IPCA Labs shares tank 13% on USFDA's import alert

Last Updated: Wednesday, March 25, 2015, 13:44

Shares of IPCA Laboratories slumped up to 13 percent Wednesday after import alerts were issued by the US FDA against two of its formulations manufacturing units.

USFDA issues import alert on two plants of Aarti Drugs

Last Updated: Tuesday, March 24, 2015, 14:20

Aarti Drugs on Tuesday said its two manufacturing facilities have received import alert from the US health regulator, a development which could impact the company's exports to the American market.

Aurobindo gets tentative nod from USFDA for Lacosamide tablets

Last Updated: Thursday, March 19, 2015, 17:32

Drug firm Aurobindo Pharma has received tentative approval from the US health regulator USFDA for its generic Lacosamide tablets used in treatment of partial seizures in epilepsy patients.

Indian companies not singled out for inspections, says USFDA

Last Updated: Wednesday, March 18, 2015, 20:29

The US health regulator said it is looking to increase training and joint inspections in various areas, including manufacturing while also discussing possibility of information sharing with Indian officials.

Sun Pharma recalls 5,322 bottles of Ketorolac eye drop in US

Last Updated: Sunday, March 8, 2015, 11:01

Sun Pharma is voluntarily recalling 5,322 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications.

Ranbaxy loses approvals, exclusivity of 2 drugs in US

Last Updated: Tuesday, March 3, 2015, 15:50

The DC Federal Court in the US has upheld the decision of the USFDA for rescinding tentative approvals given to it for generic digestive disorder drug Nexium and antiviral Valcyte.

Wockhardt says FDA raises new concerns about Waluj plant

Last Updated: Thursday, February 26, 2015, 16:41

Shares in Wockhardt Ltd fell as much as 5.3 percent on Thursday after the drugmaker said the U.S. Food and Drug Administration had raised fresh concerns about a plant already banned from exporting to the United States over quality issues.

Lupin gets USFDA nod for ophthalmic solution

Last Updated: Monday, February 23, 2015, 15:42

The company said it has received the final approval for its product, a generic version of Allergan Inc's Lumigan Ophthalmic Solution, from the US Food and Drug Administration (USFDA).

US FDA Commissioner Margaret Hamburg to step down

Last Updated: Friday, February 6, 2015, 02:53

Dr. Margaret Hamburg, who as commissioner of the US Food and Drug Administration (FDA) for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine and drug approvals, is stepping down, the agency said on Thursday.

USFDA to increase its India headcount

Last Updated: Wednesday, February 4, 2015, 17:13

The US Food and Drug Administration (FDA), which has offices in New Delhi and Mumbai, is in the process of increasing its headcount in India to 19.

Lupin gets USFDA approval for diarrhoea drug

Last Updated: Monday, February 2, 2015, 15:42

"Lupin Pharmaceuticals Inc (LPI), the company's US subsidiary would commence marketing the product shortly," it added.

India wants its officials during FDA inspections at drug units

Last Updated: Sunday, January 11, 2015, 12:13

Perturbed by Indian drug-makers frequently running into overseas regulatory problems, the government has requested the US health watchdog FDA to allow its officials during inspections of domestic pharma units.