USFDA completes Waluj facility inspection: Wockhardt
Drug firm Wockhardt, which has been under the USFDA's scanner, Wednesday said that the American health regulator has completed the inspection of its Waluj facility in Maharashtra.
May 27, 2015, 20:59 PM IST
Wockhardt recalls 93K bottles of Captopril tablets from US
Recall has been initiated as the tablets failed to meet tablet/capsule specifications given by the USFDA.
May 14, 2015, 17:40 PM IST
Glenmark gets tentative USFDA nod for generic psoriasis cream
The product is the therapeutic equivalent of Danish pharma firm Leo Pharma A/S Dovonex's topical cream of the same strength.
May 04, 2015, 13:32 PM IST
Wockhardt recalls 13 drugs in US after FDA concerns
Pharmaceuticals major Wockhardt is recalling 13 drugs in the US, manufactured at its two units at Chikalthana and Waluj in Maharashtra, which were under import restrictions from the USFDA.
Apr 28, 2015, 10:37 AM IST
Claris gets USFDA supplemental nod for Fluconazole injection
"The company has received the supplemental Abbreviated New Drug Application (ANDA) for Fluconazole injection in the US," Claris Lifesciences said in a filing to the BSE.
Apr 21, 2015, 13:53 PM IST
Aurobindo gets USFDA nod to sell antibiotic oral suspension
The approval by the USFDA is for strengths of 100 mg/5 ml and 200 mg/5 ml and the product is ready for launch, Aurobindo Pharma said in a statement.
Apr 15, 2015, 13:04 PM IST
Aurobindo gets USFDA nod for Atracurium Besylate injections
Drug major Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Atracurium Besylate injections in the American market.
Apr 09, 2015, 14:12 PM IST
IPCA Labs shares tank 13% on USFDA's import alert
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.
Mar 25, 2015, 13:44 PM IST
USFDA issues import alert on two plants of Aarti Drugs
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.
Mar 24, 2015, 14:20 PM IST
Aurobindo gets tentative nod from USFDA for Lacosamide tablets
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.
Mar 19, 2015, 17:32 PM IST
Indian companies not singled out for inspections, says USFDA
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.
Mar 18, 2015, 20:29 PM IST
Sun Pharma recalls 5,322 bottles of Ketorolac eye drop in US
Sun Pharma is voluntarily recalling 5,322 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications.
Mar 08, 2015, 11:01 AM IST
Ranbaxy loses approvals, exclusivity of 2 drugs in US
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.
Mar 03, 2015, 15:50 PM IST
Wockhardt says FDA raises new concerns about Waluj plant
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.
Feb 26, 2015, 16:41 PM IST
Lupin gets USFDA nod for ophthalmic solution
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).
Feb 23, 2015, 15:42 PM IST
US FDA Commissioner Margaret Hamburg to step down
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.
Feb 06, 2015, 02:53 AM IST
USFDA to increase its India headcount
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.
Feb 04, 2015, 17:13 PM IST
Lupin gets USFDA approval for diarrhoea drug
"Lupin Pharmaceuticals Inc (LPI), the company's US subsidiary would commence marketing the product shortly," it added.
Feb 02, 2015, 15:42 PM IST
India wants its officials during FDA inspections at drug units
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.
Jan 11, 2015, 12:13 PM IST
Cadila recalls 15,144 bottles of hypertension drug in US
Cadila Healthcare is voluntarily recalling 15,144 bottles of its anti-hypertension drug Amlodipine Besylate tablets in the US market, according to the USFDA.
Dec 08, 2014, 18:57 PM IST
