning letters or import alerts against Indian companies stems from the FDA’s focus on boosting the US drug supply chain rather than any country-specific bias," said a report from CRISIL Ratings last year.
Here’s a list of companies that have faced the heat in the past two years.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!